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Completed

NCT Number: NCT05121285

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.

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Key information

Conditions

Fecal Microbiota Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of North Norway, Harstad

Harstad, Troms, 9406, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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:

  • 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

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.

    Time frame: 10 minutes after contrast fluid delivery

    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.

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.

    Time frame: 10-20 minutes after contrast fluid delivery

    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.

Sponsors and collaborators

Lead sponsor

University Hospital of North Norway

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 16, 2021
Registry last updated
Jun 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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