Fecal Transplantation for Chronic Pouchitis - A Pilot Study
|ClinicalTrials.gov Identifier: NCT03538366|
Recruitment Status : Completed
First Posted : May 28, 2018
Last Update Posted : May 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis Pouchitis||Other: Donor FMT||Not Applicable|
Hide Detailed Description
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.
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:
- Questionaire regarding possible contagious infectious diseases, followed by interview with principal investigator.
- Blood test for: inflammatory parameters: CRP, leucocyte count, HIV 1+2 antigen, Hepatitis A, B and C, CMV, EBV and HbA1c
- Pathogenic bacteria (Salmonella, Campylobacter, Yersinia, Shigella), Vibrio, toxin-producing E. coli.
- Parasites, giardia spp. and cryptosporidium spp.
- Adenovirus, enterovirus, parechovirus
- Clostridium difficile
- 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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Donor FMT
Fecal transplant from unrelated, healthy volunteers
Other: Donor FMT
Fecal transplant from unrelated, healthy donors using enemas
- Cure 30 days following FMT treatment [ Time Frame: 30 days ]PDAI < 7
- 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
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
|Research Unit, Department of Gastrointestinal Surgery|
|Aalborg, Denmark, 9000|
|Study Director:||Ole Thorlacius-Ussing, Professor||Aalborg University Hospital, Aalborg University|