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    Clinical Trial Results:
    Rectal Bacteriotherapy, Faecal microbiota transplantation or oral vancomycin for the treatment of recurrent Clostridium Difficile infection: A randomised controlled trial

    Summary
    EudraCT number
    		 2015-003062-82
    Trial protocol
    		 DK  
    Global end of trial date
    18 Sep 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 May 2021
    First version publication date
    01 May 2021
    Other versions
    Summary report(s)
    		 Table of all AEs and SAEs in the trial

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    RBI/FMT-CDI
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02774382
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Department of Medicine, Zealand University Hospital
    Sponsor organisation address
    Lykkebækvej 1, Køge, Denmark, 4600
    Public contact
    Clinical Trial Information, Department of Medicine, Zealand University Hospital, Køge, Denmark, +45 23345235, aala@regionsjaelland.dk
    Scientific contact
    Clinical Trial Information, Department of Medicine, Zealand University Hospital, Køge, Denmark, +45 47322405, aala@regionsjaelland.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Sep 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Sep 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Sep 2019
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate the treatment effect of rectal bacteriotherapy instillation (RBI) and faecal microbiota transplantation /FMT) against the standard antibotic treatment with vancomycin for patients with recurrent Clostridium Difficile infection in a randomised controlled trial
    Protection of trial subjects
    All participants gave written informed consent. The Regional Committee of Health Research Ethics (SJ-478), the Danish Medicines Agency (2015-003062-82) and The Danish Data Protection Agency (REG-103-2015) approved the study. We conducted the trial according to the Helsinki Declaration II and to the principles of Good Clinical Practice. An external party monitored the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 98
    Worldwide total number of subjects
    98
    EEA total number of subjects
    98
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    27
    From 65 to 84 years
    55
    85 years and over
    16

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 We assessed the eligibility of all consecutive individuals with a positive test for C difficile from all clinical microbiological laboratories in eastern Denmark from May 2017 - December 2018 at Zealand University Hospital and from June 2017 - March 2019 at Hvidovre University hospital. Predefined inclusion- and exclusion criteria were used.

    Pre-assignment
    Screening details
    		 We screened 1020 persons with a repeated positive CD test within 90 days, yet only included 98. Exclusion were primarily due to the person being asymptomatic at the time of testing or not being able to give informed consent. Furthermore, some were excluded due to having other GI-disease with diarrhoea or declined to participate

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Computer-generated stratified randomisation in blocks of six was used with allocation concealment in sealed opaque envelopes with sequential numbers for each stratum. An independent party conducted the block size, randomisation code and packing of envelopes. The trial personnel were blinded to this process. After allocation, the trial was open-label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Faecal microbiota transplantation (FMT)
    Arm description
    		 Participants were pre-treated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 36 hours prior to FMT. Frozen donor stool from a donor stool bank was administered by rectal enema once, but with a possibility to repeat it up to two times within 14 days after the first infusion. The indication for repetition was ongoing or new-onset diarrhoea (≥3 loose or liquid stools per day), as judged by a trial physician, without new testing for C difficile. We used a different donor when repeating FMTs.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Donor stool (not considered a medicinal product)
    Investigational medicinal product code
    Other name
    FMT
    Pharmaceutical forms
    Gastroenteral solution, Rectal suspension
    Routes of administration
    Gastroenteral use, Rectal use
    Dosage and administration details
    Frozen donor stool from a donor stool bank. One product consists of 50 g stool, 150 mL NaCl and 20 mL glycerol (85%). It was administered by rectal enema once, but with a possibility to repeat it up to two times within 14 days after the first infusion. The indication for repetition was ongoing or new-onset diarrhoea (≥3 loose or liquid stools per day), as judged by a trial physician, without new testing for C difficile. We used a different donor when repeating FMTs.

