Faecal Microbiota Transplantation in the Treatment of Chronic Pouchitis

NCT04100291 | Terminated

• 1 other identifier: MicroPouch
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with the chronic bowel disease 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. Chronic pouchitis is a rare disease with a prevalence in Denmark of \<1.8 per 10,000 people, mostly younger people (\<50 years). The standard treatment for pouchitis is intensive broad-spectrum antibiotics for a longer period. However, the treatment often fails after repeated treatments. Recent studies show that patients with pouchitis have an altered composition of the gut flora, called microbiota, compared to healthy individuals. 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 is today known to be the ultimate treatment for antibiotic resistant recurrent bowel infection with the bacteria Clostridium difficile. It is however still uncertain if faecal microbiota transplantation can be used to the treatment of chronic pouchitis. The study primary aims to investigate if transplantation of faeces from healthy donors administrated as enemas to patients with chronic pouchitis is superior to placebo for the treatment of pouchitis. The project is designed as a multi-center, double-blinded, randomized, placebo-controlled treatment study. A positive result from the project will result in an improved treatment to pouchitis patients. Moreover, repeated long-lasting broad-spectrum treatments with antibiotic, which carry a high risk of antibiotic resistance in the society, will be avoided.

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 (6)

• Number of patients achieving clinical response assessed by PDAI

  4 weeks

• Number of patients experience improvement in quality of life assessed by the patient-reported questionnaire SIBDQ

  4 weeks

• Number of patients relapsing

  12 months

• Number of patients with treatment-related adverse events in the FMT group compared to the placebo group

  12 months

• Increase of the faecal microbiota biodiversity assessed by alpha-diversity

  12 months

Study Arms (2)

FMT

ACTIVE COMPARATOR

Faecal microbiota transplantation

Other: Faecal microbiota transplantation

Placebo

PLACEBO COMPARATOR

Placebo mixture

Other: Placebo

Interventions

Faecal microbiota transplantation OTHER

FMT by daily enema with donor faeces

FMT

Placebo OTHER

Placebo by daily enema with placebo mixture

Placebo

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 last year
• Not pregnant or breastfeeding

You may not qualify if:

• Immunosuppression
• Pregnancy
• 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 (2)

Department of Gastrointestinal Surgery, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Department of Medical Gastroenterology, Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (2)

• Cammarota G, Ianiro G, Tilg H, Rajilic-Stojanovic M, Kump P, Satokari R, Sokol H, Arkkila P, Pintus C, Hart A, Segal J, Aloi M, Masucci L, Molinaro A, Scaldaferri F, Gasbarrini G, Lopez-Sanroman A, Link A, de Groot P, de Vos WM, Hogenauer C, Malfertheiner P, Mattila E, Milosavljevic T, Nieuwdorp M, Sanguinetti M, Simren M, Gasbarrini A; European FMT Working Group. European consensus conference on faecal microbiota transplantation in clinical practice. Gut. 2017 Apr;66(4):569-580. doi: 10.1136/gutjnl-2016-313017. Epub 2017 Jan 13.

  PMID: 28087657 BACKGROUND

• Kousgaard SJ, Cold F, Halkjaer SI, Petersen AM, Kjeldsen J, Hansen JM, Dall SM, Albertsen M, Nielsen HL, Kirk KF, Duch K, Sonderkaer M, Thorlacius-Ussing O. The Effect of Non-pooled Multidonor Faecal Microbiota Transplantation for Inducing Clinical Remission in Patients with Chronic Pouchitis: Results from a Multicentre, Randomised, Double-blinded, Placebo-controlled Trial [MicroPouch]. J Crohns Colitis. 2024 Nov 4;18(11):1753-1766. doi: 10.1093/ecco-jcc/jjae066.

  PMID: 38708959 DERIVED

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 24, 2019
• Study Start: July 1, 2019
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)