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

University Hospital of North Norway

Status: Completed

Conditions: Fecal Microbiota Transplantation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05121285

267433

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

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

Experimental group

Description:

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

Treatment:

Other: Delivery of contrast fluid by lower GI endoscopy

Other: Delivery of contrast fluid by enema with and without positioning