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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

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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Pouchitis Other: Donor FMT Not Applicable

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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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Transplantation for the Treatment of Chronic Pouchitis - A Pilot Study
Actual Study Start Date : May 15, 2018
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




Primary Outcome Measures :
  1. Cure 30 days following FMT treatment [ Time Frame: 30 days ]
    PDAI < 7


Secondary Outcome Measures :
  1. Clinical response 30 days after FMT treatment [ Time Frame: 30 days ]
    Decrease from baseline PDAI > 2 points

  2. Histological remission following PDAI [ Time Frame: 30 days ]
    Remission of microscopic inflammation

  3. Improvement of pouch function [ Time Frame: 30 days ]
    Improvement of the self-reported questionnaire

  4. Improvement of quality of life [ Time Frame: 30 days ]
    Improvement of the self-reported questionnaire

  5. Improvement of sexuality [ Time Frame: 30 days ]
    Improvement of the self-reported questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538366


Locations
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Denmark
Research Unit, Department of Gastrointestinal Surgery
Aalborg, Denmark, 9000
Sponsors and Collaborators
Aalborg University Hospital
Investigators
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Study Director: Ole Thorlacius-Ussing, Professor Aalborg University Hospital, Aalborg University

Publications:

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Responsible Party: Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, MD, DMSc, Professor of Surgery, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03538366     History of Changes
Other Study ID Numbers: FMT and Pouchitis
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital:
Ulcerative Colitis
Inflammatory bowel disease
Pouchitis
Fecal microbiota transplant
Fecal microbiota treatment
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Pouchitis
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Ileitis
Enteritis
Ileal Diseases