Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04100291 |
| Other study ID # |
MicroPouch |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2019 |
| Est. completion date |
March 1, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Aalborg University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Hypothesis:
Gut dysbiosis plays a significant causal role in chronic pouchitis. Modulating the gut
microbiota using FMT has a clinical effect by inducing clinical remission in patients with
chronic pouchitis.
Objective of the study:
The aim of the MicroPouch-trial is to investigate if transplantation (FMT) of faeces from
healthy donors to patients with chronic pouchitis is clinical significant to placebo for the
treatment of pouchitis.
Study design:
The project is designed as a multi-center, double-blinded, randomized, placebo-controlled
treatment study.
Methods:
Faecal microbiota transplantation is performed with faeces from healthy donors. Potential
donors are recruited from the Danish Blood Bank. They are screened for a various of
infectious diseases by serum analysis (haematology, inflammation, liver and kidney function,
HIV, Hepatitis, Cytomegalovirus, Epstein Barr virus and HbA1c) and faeces analysis
(calprotectin, Clostridium difficile (PCR), enteric pathogenic bacteria and
antibiotic-resistant bacteria, parasites, cysts, and viruses). Furthermore, the potential
donors will complete an extensive questionnaire regarding general health, risk factors and
medical history, before they can be included as faecal donors in the project. The screening
procedure is based on recommendation from the European FMT Working Group.
The transplantation is performed by enemas, which contain either faeces from the faecal
donors or placebo.
Initial before the treatment with either donor faeces or placebo, the patient will be invited
for serum analysis (CRP, leukocytes) and faecal analysis (calprotectin, Clostridium
difficile, enteric pathogenic bacteria), followed by a pouchoscopy with collection of
biopsies. Materials from serum- and faecal analysis and biopsies will be stored for later
analysis purpose. The patient will further complete questionnaires concerning symptoms and
quality of life. The stage of disease will be evaluated based on the acknowledged
questionnaire for pouchitis called Pouchitis Disease Activity Index (PDAI) score.
The treatment begins after all the initial examinations, and the patient will be treated
during one month. The treatment consists of daily enema infusion, which either contain faeces
from the faecal donors or placebo. During the treatment, the patient will daily record
symptoms related to pouchitis (diarrhea, abdominal pain, bleeding per rectum, fever, general
discomfort) and possible adverse effects to the treatment.
At the end of treatment, the patient will meet to a follow-up examination including serum
analysis (CRP, leukocytes) and faecal analysis (calprotectin), pouchoscopy incl. biopsies,
and the questionnaires applied before the treatment. Materials from serum- and faecal
analysis and biopsies will be stored for later analysis.
The patient will be followed up with serum- and faecal analysis and pouchoscopy after
additional 6 and 12 months to evaluate the long term effect of the transplantation. The
consumption of antibiotics during the first year will be recorded. In case of lacking effect
of faecal microbiota transplantation, the patient is offered standard antibiotic treatment
for pouchitis, and will leave the study.
Faecal samples and biopsies collected in the study will be analyzed for the composition of
the microbiota.
