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    Clinical Trial Results:
    The use of Antacids and Alginates during Pre-Investigation Proton Pump Inhibitor Washout: Impact on Compliance and Symptom Burden

    Summary
    EudraCT number
    		 2019-004561-41
    Trial protocol
    		 GB  
    Global end of trial date
    05 Jul 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Dec 2022
    First version publication date
    15 Dec 2022
    Other versions
    Summary report(s)
    		 PPI Washout Study Abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    FGC-19-003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Functional Gut Clinic
    Sponsor organisation address
    8 Dorset Square, London, United Kingdom, NW1 6PU
    Public contact
    Andres Vales, The Functional Gut Clinic, 0044 204867777, andres@thefunctionalgutclinic.com
    Scientific contact
    Andres Vales, The Functional Gut Clinic, 0044 204867777, andres@thefunctionalgutclinic.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
    05 Jul 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The Gastro-Esophageal Reflux Disease Health Related Quality of Life (GERD-HRQL) (1) score is a validated questionnaire and is commonly used in reflux studies. We will use this questionnaire to ask how patients tolerate stopping their acid reducing medications before reflux testing. We will use this to see if giving them specific instruction about how to use Gaviscon Advance helps patients to tolerate better, versus simply giving them the plain information and allowing them to do it themselves. (1) Velanovich, V. The development of the GERD-HRQL symptom severity instrument. Diseases of the Esophagus. Volume 20, Issue 2, P130-134. April 2007.
    Protection of trial subjects
    The trial site was a clinic with experience in performing gastrointestinal diagnostic tests. Clinicians performing the test are experienced in making the patient feel comfortable and reassured and are HCPC registered. The clinic is inspected in terms of the site and patient pathway every year by the CQC. The clinic is also IQIPS accredited with a yearly thorough inspection of clinical governance and patient dignity etc.
    Background therapy
    		 All patients were asked to follow the "standard information", that is, to stop proton pump inhibitors and H2 receptor antagonists, as per British Society of Gastroenterology guidelines for performing 24 hour pH monitoring.
    Evidence for comparator
    		 Patients were allowed to take over the counter remedies for symptoms of acid reflux and indigestion, aside from those they were asked to stop. There were able to take them up to the night before the test but not during the test. These types of treatments are found not to affect test accuracy as long as they are not taken immediately before the test - Gatta L, Vakil N, Ricci C, Osborn JF, Tampieri A, Perna F, et al. Effect of proton pump inhibitors and antacid therapy on 13C urea breath tests and stool test for Helicobacter pylori infection. Am J Gastroenterol. 2004;99(5):823-9.
    Actual start date of recruitment
    10 Aug 2020
    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
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    0
    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)
    53
    From 65 to 84 years
    7
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants ≥18 years old were selected from those referred for oesophageal manometry and 24-hour pH/impedance monitoring at The Functional Gut Clinic. When booking in, patients already established on a ≥four-week course of standard or double dose PPI therapy were given information about the study. Recruitment occurred between Aug '20 and June '21

    Pre-assignment
    Screening details
    		 Prospective participants were screened over the phone and those with red flag symptoms, known Barrett’s oesophagus, grade C/D oesophagitis, peptic ulcer disease, upper gastrointestinal malignancy or those with previous oesophageal or gastric surgery were excluded. Those with allergies to alginates/antacids or on a low salt diet were also excluded.

    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
    		 Control Group
    Arm description
    		 Everyone was given the usual information regarding the washout period, namely stopping proton pump inhibitors and H2 Receptor Antagonists for seven days and advised that antacids/alginates could be taken up to the night before the test.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment Group
    Arm description
    		 The treatment group only were given a bottle of Gaviscon Advance (oral suspension, containing 1000 mg sodium alginate and 200 mg potassium bicarbonate per 10 mL dose). They were asked to take 10 mL of suspension, four times a day (after breakfast, lunch, dinner and before bed) from when PPIs were stopped until the night before testing.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Gaviscon Advance
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    1000 mg sodium alginate and 200 mg potassium bicarbonate per 10 mL dose

    Number of subjects in period 1
    		Control Group Treatment Group
    Started
    30
    30
    Completed
    26
    22
    Not completed
    4
    8
         Lost to follow-up
    4
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Everyone was given the usual information regarding the washout period, namely stopping proton pump inhibitors and H2 Receptor Antagonists for seven days and advised that antacids/alginates could be taken up to the night before the test.

    Reporting group title
    Treatment Group
    Reporting group description
    		 The treatment group only were given a bottle of Gaviscon Advance (oral suspension, containing 1000 mg sodium alginate and 200 mg potassium bicarbonate per 10 mL dose). They were asked to take 10 mL of suspension, four times a day (after breakfast, lunch, dinner and before bed) from when PPIs were stopped until the night before testing.

    Reporting group values
    		 Control Group Treatment Group Total
    Number of subjects
    		 30 30 60
    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 (inter-quartile range (Q1-Q3))
    		 50 (38 to 55) 46 (36 to 54) -
    Gender categorical
    Units: Subjects
        Female
    		 16 13 29
        Male
    		 14 17 31
    Subject analysis sets

    Subject analysis set title
    Control Group Day 0
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Control group for the trial on the last day of taking PPIs and time point when the baseline questionnaire data is collected.

