Ignite Creation Date:
2024-05-06 @ 3:00 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04492839
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2020-07-09
Brief Title:
Intestinal Adsorbent and Breath Gas Levels
Sponsor:
Dr Anthony Hobson
Organization:
The Functional Gut Clinic
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None