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    Clinical Trial Results:
    Open, randomized clinical trial to evaluate the treatment of First Clostridium difficile infection episodes with bacteriotherapy

    Summary
    EudraCT number
    		 2017-003147-38
    Trial protocol
    		 ES  
    Global end of trial date
    30 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Feb 2026
    First version publication date
    07 Feb 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MICRO.HGUGM.2017-14
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto de Investigación Biosanitaria del Hospital Gregorio Marañón
    Sponsor organisation address
    c/Doctor Esquerdo 46, Madrid, Spain,
    Public contact
    Elena Reigadas, Instituto de Investigación Biosanitaria del Hospital Gregorio Marañón. Emilio Bouza Santiago, 34 915868453, helenrei@hotmail.com
    Scientific contact
    Elena Reigadas, Instituto de Investigación Biosanitaria del Hospital Gregorio Marañón. Emilio Bouza Santiago, 34 915868453, helenrei@hotmail.com
    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
    30 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jan 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the recurrence rate to treatment with bacteriotherapy versus conventional treatment with vancomycin
    Protection of trial subjects
    Investigators: Ensure ethical conduct, obtain consent, provide care, and report deviations. Sponsors: Provide insurance/indemnity, oversee quality, and ensure compliant trial conduct. Key Protections & Principles Informed Consent Prioritization Independent Oversight Privacy & Confidentiality Medical Care Risk/Benefit Assessment Data Integrity
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Dec 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
    Spain: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    11
    From 65 to 84 years
    24
    85 years and over
    13

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment of patients attended in HGUGM, Madrid, Spain.

    Pre-assignment
    Screening details
    		 Inclusion Criteria: • Men and Women • Age >18 years • Agree and be able to provide informed consent (patient or legal representative). • Microbiologically confirmed diagnosis of toxigenic Clostridium difficile infection (CDI) with a positive direct toxin test and diarrhea (>3 bowel movements/24 hours) or colonoscopic or histopathologica

    Pre-assignment period milestones
    Number of subjects started
    		 48
    Number of subjects completed
    		 48

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Bacteriotherapy (Fecal Microbiota Transplant)
    Arm description
    		 Bacteriotherapy (Fecal Transplant). Bacteriotherapy is administered according to the following regimen: • A single administration of 4 capsules. Each capsule contains 0.20 +/- 0.03 g of lyophilized fecal matter, equivalent to 2.1-2.5 x 10¹¹ bacterial cells.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bacteriotherapy (fecal microbiota transplant)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    Bacteriotherapy (Fecal Transplant). Bacteriotherapy is administered according to the following regimen: • A single administration of 4 capsules. Each capsule contains 0.20 +/- 0.03 g of lyophilized fecal matter, equivalent to 2.1-2.5 x 10¹¹ bacterial cells.

    Arm title
    		 Vancomycin 125mg/6 h 10 days
    Arm description
    		 Standard treatment Vancomycin 125mg/6 hours for 10 days
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Vancomycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for oral solution
    Routes of administration
    Gastroenteral use
    Dosage and administration details
    oral vancomycin 125mg/6 hours for 10 days

    Number of subjects in period 1
    		Bacteriotherapy (Fecal Microbiota Transplant) Vancomycin 125mg/6 h 10 days
    Started
    24
    24
    Completed
    21
    23
    Not completed
    3
    1
         Physician decision
    2
    -
         Adverse event, non-fatal
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Bacteriotherapy (Fecal Microbiota Transplant)
    Reporting group description
    		 Bacteriotherapy (Fecal Transplant). Bacteriotherapy is administered according to the following regimen: • A single administration of 4 capsules. Each capsule contains 0.20 +/- 0.03 g of lyophilized fecal matter, equivalent to 2.1-2.5 x 10¹¹ bacterial cells.

