Fecal Microbiota Transplantation for Chronic Pouchitis

December 17, 2019 updated by: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital

Fecal Microbiota Transplantation for the Treatment of Chronic Pouchitis

Patients with chronic pouchitis are treated with fecal transplant from several unrelated, healthy donors. The treatment consists of enemas of 100 mL fecal suspension, applied for 14 consecutive days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background:

The surgical treatment of choice for the treatment of medically refractory ulcerative colitis (UC) is restorative ileal pouch-anal anastomosis (IPAA), in which the patient retains fecal continence following colonectomy, by subsequent anastomosis of the terminal ileum and the rectum.

Up to 25% of patients with UC will undergo IPAA surgery. The most common complication following the procedure is inflammation of the pouch (pouchitis), which is seen in up to 50% of patients within the first five years of surgery. Of these patients, 10-20% will develop a chronic inflammatory condition. The clinical symptoms of pouchitis include diarrhea, rectal bleeding, stomach cramps, general malaise and reduced quality of life. Endoscopic findings include mucosal edema, granulations, and ulcerations with mucosal frailty. In most cases, a causative microorganism is not identified, although infection with Clostridium difficile or Cytomegalovirus (CMV) have been reported.

The most common treatment of pouchitis is empiric antibiotics, usually quinolones and metronidazole, or a combination of both. Following complications, removal of the pouch can become a last resort, and chronic pouchitis is the leading indication for 10% of these operations.

The composition of microbes in the gut is known to be a key factor in the homeostasis of the intestine, and plays a central role in the development of CIBD. Different single microorganisms have previously been suggested as playing an important role in this development, including: Mycobacterium avium, Escherichia coli and Clostridium difficile, that all have invasive capabilities. Several studies have investigated the connection between the composition of microbes in the gut and development of pouchitis finding an increasing evidence for a link between dysbiosis and pouchitis.

Method:

Patients with chronic pouchitis are treated with fecal transplants from unrelated, healthy donors. The fecal transplant is from several healthy donors. The treatments are applied as enemas of 100 ml suspension for 14 consecutive days.

Prior to treatment, pouchitis activity is graded using the pouchitis disease activity index (PDAI) based on symptoms, endoscopic and histological criteria. Patients will also complete self-reported questionnaires regarding pouch function, quality of life and sexuality.

Patients are evaluated using the PDAI score 30 days following treatment together with the self-reported questionnaires. Longterm follow up is evaluated up to 6 months following FMT.

Screening of FMT donors:

  1. Questionaire regarding possible contagious infectious diseases, followed by interview with principal investigator.
  2. Blood test for: inflammatory parameters: CRP, leucocyte count, HIV 1+2 antigen, Hepatitis A, B and C, CMV, EBV and HbA1c

  3. Fecal samples:

    1. Calprotectin
    2. Pathogenic bacteria (Salmonella, Campylobacter, Yersinia, Shigella), Vibrio, toxin-producing E. coli.
    3. Parasites, giardia spp. and cryptosporidium spp.
    4. Adenovirus, enterovirus, parechovirus
    5. Clostridium difficile
    6. Vancomycin-resistent Enterococcus faecalis and Enterococcus faecium, carbapenemase-producing enterobacteria and ESBL-producing E.coli.

FMT donor exclusion criteria are:

  • Age <20 or >65
  • BMI <18.5 or > 28.0 kg/m2
  • Known chronic inflammatory bowel disease, celiac disease, rheumatoid arthritis or other autoimmune disease, sclerosis, psoriasis, previous extensive bowel surgery
  • In the previous 6 months:
  • Diarrhea > 3 days in one week or bloody stools
  • Treatment with antibiotics
  • Risk of sexually transmitted disease, tattoos, piercings, travel to areas with high endemic transmission of infectious diseases or resistants microbes.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Research Unit, Department of Gastrointestinal Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • minimum 18 years old, pouch > 1 year
  • at least three pouchitis events in the past year
  • antibiotic treatment for pouchitis at least one time in the past year

Exclusion Criteria:

  • immunosuppression, pregnancy, detection of specific pathogens in stool

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Donor FMT
Fecal transplant from unrelated, healthy volunteers
Other: Donor FMT
Fecal transplant from unrelated, healthy donors using enemas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure 30 days following FMT treatment
Time Frame: 30 days
PDAI < 7
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the microbiota
Time Frame: 30 days
Changes in diversity of gut microbiota after FMT assessed by Shannon index
30 days
Clinical response 30 days after FMT treatment
Time Frame: 30 days
Decrease from baseline PDAI > 2 points
30 days
Histological remission following PDAI
Time Frame: 30 days
Remission of microscopic inflammation
30 days
Improvement of pouch function
Time Frame: 30 days
Improvement of the self-reported questionnaire
30 days
Improvement of quality of life
Time Frame: 30 days
Improvement of the self-reported questionnaire
30 days
Improvement of sexuality
Time Frame: 30 days
Improvement of the self-reported questionnaire
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aalborg University Hospital

Investigators

  • Study Director: Ole Thorlacius-Ussing, Professor, Aalborg University Hospital, Aalborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2018

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

May 11, 2018

First Submitted That Met QC Criteria

May 24, 2018

First Posted (Actual)

May 29, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2019

Last Update Submitted That Met QC Criteria

December 17, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT and Pouchitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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