Faecal Microbiota Transplantation From Normal Pouch Function Donor in the Treatment of Chronic Pouchitis

NCT04820413 | Completed

• 1 other identifier: MicroPouch-NP
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with chronic pouchitis is disabled by bloody diarrhoea and abdominal pain often followed by fever. Pouchitis is an inflammation in a pouch, a reservoir formed by the small intestine in the management of the chronic inflammatory bowel disease, ulcerative colitis. The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Studies show that patients with pouchitis have an altered composition of the gut microbiota compared to healthy individuals and patients with a pouch without inflammation. As shown by several studies, faecal microbiota transplantation (FMT) with administration of faeces from healthy donors can alter the microbiota. Treatment with faecal microbiota transplantation to chronic pouchitis has been investigated in several clinical trials with mixed results. It is however still uncertain if faecal microbiota transplantation using stool from healthy individuals with a colon is optimal, or if stool from patient with a normally functioning pouch should be used. The study primary aims to investigate if transplantation of faeces from patient with a normal pouch function can induce clinical remission in patients with chronic pouchitis.

Conditions

Pouchitis; Inflammatory Bowel Diseases; Ulcerative Colitis

Keywords

FMT; Microbiota

Outcome Measures

Primary Outcomes (1)

• Number of patients achieving clinical remission assessed by PDAI

  Clinical remission is defined as PDAI\<7

  4 weeks

Secondary Outcomes (2)

• Number of patients achieving clinical response assessed by PDAI

  4 weeks

• Engraftment of the donor microbiota in the patients

  4 weeks

Study Arms (1)

FMT

EXPERIMENTAL

Other: Faecal microbiota transplantation

Interventions

Faecal microbiota transplantation OTHER

FMT by daily enema with donor faeces

FMT

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years of age with a J-pouch
• PDAI ≥ 7
• Established diagnosis of chronic pouchitis (≥3 times of pouchitis within the last year, symptoms more than 4 weeks despite antibiotic treatment)
• Antibiotic treatment for pouchitis (ciprofloxacin and/or metronidazole) within the 3 months

You may not qualify if:

• Immunosuppression
• Pregnancy or breastfeeding
• Any severe or newly diagnosed concomitant cardiovascular, hepatic, intestinal, renal, endocrine, pulmonary, dental disease with inflammation or psychiatric disorder, which, in the opinion of the investigator, might have an influence on the patient's compliance or the interpretation of the results
• Probiotic intake within the last 2 weeks prior to study intervention
• Participation in another clinical trial within the previous 30 days before baseline
• Serious food allergies with earlier anaphylactic reactions

Sponsors & Collaborators

• Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery: lead

Study Sites (1)

Department of Gastrointestinal Surgery, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

MeSH Terms

Conditions

Pouchitis; Inflammatory Bowel Diseases; Colitis, Ulcerative

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Ole Thorlacius-Ussing, Professor

  Aalborg University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of surgery, Consultant surgeon, DMSc

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 29, 2021
• Study Start: March 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)