    Reporting group title
    Vancomycin 125mg/6 h 10 days
    Reporting group description
    		 Standard treatment Vancomycin 125mg/6 hours for 10 days

    Reporting group values
    		 Bacteriotherapy (Fecal Microbiota Transplant) Vancomycin 125mg/6 h 10 days Total
    Number of subjects
    		 24 24 48
    Age categorical
    years
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 5 6 11
        From 65-84 years
    		 12 12 24
        85 years and over
    		 7 6 13
    Gender categorical
    Units: Subjects
        Female
    		 17 20 37
        Male
    		 7 4 11

    End points

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    End points reporting groups
    Reporting group title
    Bacteriotherapy (Fecal Microbiota Transplant)
    Reporting group description
    		 Bacteriotherapy (Fecal Transplant). Bacteriotherapy is administered according to the following regimen: • A single administration of 4 capsules. Each capsule contains 0.20 +/- 0.03 g of lyophilized fecal matter, equivalent to 2.1-2.5 x 10¹¹ bacterial cells.

    Reporting group title
    Vancomycin 125mg/6 h 10 days
    Reporting group description
    		 Standard treatment Vancomycin 125mg/6 hours for 10 days

    Primary: Overall Evolution

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    End point title
    		 Overall Evolution
    End point description
    The primary variable will be the patient's evolution, classified as positive resolution or poor evolution. Poor evolution includes any of the following: treatment failure; progression of the infection to severe or complicated forms; recurrence; or mortality associated with the infection.
    End point type
    Primary
    End point timeframe
    60 days after treatment
    End point values
    		 Bacteriotherapy (Fecal Microbiota Transplant) Vancomycin 125mg/6 h 10 days
    Number of subjects analysed
    21
    23
    Units: Total individuals for each categoru
        Poor evolution
    5
    7
        Complete Resolution
    16
    16
    Statistical analysis title
    		 Comparison Bacteriotherapy vs Standard treatment
    Statistical analysis description
    The comparison of recurrence rates between groups will be performed using the Fisher's exact test, estimating relative risk, absolute risk difference, and 95% confidence intervals.
    Comparison groups
    Bacteriotherapy (Fecal Microbiota Transplant) v Vancomycin 125mg/6 h 10 days
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.7403 [1]
    Method
    		 Fisher exact
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.57
    Variability estimate
    Standard deviation
    Dispersion value
    0.1841
    Notes
    [1] - Bacteriotherapy did not show to be superior to standard treatment for CDI first episodes, the difference was not statistically significant. The sample size was small and did not reach the number of patients sufficient to demonstrate superiority.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    90 days after enrolment
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24
    Reporting groups
    Reporting group title
    Bacteriotherapy (Fecal Microbiota Transplant)
    Reporting group description
    		 Bacteriotherapy (Fecal Transplant). Bacteriotherapy is administered according to the following regimen: • A single administration of 4 capsules. Each capsule contains 0.20 +/- 0.03 g of lyophilized fecal matter, equivalent to 2.1-2.5 x 10¹¹ bacterial cells.

    Reporting group title
    Vancomycin 125mg/6 h 10 days
    Reporting group description
    		 Standard treatment Vancomycin 125mg/6 hours for 10 days

    Serious adverse events
    		 Bacteriotherapy (Fecal Microbiota Transplant) Vancomycin 125mg/6 h 10 days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 24 (45.83%)
    10 / 24 (41.67%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    Vascular disorders
    Cerebral artery occlusion
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardio-respiratory arrest
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac failure
         subjects affected / exposed
    2 / 24 (8.33%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiogenic shock
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Confusional state
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Clostridium difficile infection
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 24 (8.33%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin ulcer
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal impairment
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    sepsis
    Additional description: sepsis of urinary tract origin
         subjects affected / exposed
    1 / 24 (4.17%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Bacteriotherapy (Fecal Microbiota Transplant) Vancomycin 125mg/6 h 10 days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 24 (16.67%)
    2 / 24 (8.33%)
    Vascular disorders
    Syncope
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Clostridium difficile infection
         subjects affected / exposed
    2 / 24 (8.33%)
    2 / 24 (8.33%)
         occurrences all number
    2
    3
    Campylobacter gastroenteritis
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    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.
    None reported
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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