Fecal Microbiota Transplantation Clinical Trial
Official title:
Distribution of FMT After Delivery by · Lower GI Endoscopy vs· Enema With and Without Positioning of the Patient
NCT number | NCT05121285 |
Other study ID # | 267433 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 25, 2021 |
Est. completion date | May 18, 2022 |
Verified date | October 2021 |
Source | University Hospital of North Norway |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
While delivery of an FMT-treatment to the cecum is visualized in a lower GI-endoscopy, it is uncertain whether delivery by enema distributes the FMT to the proximal segments of the colon. Positioning of the patient during the enema procedure may improve distribution to the proximal colon. Differences in distribution may explain the wide effect range and inferiority when enema is compared to delivery by lower GI endoscopy. Thus, in this study we will compare the distribution of FMT from delivery by lower GI endoscopy versus enema with and without positioning of the patient. We will use contrast fluid as a surrogate liquid for FMT to project the distribution on colon X-ray pictures. To our knowledge this is not done in any previous study.
Status | Completed |
Enrollment | 8 |
Est. completion date | May 18, 2022 |
Est. primary completion date | May 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Scheduled for colonoscopy at the medical department at UNN Harstad - Able to complete the positioning procedure during the enema Exclusion Criteria: - Confirmed malignancy - Inflammatory bowel disease - Referral highly suspicious of cancer, inflammatory bowel disease or obstructive GI disease - Contraindications for rectal catheter insertion (including known damage to pelvic floor, sphincter or the pudendal nerve) - Use of anticoagulants. Use of acetylsalicylic acid is allowed - Symptomatic cardiovascular or lung disease - Kidney failure - Known allergic reaction to any component in Liquid Polibar Plus - Pregnant, lactating or planning pregnancy - Asthma |
Country | Name | City | State |
---|---|---|---|
Norway | University Hospital of North Norway, Harstad | Harstad | Troms |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of cecum projection after CF delivery by lower GI endoscopy versus enema with positioning versus enema without positioning of the participants. | Two radiologist determine the projection each colon X-ray picture by identifying segments where the gut mucosa is coated with contrast fluid and/or segments with contrast fluid in the lumen. The radiologist is blinded to which delivery method is used. | 10 minutes after contrast fluid delivery | |
Secondary | Proportion of transverse colon projection after CF delivery by the lower GI endoscopy versus enema with positioning versus enema without positioning of the participants. | Two radiologist determine the projection each colon X-ray picture by identifying segments where the gut mucosa is coated with contrast fluid and/or segments with contrast fluid in the lumen. The radiologist is blinded to which delivery method is used. | 10-20 minutes after contrast fluid delivery |
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