Intestinal Adsorbent and Breath Gas Levels

NCT ID: NCT04492839

Last Updated: 2022-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2020-12-01

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 24 hours to review the patient information sheet. If they would like to proceed with participation they will be given the chance to ask the study team any questions. If they would still like to proceed the participant will be asked to sign three copies of the informed consent form.

The participants will be required to visit the clinic twice during the study. The day before visit 1 the patient will be required to follow a low residue diet as part of preparation for the hydrogen methane breath. On the day of the first visit participants will complete a hydrogen methane breath test as per the functional gut clinics test protocol, the patient will also be asked to fill two questionnaires about their symptoms. Participants will then be provided with a 10 day bowel and symptom diary and a 10 day supply of blinded the intestinal adsorbent . Participants will be provided with instructions on how to take the the study product and training on completing their daily diary. They will be required to take the study product for 10 consecutive days according to manufacturers instructions.

Participants will return for the second and final visit on the final day of consuming the study product. The day before visit 2 the patient will be required to follow a low residue diet as part of preparation for the hydrogen methane breath. On the day of the second visit participants will complete a hydrogen methane breath test as per the functional gut clinics test protocol, the patient will also be asked to fill two questionnaires about their symptoms. Once these study procedures are complete the participants will have finished their participation in the study.

Conditions

Gastroesophageal Reflux; Small Intestinal Bacterial Overgrowth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Intestial adsorbent arm

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

Group Type: EXPERIMENTAL

Intestinal adsorbent

Intervention Type: 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.

Interventions

Intestinal adsorbent

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

1. Participant reports using any prohibited medication, medical device or supplementation

2. Participant has taken antibiotics or undergone colonoscopy/sigmoidoscopy in the 4 weeks prior to enrolment.

3. Participant has a diagnosis of any organic gastrointestinal disease, including inflammatory bowel disease, coeliac disease and diverticulitis.

4. Participant has known mechanical obstruction of the GI tract

5. Participant has diabetes

6. Participant has any hepatic disease

7. Participant has any disease of the CNS

8. Participant is involved in this study as an Investigator, sub-Investigator, study coordinator, other study staff, or Sponsor member.

9. Participant has had previous abdominal or colorectal surgery except appendectomy, cholecystectomy, or hysterectomy.

10. Participant has previously taken Silicolgel in the past month

11. Participant has a known hypersensitivity to any of the ingredients of Silicolgel

12. Participant suffers regularly from constipation

13. Participant is involved in any other research projects either currently or during the previous month

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr Anthony Hobson

OTHER

Sponsor Role: lead

Responsible Party

Dr Anthony Hobson

Clinical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony Hobson, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Director

Locations

The Functional Gut Clinic

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

FGC-19-001

Identifier Type: -

Identifier Source: org_study_id