    Arm title
    		 Rectal bacteriotherapy (RBT)
    Arm description
    		 The standardised laboratory-based bacterial mixture used for rectal bacteriotherapy consisted of 12 bacterial strains suspended in 200 ml isotonic saline with concentrations of 5 × 10-10 bacteria of each strain. Included strains: Escherichia coli MT-1108-1, Escherichia coli MT-1109, Enterococcus cassiliflavus, Enterococcus gallinarum, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Clostridium bifermentans, Clostridium innocuum, Coprobacillus cateniformis, LactobacilIus rhamnosus, LactobacilIus gasserii. Participants were pretreated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 12 hours prior to RBT. RBT was administered by rectal enema with three infusions on three consecutive days for all participants in this group.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rectal bacteriotherapy
    Investigational medicinal product code
    Other name
    RBT
    Pharmaceutical forms
    Rectal suspension
    Routes of administration
    Rectal use
    Dosage and administration details
    The bacterial mixture used for rectal bacteriotherapy consisted of 12 bacterial strains suspended in 200 ml isotonic saline with concentrations of 5 × 10-10 bacteria of each strain. Included strains: Escherichia coli MT-1108-1, Escherichia coli MT-1109, Enterococcus cassiliflavus, Enterococcus gallinarum, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Clostridium bifermentans, Clostridium innocuum, Coprobacillus cateniformis, LactobacilIus rhamnosus, LactobacilIus gasserii. RBT was administered by rectal enema with three infusions on three consecutive days for all participants in this group.

    Arm title
    		 Oral vancomycin (control)
    Arm description
    		 All participants in the vancomycin group received monotherapy with oral capsule vancomycin 125 mg four times daily for 14 days. Furthermore, participants with ≥2 recurrences of CDI were treated with additionally 5 weeks of tapering as recommended in guidelines. The tapering regimen included oral vancomycin 125 mg twice daily for 1 week, 125 mg once daily for 1 week, 125 mg every other day for 1 week and 125 mg every third day for 2 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomcyin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    All participants in the vancomycin group received monotherapy with oral capsule vancomycin 125 mg four times daily for 14 days. Furthermore, participants with ≥2 recurrences of CDI were treated with additionally 5 weeks of tapering as recommended in guidelines. The tapering regimen included oral vancomycin 125 mg twice daily for 1 week, 125 mg once daily for 1 week, 125 mg every other day for 1 week and 125 mg every third day for 2 weeks.

    Number of subjects in period 1
    		Faecal microbiota transplantation (FMT) Rectal bacteriotherapy (RBT) Oral vancomycin (control)
    Started
    34
    33
    31
    Completed
    34
    31
    31
    Not completed
    0
    2
    0
         Consent withdrawn by subject
    -
    1
    -
         Concomitant non-C difficile-related disease
    -
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Faecal microbiota transplantation (FMT)
    Reporting group description
    		 Participants were pre-treated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 36 hours prior to FMT. Frozen donor stool from a donor stool bank was administered by rectal enema once, but with a possibility to repeat it up to two times within 14 days after the first infusion. The indication for repetition was ongoing or new-onset diarrhoea (≥3 loose or liquid stools per day), as judged by a trial physician, without new testing for C difficile. We used a different donor when repeating FMTs.

    Reporting group title
    Rectal bacteriotherapy (RBT)
    Reporting group description
    		 The standardised laboratory-based bacterial mixture used for rectal bacteriotherapy consisted of 12 bacterial strains suspended in 200 ml isotonic saline with concentrations of 5 × 10-10 bacteria of each strain. Included strains: Escherichia coli MT-1108-1, Escherichia coli MT-1109, Enterococcus cassiliflavus, Enterococcus gallinarum, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Clostridium bifermentans, Clostridium innocuum, Coprobacillus cateniformis, LactobacilIus rhamnosus, LactobacilIus gasserii. Participants were pretreated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 12 hours prior to RBT. RBT was administered by rectal enema with three infusions on three consecutive days for all participants in this group.

