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Fecal Transplantation for Chronic Pouchitis - A Pilot Study

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ClinicalTrials.gov Identifier: NCT03538366
Recruitment Status : Completed
First Posted : May 28, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital

Tracking Information
First Submitted Date  ICMJE May 11, 2018
First Posted Date  ICMJE May 28, 2018
Last Update Posted Date May 6, 2019
Actual Study Start Date  ICMJE May 15, 2018
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
Cure 30 days following FMT treatment [ Time Frame: 30 days ]
PDAI < 7
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03538366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2018)
  • Clinical response 30 days after FMT treatment [ Time Frame: 30 days ]
    Decrease from baseline PDAI > 2 points
  • Histological remission following PDAI [ Time Frame: 30 days ]
    Remission of microscopic inflammation
  • Improvement of pouch function [ Time Frame: 30 days ]
    Improvement of the self-reported questionnaire
  • Improvement of quality of life [ Time Frame: 30 days ]
    Improvement of the self-reported questionnaire
  • Improvement of sexuality [ Time Frame: 30 days ]
    Improvement of the self-reported questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fecal Transplantation for Chronic Pouchitis - A Pilot Study
Official Title  ICMJE Fecal Transplantation for the Treatment of Chronic Pouchitis - A Pilot Study
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Ulcerative Colitis
  • Pouchitis
Intervention  ICMJE Other: Donor FMT
Fecal transplant from unrelated, healthy donors using enemas
Study Arms  ICMJE Experimental: Donor FMT
Fecal transplant from unrelated, healthy volunteers
Intervention: Other: Donor FMT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 24, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date May 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03538366
Other Study ID Numbers  ICMJE FMT and Pouchitis
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital
Study Sponsor  ICMJE Aalborg University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Ole Thorlacius-Ussing, Professor Aalborg University Hospital, Aalborg University
PRS Account Aalborg University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP