Status:
COMPLETED
Intestinal Adsorbent and Breath Gas Levels
Lead Sponsor:
Dr Anthony Hobson
Conditions:
Gastroesophageal Reflux
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
Participants will be recruited either through clinics at the functional gut clinic or through interest shown to advertising for the study. If the patient is deemed eligible they will be given atleast ...
Eligibility Criteria
Inclusion
- 1\. 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.
- 2\. 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.
- 7\. Participant has capacity to understand written English 8. Participant agrees to follow pre-test diet for 24 hours before giving test sample (Appendix A).
- 9\. Participant agrees to refrain from strenuous physical activity on the day of the breath test.
- 10\. 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.
- 12\. Participant agrees to not take any probiotic for 7 days before the breath test.
- 13\. Participant has a body mass index (BMI) between 18.5 and 34.9kg/m2 (bounds included).
Exclusion
- 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
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04492839
Start Date
August 13 2019
End Date
December 1 2020
Last Update
April 27 2022
Active Locations (1)
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1
The Functional Gut Clinic
Manchester, United Kingdom, M2 4NG