    Reporting group title
    Oral vancomycin (control)
    Reporting group description
    		 All participants in the vancomycin group received monotherapy with oral capsule vancomycin 125 mg four times daily for 14 days. Furthermore, participants with ≥2 recurrences of CDI were treated with additionally 5 weeks of tapering as recommended in guidelines. The tapering regimen included oral vancomycin 125 mg twice daily for 1 week, 125 mg once daily for 1 week, 125 mg every other day for 1 week and 125 mg every third day for 2 weeks.

    Reporting group values
    		 Faecal microbiota transplantation (FMT) Rectal bacteriotherapy (RBT) Oral vancomycin (control) Total
    Number of subjects
    		 34 33 31 98
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        median (full range (min-max))
    		 75 (47 to 96) 67 (36 to 87) 76 (33 to 94) -
    Gender categorical
    Units: Subjects
        Female
    		 20 19 14 53
        Male
    		 14 14 17 45
    Toxin profile
    Units: Subjects
        Only toxine B (and A)
    		 23 20 15 58
        Both binary toxin and toxine B (and A)
    		 9 10 14 33
        CD027 (incl. toxine B, A and binary toxin)
    		 2 3 2 7
    Hospital admission at inclusion
    Units: Subjects
        Admitted
    		 6 7 7 20
        Not admitted
    		 28 26 24 78
    Number of recurrences of CDI
    Units: number
        median (full range (min-max))
    		 1 (1 to 6) 1 (1 to 4) 1 (1 to 5) -
    Charlson Comorbidity Index
    Units: NA
        median (full range (min-max))
    		 2 (0 to 7) 2 (0 to 6) 2 (0 to 6) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Faecal microbiota transplantation (FMT)
    Reporting group description
    		 Participants were pre-treated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 36 hours prior to FMT. Frozen donor stool from a donor stool bank was administered by rectal enema once, but with a possibility to repeat it up to two times within 14 days after the first infusion. The indication for repetition was ongoing or new-onset diarrhoea (≥3 loose or liquid stools per day), as judged by a trial physician, without new testing for C difficile. We used a different donor when repeating FMTs.

    Reporting group title
    Rectal bacteriotherapy (RBT)
    Reporting group description
    		 The standardised laboratory-based bacterial mixture used for rectal bacteriotherapy consisted of 12 bacterial strains suspended in 200 ml isotonic saline with concentrations of 5 × 10-10 bacteria of each strain. Included strains: Escherichia coli MT-1108-1, Escherichia coli MT-1109, Enterococcus cassiliflavus, Enterococcus gallinarum, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Clostridium bifermentans, Clostridium innocuum, Coprobacillus cateniformis, LactobacilIus rhamnosus, LactobacilIus gasserii. Participants were pretreated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 12 hours prior to RBT. RBT was administered by rectal enema with three infusions on three consecutive days for all participants in this group.

    Reporting group title
    Oral vancomycin (control)
    Reporting group description
    		 All participants in the vancomycin group received monotherapy with oral capsule vancomycin 125 mg four times daily for 14 days. Furthermore, participants with ≥2 recurrences of CDI were treated with additionally 5 weeks of tapering as recommended in guidelines. The tapering regimen included oral vancomycin 125 mg twice daily for 1 week, 125 mg once daily for 1 week, 125 mg every other day for 1 week and 125 mg every third day for 2 weeks.

