NCT05121285

Distribution of FMT After Delivery by · Lower GI Endoscopy vs Enema With and Without Positioning of the Patient

Distribution of FMT After Delivery by · Lower GI Endoscopy vs· Enema With and Without Positioning of the Patient

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University Hospital of North Norway · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Fecal Microbiota Transplantation

Interventions

Type	Name	Description
OTHER	Delivery of contrast fluid by lower GI endoscopy	Each participant will receive one delivery of 440 ml contrast fluid by lower GI endoscopy to the cecum of the colon. The participants perform a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) 24 hours before the delivery of contrast fluid. An colon X-ray is obtained within 10 minutes after the contrast fluid is delivered. The participants is in a supine position fram delivery and until the colon x-ray is obtained.
OTHER	Delivery of contrast fluid by enema with and without positioning	Each participant will receive one delivery of 440 ml contrast fluid by enema. The participants perform a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) 24 hours before the delivery of contrast fluid. The enema procedure includes: 1. The participant lies on his/her left side in neutral position when the enema is delivered 2. X-ray of the colon is obtained with the participant lying on his/her back. 3. The participant is positioned back to his/her left sided position and tilted in a Trendelenburg position. The position is held for two minutes 4. The participant is turned to an abdominal position while the bed remains tilted in Trendelenburg position. 5. Participant turne to the right side. When positioned the bed is tilted the opposite way (anti-Trendelenburg.) The position is held for two minutes. 6. A second colon X-ray is obtained after the participants has rested for ten minutes in a supine neutral position

Timeline

• Start date: 2021-10-25
• Primary completion: 2022-05-18
• Completion: 2022-05-18
• First posted: 2021-11-16
• Last updated: 2022-06-06

Locations

1 site across 1 country: Norway