Gastroesophageal RefluxNCT04492839
Intestinal Adsorbent and Breath Gas Levels
A study testing Intestinal adsorbent in people with Gastroesophageal Reflux and Small Intestinal Bacterial Overgrowth, run by Dr Anthony Hobson at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Small Intestinal Bacterial Overgrowth
- What is being tested?
- Intestinal adsorbent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Aug 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of an Intestinal Adsorbent on Hydrogen and Methane Breath Testing, in Patients With Abdominal and Reflux Symptoms, on Long Term Proton Pump Inhibitor Therapy
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.
Read the 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.
- Being tested
- Intestinal adsorbent
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal adsorbentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intestial adsorbent arm | Experimental | This is a single arm study, all participants will receive the class IIa intestinal adsorbent medical device Receives: Device: Intestinal adsorbent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
The IBS-SSS is a validated questionnaire that will be used to determine severity of abdominal and bowel symptoms. The questionnaire is comprised of 7 questions, 5 of which are scored from 0 to 10. The total of these 5 questions will be calculated and multiplied by 10 to determine symptom severity. Mean difference in scores from baseline IBS-SSS and end of study IBS-SSS will be determined using a paired t-test, to determine significance (p<0.05).
Measured: 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.
The Reflux Questionnaire is a validated questionnaire that will be used to determine severity of upper GI symptoms. The questionnaire is made up of 16 questions, each scored 0 to 5. The total of these 16 questions will be calculated to determine symptom severity. Mean difference in scores from baseline reflux questionnaire and end of study reflux questionnaire will be determined using a paired t-test, to determine significance (p<0.05).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start13 Aug 2019
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Anthony Hobson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Anthony Hobson, The Functional Gut Clinic
- Investigators
- Anthony Hobson, PhD, Principal investigator, Clinical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492839
- Sponsor's protocol ID
- FGC-19-001
- Status last verified
- Apr 2022
- First submitted
- 9 Jul 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Intestinal Adsorbent on Hydrogen and Methane Breath Testing, in Patients With Abdominal and Reflux Symptoms, on Long Term Proton Pump Inhibitor Therapy
- ClinicalTrials.gov ID
- NCT04492839
- Acronym / sponsor ID
- FGC-19-001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr Anthony HobsonUniversity, hospital or other
- Study start
- 13 Aug 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intestial adsorbent arm | Experimental | Device: Intestinal adsorbentThis is a single arm study, all participants will receive the class IIa intestinal adsorbent medical device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinal adsorbentParticipants 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. | Device | Intestial adsorbent arm |
Primary outcome
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.
Time frame: 18 months
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.
2 secondary outcomes
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.
Time frame: 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.
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Hobson, PhD principal investigator
Clinical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinal adsorbent in people with Gastroesophageal Reflux and Small Intestinal Bacterial Overgrowth, run by Dr Anthony Hobson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.