    Primary: Clinical cure within 90 days

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    End point title
    		 Clinical cure within 90 days
    End point description
    Clinical cure was defined as absence of C. difficile infection (i.e. absence of diarrhoea or diarrhoea with a negative C difficile test), within 90 days after ended treatment.
    End point type
    Primary
    End point timeframe
    Within 90 days after ended treatment
    End point values
    		 Faecal microbiota transplantation (FMT) Rectal bacteriotherapy (RBT) Oral vancomycin (control)
    Number of subjects analysed
    34
    31
    31
    Units: Number
        Clinical cure
    26
    16
    14
    Attachments
    		 Clinical cure rate
    Statistical analysis title
    		 Comparison of primary end point
    Comparison groups
    Faecal microbiota transplantation (FMT) v Rectal bacteriotherapy (RBT) v Oral vancomycin (control)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25
         upper limit
    		 75

    Secondary: 180-day mortality

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    End point title
    		 180-day mortality
    End point description
    All-cause mortality
    End point type
    Secondary
    End point timeframe
    180 days after ended treatment
    End point values
    		 Faecal microbiota transplantation (FMT) Rectal bacteriotherapy (RBT) Oral vancomycin (control)
    Number of subjects analysed
    34
    31
    31
    Units: Number
        Dead of all-causes at 180-days follow-up
    2
    4
    7
    Attachments
    		 All-cause mortality at 180-days follow-up
    Statistical analysis title
    		 Odds ratio
    Comparison groups
    Faecal microbiota transplantation (FMT) v Rectal bacteriotherapy (RBT) v Oral vancomycin (control)
    Number of subjects included in analysis
    96
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Odds ratio (OR)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25
         upper limit
    		 75

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From inclusion to 14 days after ended treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NA
    Dictionary version
    NA
    Reporting groups
    Reporting group title
    Faecal microbiota transplantation (FMT)
    Reporting group description
    		 Participants were pre-treated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 36 hours prior to FMT. Frozen donor stool from a donor stool bank was administered by rectal enema once, but with a possibility to repeat it up to two times within 14 days after the first infusion. The indication for repetition was ongoing or new-onset diarrhoea (≥3 loose or liquid stools per day), as judged by a trial physician, without new testing for C difficile. We used a different donor when repeating FMTs.

    Reporting group title
    Rectal bacteriotherapy (RBT)
    Reporting group description
    		 The standardised laboratory-based bacterial mixture used for rectal bacteriotherapy consisted of 12 bacterial strains suspended in 200 ml isotonic saline with concentrations of 5 × 10-10 bacteria of each strain. Included strains: Escherichia coli MT-1108-1, Escherichia coli MT-1109, Enterococcus cassiliflavus, Enterococcus gallinarum, Bacteroides thetaiotaomicron, Bacteroides ovatus, Bacteroides vulgatus, Clostridium bifermentans, Clostridium innocuum, Coprobacillus cateniformis, LactobacilIus rhamnosus, LactobacilIus gasserii. Participants were pretreated with oral vancomycin 125 mg four times a day for 7-14 days. This was discontinued 12 hours prior to RBT. RBT was administered by rectal enema with three infusions on three consecutive days for all participants in this group.

    Reporting group title
    Oral vancomycin (control)
    Reporting group description
    		 All participants in the vancomycin group received monotherapy with oral capsule vancomycin 125 mg four times daily for 14 days. Furthermore, participants with ≥2 recurrences of CDI were treated with additionally 5 weeks of tapering as recommended in guidelines. The tapering regimen included oral vancomycin 125 mg twice daily for 1 week, 125 mg once daily for 1 week, 125 mg every other day for 1 week and 125 mg every third day for 2 weeks.

