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

NCT05121285 | Completed

• 1 other identifier: 267433
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Proportion of transverse colon projection after CF delivery by the lower GI endoscopy versus enema with positioning versus enema without positioning of the participants.

  10-20 minutes after contrast fluid delivery

Study Arms (1)

Contrast fluid by lower GI endoscopy and enema with and without positioning

EXPERIMENTAL

There is a washout period of at least four weeks between the two interventions (delivery by lower GI endoscopy and enema)

Other: Delivery of contrast fluid by lower GI endoscopy; Other: Delivery of contrast fluid by enema with and without positioning

Interventions

Delivery of contrast fluid by lower GI endoscopy OTHER

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.

Contrast fluid by lower GI endoscopy and enema with and without positioning

Delivery of contrast fluid by enema with and without positioning OTHER

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

Contrast fluid by lower GI endoscopy and enema with and without positioning

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for colonoscopy at the medical department at UNN Harstad
• Able to complete the positioning procedure during the enema

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital of North Norway: lead

Study Sites (1)

University Hospital of North Norway, Harstad

Harstad, Troms, 9406, Norway

Location

Related Publications (1)

• Skjevling LK, Hanssen HM, Valle PC, Goll R, Juul FE, Arlov O, Johnsen PH. Colonic distribution of FMT by different enema procedures compared to colonoscopy - proof of concept study using contrast fluid. BMC Gastroenterol. 2023 Oct 23;23(1):363. doi: 10.1186/s12876-023-02979-x.

  PMID: 37872499 DERIVED

MeSH Terms

Interventions

Patient Positioning

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Peter H Johnsen, MD PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: October 25, 2021
• Primary Completion: May 18, 2022
• Study Completion: May 18, 2022
• Last Updated: June 6, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Within 2021

Locations

NO (1)