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

  • STATUS
    Recruiting
  • days left to enroll
    37
  • participants needed
    8
  • sponsor
    University Hospital of North Norway
Updated on 22 November 2021

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.

Details
Condition Fecal Microbiota Transplantation
Treatment Delivery of contrast fluid by lower GI endoscopy, Delivery of contrast fluid by enema with and without positioning
Clinical Study IdentifierNCT05121285
SponsorUniversity Hospital of North Norway
Last Modified on22 November 2021

Eligibility

Yes No Not Sure

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
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