Intestinal Adsorbent and Breath Gas Levels

NCT04492839 | Completed

• 1 other identifier: FGC-19-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of an intestinal adsorbent on hydrogen and methane breath levels in patients who have been on long term PPI therapy reporting reflux and abdominal symptoms at baseline.

Conditions

Gastroesophageal Reflux; Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (1)

• To determine the effect of Silicolgel on hydrogen and methane breath levels in patients who have been on long term PPI therapy reporting reflux and abdominal symptoms at baseline.

  Hydrogen and methane breath testing will be used to take readings of participants breath gas levels (hydrogen and methane) as a measure of microbial fermentation. Mean change in cumulative total breath hydrogen and methane, will be determined from baseline HMBT to end of study HMBT. Cumulative total hydrogen and cumulative total methane will be calculated independently of one each other. Breath hydrogen and breath methane will be measured in units of parts per million (ppm). Statistical significance will be determined using a paired t-test (p\<0.05). Each HMBT samples will be analysed using gas chromatography analysis on the day of the breath test being carried out. Breath carbon dioxide will also be measured in order to verify the validity of each sample and apply a correction factor. A correction factor above 2.5 (CO2 \< 2%) is considered an invalid sample.

  18 months

Secondary Outcomes (2)

• To determine the effect of Silicolgel on abdominal symptoms in patients who have been on long term PPI therapy reporting reflux and abdominal symptoms at baseline.

  18 months

• To determine the effect of Silicolgel on reflux symptoms in patients who have been on long term PPI therapy reporting reflux and abdominal symptoms at baseline.

  18 months

Study Arms (1)

Intestial adsorbent arm

EXPERIMENTAL

This is a single arm study, all participants will receive the class IIa intestinal adsorbent medical device

Device: Intestinal adsorbent

Interventions

Intestinal adsorbent DEVICE

Participants will consume the 15ml of the intestinal adsorbent (3.5 g Silicon dioxide in 100 ml Silicic acid gel, Preservatives: Sorbic acid (E 200), Sodium benzoate (E 211). ) three times daily for 10 days. There are no known side effects of the medical device. The product is a class IIa medical device under the European council directive and the product will be used within it's current indications.

Intestial adsorbent arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Participant has provided written informed consent before participating in the study after being given a full description of the study and prior to any study-specific procedures being performed.
• \. Patient has been taking PPI therapy for \>6 months 3. Patient reports bloating ≥3 on screening questionnaire 4. Patient reports one of the following ≥3 on screening questionnaire - belching, heartburn, nausea, reflux sensation 5. Participant is a male or non-pregnant female and is age 18 years of age or above 6. Participant is able to communicate well with the Investigator and to comply with the requirements for the entire study.
• \. Participant has capacity to understand written English 8. Participant agrees to follow pre-test diet for 24 hours before giving test sample (Appendix A).
• \. Participant agrees to refrain from strenuous physical activity on the day of the breath test.
• \. Participant agrees to refrain from smoking on the day of the breath test 11. Participant agrees to an overnight fast on the night before the breath test. Food and drink must be withheld until after all breath test samples have been taken.
• \. Participant agrees to not take any probiotic for 7 days before the breath test.
• \. Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).

You may not qualify if:

• Participant reports using any prohibited medication, medical device or supplementation
• Participant has taken antibiotics or undergone colonoscopy/sigmoidoscopy in the 4 weeks prior to enrolment.
• Participant has a diagnosis of any organic gastrointestinal disease, including inflammatory bowel disease, coeliac disease and diverticulitis.
• Participant has known mechanical obstruction of the GI tract
• Participant has diabetes
• Participant has any hepatic disease
• Participant has any disease of the CNS
• Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.
• Participant has had previous abdominal or colorectal surgery except appendectomy, cholecystectomy, or hysterectomy.
• Participant has previously taken Silicolgel in the past month
• Participant has a known hypersensitivity to any of the ingredients of Silicolgel
• Participant suffers regularly from constipation
• Participant is involved in any other research projects either currently or during the previous month

Sponsors & Collaborators

• Dr Anthony Hobson: lead

Study Sites (1)

The Functional Gut Clinic

Manchester, M2 4NG, United Kingdom

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Anthony Hobson, PhD

  Clinical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants will be masked to the name of the product, but will be informed it is an intestinal adsorbent, class IIa medical device, available to buy over the counter.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 30, 2020
• Study Start: August 13, 2019
• Primary Completion: October 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)