    Serious adverse events
    		 Faecal microbiota transplantation (FMT) Rectal bacteriotherapy (RBT) Oral vancomycin (control)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 34 (2.94%)
    3 / 31 (9.68%)
    6 / 31 (19.35%)
         number of deaths (all causes)
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Cardiac disorders
    Chest pain
    Additional description: Unknown cause
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Syncope
    Additional description: Syncope leading to a car crash, happening after hemodialysis
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subdural haematoma
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Dizziness
    Additional description: Severe, leading to hospitalization. Occurred before FMT, during pre-treatment with oral vancomycin.
         subjects affected / exposed
    1 / 34 (2.94%)
    0 / 31 (0.00%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Oedema
    Additional description: Oedema, dyspnoea and fever
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Death
    Additional description: Of unknown cause - the participant had anaemia and a possible insufficiently treated e.coli bacteriaemia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Urosepsis
         subjects affected / exposed
    0 / 34 (0.00%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Faecal microbiota transplantation (FMT) Rectal bacteriotherapy (RBT) Oral vancomycin (control)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    32 / 34 (94.12%)
    29 / 31 (93.55%)
    21 / 31 (67.74%)
    General disorders and administration site conditions
    Fever or feeling feverish after treatment
         subjects affected / exposed
    3 / 34 (8.82%)
    3 / 31 (9.68%)
    0 / 31 (0.00%)
         occurrences all number
    3
    3
    0
    Dizziness during treatment
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Hypotension during treatment
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Defecation urge during procedure
         subjects affected / exposed
    20 / 34 (58.82%)
    5 / 31 (16.13%)
    0 / 31 (0.00%)
         occurrences all number
    20
    5
    0
    Abdominal pain or discomfort during procedure or active treatment
         subjects affected / exposed
    15 / 34 (44.12%)
    1 / 31 (3.23%)
    2 / 31 (6.45%)
         occurrences all number
    15
    1
    2
    Faecal incontinence during procedure
         subjects affected / exposed
    8 / 34 (23.53%)
    3 / 31 (9.68%)
    0 / 31 (0.00%)
         occurrences all number
    8
    3
    0
    Borborygmi during procedure
         subjects affected / exposed
    7 / 34 (20.59%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    7
    1
    0
    Nausea or vomiting during procedure or active treatment
         subjects affected / exposed
    5 / 34 (14.71%)
    0 / 31 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    5
    0
    3
    Bloating after treatment
         subjects affected / exposed
    14 / 34 (41.18%)
    19 / 31 (61.29%)
    0 / 31 (0.00%)
         occurrences all number
    14
    19
    0
    Abdominal pain or discomfort after treatment
         subjects affected / exposed
    17 / 34 (50.00%)
    24 / 31 (77.42%)
    2 / 31 (6.45%)
         occurrences all number
    17
    24
    2
    Flatulence after treatment
         subjects affected / exposed
    7 / 34 (20.59%)
    3 / 31 (9.68%)
    0 / 31 (0.00%)
         occurrences all number
    7
    3
    0
    Diarrhoae after treatment
         subjects affected / exposed
    10 / 34 (29.41%)
    22 / 31 (70.97%)
    3 / 31 (9.68%)
         occurrences all number
    10
    22
    3
    Borborygmi after treatment
         subjects affected / exposed
    4 / 34 (11.76%)
    10 / 31 (32.26%)
    0 / 31 (0.00%)
         occurrences all number
    4
    10
    0
    Nausea or vomiting after treatment
         subjects affected / exposed
    4 / 34 (11.76%)
    5 / 31 (16.13%)
    0 / 31 (0.00%)
         occurrences all number
    4
    5
    0
    Bloating during treatment
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    2 / 31 (6.45%)
         occurrences all number
    0
    0
    2
    Loss of appetite
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    0
    3
    Constipation
         subjects affected / exposed
    4 / 34 (11.76%)
    2 / 31 (6.45%)
    1 / 31 (3.23%)
         occurrences all number
    4
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea during treatment
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    1 / 31 (3.23%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Itching or rash during treatment
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 31 (0.00%)
    3 / 31 (9.68%)
         occurrences all number
    0
    0
    3
    Infections and infestations
    Urinary tract infections
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 31 (3.23%)
    0 / 31 (0.00%)
         occurrences all number
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    A interim analysis was performed for the first 90 participants. When the reported results were apparent, including the mortality data, the study was terminated due to futility and ethical concerns—even though the Haybittle-Peto boundary was not met

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/33694229
    http://www.ncbi.nlm.nih.gov/pubmed/31273647
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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