PPI-Washout Study
Research type
Research Study
Full title
The use of Antacids and Alginates during Pre-Investigation Proton Pump Inhibitor Washout: Impact on Compliance and Symptom Burden
IRAS ID
273672
Contact name
Philip Woodland
Sponsor organisation
The Functional Gut Clinic
Eudract number
2019-004561-41
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
Research Summary
The movement of stomach contents to the food pipe, known as gastro-oesophageal reflux, affects 10-30% of the world population causing symptoms such as heartburn. A group of medicines, known as Proton Pump Inhibitors (PPIs), are the most effective way to stop acid secretion in the stomach and are frequently prescribed as a first line treatment by doctors. However, there are situations where further assessment with an endoscopy or 24-hour reflux test is needed. Usually this means stopping the PPIs to measure the reflux in normal conditions.
During this time patients can suffer distressing symptoms which can affect the test results. At the moment, during this pre-investigation period, patients are simply told which medicines to stop and when. There is no specific advice about what can be done to reduce their symptoms.
PPIs affect acid producing cells in the stomach and must be stopped for 1 week before any investigation. This allows the cells to recover and produce an accurate reading of the patient’s normal acid levels. Alginates such as Gaviscon Advance don’t affect acid cells, but have a “raft-forming” property, coating the food pipe and protecting it from acid. As they don’t directly affect acid production, they can be taken up until the night before the test. Some patients that have previously only been taking PPIs would not instinctively use an alginate during the pre-investigation period.
Our study intends to recruit 60 patients who are attending The Functional Gut Clinic for reflux testing. Half will be given the usual advice of when to stop their medication, and the other given specific advice on how to use Gaviscon Advance. The patients will be asked to fill in a questionnaire about their symptoms, but their usual care will not be affected. We plan to complete the study in 8 months.Summary of Results
Publication: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbbchXWYv-2Fy-2Bjpay06PoRmCZpJD0b2D4k-2F-2BMYGefS1GCVflCm7qJwkjR7d44WfsLfHg-3D-3D_O3h_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL6jKydSWtP-2B4hZFr4qlsSDf1RLzU-2FLSkDf39MwFkI2Kk1lhHHabk18hBrJdHiM37wsDfTZ63T-2F7nw-2BwI-2FOwQxo7B-2FtDXVFh-2F84bZ3gc7BdkTgIRSSOy6rhABCyRS6ljIOTSoP4-2FZFmlHCoOOcOc3WxNEbXEQsHbVfvVryYyN-2ByhQ-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7C78b749791e894d9affac08dbdae030a4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638344428638366634%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=dvUvAyEbnhytLi%2Ba%2FAuy9nh%2BJNTov%2FvPJt%2Bsk2WIyAw%3D&reserved=0
Many thanks for participating in our research study. Your involvement was invaluable and has contributed to the research of acid reflux. It was published in the medical journal “BMJ Open Gastroenterology” and will hopefully be of benefit to thousands of patients nationwide.
The study took place at The Functional Gut Clinic in central London. It was designed to help people who have to stop certain medicines before being investigated for acid reflux. Many people with reflux take a certain type of antacid medicine called proton pump inhibitors or “PPIs”. However, most of the time these need to be stopped a week before testing for reflux. This can cause rebound symptoms and lead to a lot of discomfort. Our research study was designed to see if there is a better way of stopping PPIs.
Participants were selected because they attended our clinic for reflux testing. Half of them were randomly selected to follow the normal instructions. The other half followed the normal instructions but were also given a bottle of Gaviscon Advance and asked to take it proactively four times a day.
The results showed that those that followed just the normal instructions got worse symptoms after stopping their PPIs. In contrast, those taking the Gaviscon Advance proactively did not experience worse symptoms.
This has helped research as now we can advise clinics nationwide that they should change their instructions. It should now tell patients to take Gaviscon Advance proactively when they stop PPIs.
The information has been published in the Association of Gastrointestinal Physiologist newsletter which is distributed to reflux testing centres nationwide. The study was also published in a national medical journal “BMJ Open Gastroenterology”.
The full details and results can be found online at the publication link https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbbchXWYv-2Fy-2Bjpay06PoRmCZpJD0b2D4k-2F-2BMYGefS1GCVflCm7qJwkjR7d44WfsLfHg-3D-3DXw1R_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL6jKydSWtP-2B4hZFr4qlsSD9yEPpq54Andbp8gsdjbaPH3vAfAihGLZw8ca9eiN9nSl-2BiwI2-2FEKmDmZetNrMZyHdM3j-2BDf1iCwnjPyevHYeKzGyw4dnWap5ZD9Sg8DtFrgNDwBekVCaIU7z7KOARAD58jb7qlDkIuLc0-2BkuARRnOw-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7C78b749791e894d9affac08dbdae030a4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638344428638366634%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=RQmG7NQtvBUdX5%2FjoAb4wL7n15Cw2XoCPQZySviKKl4%3D&reserved=0
Many thanks again for all your help.Has the registry been updated to include summary results?: Yes
If yes - please enter the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfatiYvtk1-2B2gi1K6vKImual9G6VG4-2FeFhNKGHEnJKTVSjoOigpnn86W613BTxFvKmaOKrC4u7T3-2FME8v4-2BsOZyR9PLx_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL6jKydSWtP-2B4hZFr4qlsSDoWDVZbkGsWGwkqyVfnqHdeOoesth0BsYbbvzcC-2BjjiK-2FFjRE5oRjdc-2BYXUVQ67RcS-2B-2BoK78ZDurDLsx74-2F-2BPsbSO-2BGkOVPlLQxJda32vk8cE5jwqSl79g1yA4VW8GYT83ymGZR0i9YcZOB43cSPDtw-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7C78b749791e894d9affac08dbdae030a4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638344428638522850%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=KnKdTiAyTyv5JIGdFlpfgNN9%2Fy%2FD0RySnpqicpZV1N8%3D&reserved=0
If no – why not?:
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbbchXWYv-2Fy-2Bjpay06PoRmCZpJD0b2D4k-2F-2BMYGefS1GCVflCm7qJwkjR7d44WfsLfHg-3D-3D6fDk_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YL6jKydSWtP-2B4hZFr4qlsSDVcv1JGaA0RUWc84n-2BrvFsxa2AcK2gd5AwQF9ay-2Btm-2BNXx7wlkcPWE-2BX1YhpsMQGZKcHa4uvi1N4OCgPT26khR14AS57pdO38pKNu9V1Cj9dnzdljzXesUYHBD8edhE5kGzNV95KxCw3XqcCiHtFYoA-3D-3D&data=05%7C01%7Csurreyborders.rec%40hra.nhs.uk%7C78b749791e894d9affac08dbdae030a4%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638344428638522850%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=21%2FjvlHXgQNFr9iZ7jMPMz7UacnBqQXFz2ga%2F9mVmLc%3D&reserved=0
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Pending
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected: 01/12/2023
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: The study has been published by a national journal. In the publication we have provided an email and selected the option that the data can be shared if requested but only after ethical and anonymisation processes have been followed.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: No tissue samples taken.REC name
London - Surrey Borders Research Ethics Committee
REC reference
20/LO/0042
Date of REC Opinion
14 Feb 2020
REC opinion
Further Information Favourable Opinion