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

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.

Study Overview

• Status: Completed
• Conditions: Fecal Microbiota Transplantation
• Intervention / Treatment: Other: Delivery of contrast fluid by lower GI endoscopy; Other: Delivery of contrast fluid by enema with and without positioning

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Harstad, Troms, Norway, 9406
      • University Hospital of North Norway, Harstad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Contrast fluid by lower GI endoscopy and enema with and without positioning; 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; 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: The participant lies on his/her left side in neutral position when the enema is delivered; X-ray of the colon is obtained with the participant lying on his/her back.; The participant is positioned back to his/her left sided position and tilted in a Trendelenburg position. The position is held for two minutes; The participant is turned to an abdominal position while the bed remains tilted in Trendelenburg position.; Participant turne to the right side. When positioned the bed is tilted the opposite way (anti-Trendelenburg.) The position is held for two minutes.; A second colon X-ray is obtained after the participants has rested for ten minutes in a supine neutral position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Investigators: Principal Investigator: Peter H Johnsen, MD PhD, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): May 18, 2022
• Study Completion (Actual): May 18, 2022

Study Registration Dates

• First Submitted: November 3, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 267433

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Study protocol with statistical analysis plan will be uploaded to the ClinicalTrials.gov web site.
• IPD Sharing Time Frame: Within 2021
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No