    Subject analysis set title
    Treatment Group Day 0
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Treatment group for the trial on the last day of taking PPIs and time point when the baseline questionnaire data is collected.

    Subject analysis set title
    Control Group Day 7
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Control group for the trial 7 days after stopping PPIs and when the repeat questionnaire data is collected.

    Subject analysis set title
    Treatment Group Day 7
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Treatment group for the trial 7 days after stopping PPIs and when the repeat questionnaire data is collected.

    Subject analysis sets values
    		 Control Group Day 0 Treatment Group Day 0 Control Group Day 7 Treatment Group Day 7
    Number of subjects
    26
    22
    26
    22
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    52 (43 to 56)
    46 (36 to 54)
    Gender categorical
    Units: Subjects
        Female
    15
    9
        Male
    11
    13

    End points

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    End points reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Everyone was given the usual information regarding the washout period, namely stopping proton pump inhibitors and H2 Receptor Antagonists for seven days and advised that antacids/alginates could be taken up to the night before the test.

    Reporting group title
    Treatment Group
    Reporting group description
    		 The treatment group only were given a bottle of Gaviscon Advance (oral suspension, containing 1000 mg sodium alginate and 200 mg potassium bicarbonate per 10 mL dose). They were asked to take 10 mL of suspension, four times a day (after breakfast, lunch, dinner and before bed) from when PPIs were stopped until the night before testing.

    Subject analysis set title
    Control Group Day 0
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Control group for the trial on the last day of taking PPIs and time point when the baseline questionnaire data is collected.

    Subject analysis set title
    Treatment Group Day 0
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Treatment group for the trial on the last day of taking PPIs and time point when the baseline questionnaire data is collected.

    Subject analysis set title
    Control Group Day 7
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Control group for the trial 7 days after stopping PPIs and when the repeat questionnaire data is collected.

    Subject analysis set title
    Treatment Group Day 7
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Treatment group for the trial 7 days after stopping PPIs and when the repeat questionnaire data is collected.

    Primary: Change in GERD-HRQL score - Control Group

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    End point title
    		 Change in GERD-HRQL score - Control Group
    End point description
    Questionnaire score. Minimum score is 0 - no symptoms. Max score is 50 - worst symptoms.
    End point type
    Primary
    End point timeframe
    The GERD-HRQL score was taken on the last day of taking PPIs (Day 0). A repeat score was taken just before the 24 hour pH test (Day 7).
    End point values
    		 Control Group Day 0 Control Group Day 7
    Number of subjects analysed
    26
    26
    Units: N/A
        median (inter-quartile range (Q1-Q3))
    10 (6.3 to 21)
    16.5 (13.3 to 25.3)
    Attachments
    		 Untitled (Filename: Fig 2 - HRQL - ITT.png)
    Statistical analysis title
    		 Control Group Wilcoxon Signed Ranks Test
    Comparison groups
    Control Group Day 0 v Control Group Day 7
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Median difference (final values)
    Point estimate
    6.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 7
    Variability estimate
    Standard deviation

    Primary: Change in GERD-HRQL score - Treatment Group

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    End point title
    		 Change in GERD-HRQL score - Treatment Group
    End point description
    Questionnaire score. Minimum score is 0 - no symptoms. Max score is 50 - worst symptoms.
    End point type
    Primary
    End point timeframe
    The GERD-HRQL score was taken on the last day of taking PPIs (Day 0). A repeat score was taken just before the 24 hour pH test (Day 7).
    End point values
    		 Treatment Group Day 0 Treatment Group Day 7
    Number of subjects analysed
    22
    22
    Units: N/A
        median (inter-quartile range (Q1-Q3))
    19 (12.3 to 24.3)
    17.5 (13 to 24)
    Attachments
    		 Untitled (Filename: Fig 2 - HRQL - ITT.png)
    Statistical analysis title
    		 Treatment Group Wilcoxon Signed Ranks Test
    Statistical analysis description
    Analysis of the symptoms change from the last day of taking PPIs compared to 7 days later. The null hypothesis was that symptoms would significantly deteriorate.
    Comparison groups
    Treatment Group Day 0 v Treatment Group Day 7
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon signed-rank test
    Parameter type
    		 Median difference (final values)
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 3.5
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Less than 15 days
    Adverse event reporting additional description
    All those responsible for screening patients were instructed in the proper completion of trial documents and signed a declaration to this effect. A form for recording adverse events existed within the Site File and there was a protocol for keeping all site staff up to date with events. Overall responsibility was held by the Principal Investigator.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    2018
    Reporting groups
    Reporting group title
    Treatment Group
    Reporting group description
    		 Treatment group for the trial, as previously described.

    Serious adverse events
    		 Treatment Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 22 (4.55%)
    Product issues
    Nausea
    Additional description: The participant had a severe dislike of the taste of the product (personal preference) and were allowed to stopped taking it. But they were still included in the Intention To Treat analysis.
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    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? Yes
    Date
    Interruption
    Restart date
    01 Mar 2020
    COVID Pandemic
    10 Aug 2020

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The main limitation of our study is that, despite randomisation, the GERD-HRQL scores between the groups differ at baseline. After investigation, a subversion of the allocation procedure could not be found.
    For support, Contact us.
    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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