To study the effectiveness and safety of administration of FMT on acute pouchitis.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the proportion of patients in clinical and endoscopic
remission at week 8.
Secondary outcome
The main secondary endpoints are antibiotic-free clinical and endoscopic
remission at week 52, and changes in microbiota signature, functional profiling
as well as metabolic output from baseline to week 8 and week 52.
To study the speed of clinical remission induction of pouchitis after FMT.
Background summary
Pouchitis is defined as inflammation of the ileal pouch reservoir and is the
most frequent complication in patients with an ileal pouch anal anastomosis
(IPAA) after rectoproctocolectomy (RPC) for ulcerative colitis (UC). The
cumulative incidence of pouchitis has been reported to be as high as 59% in UC
patients(1, 2). However, the pathophysiology of pouchitis is not completely
understood. Increasing evidence suggests the microbiome plays a key role in the
pathogenesis of pouchitis. Clinical effectiveness of broad-spectrum antibiotics
such as metronidazole and ciprofloxacin implies bacteria play an important role
in the development of pouchitis(3, 4). To support this dysbiosis hypothesis,
pouchitis usually only occurs after ileostomy closure, suggesting exposure to
the faecal stream, and subsequently the microbiome, plays a key role in the
pathogenesis of pouchitis.
Taking this information into account, treating pouchitis by modulating the
microbiome might be an attractive solution in pouch patients. A potential
approach to accomplish this is by faecal microbiota transfer (FMT). FMT has
proved to be successful in treating Clostridium difficile infections and is
gaining popularity in inflammatory bowel diseases (IBD) as well.
Study objective
To study the effectiveness and safety of administration of FMT on acute
pouchitis.
Study design
Single arm, proof of concept clinical trial in which 20 patients will be
included.
Intervention
Patients will receive a multiple faecal microbiota transfers from healthy,
carefully selected donors.
Study burden and risks
Total follow-up time will be 52 weeks, during which 7 study visits are planned.
FMT will be administered by nasojejunal tube at week 0 and week 3 as well as by
retention enema at week 0, 1, 2, and 3. Nasojejunal tube placement will be
performed by a Cortrak pro-cedure. This is a routine procedure in our centres
and is associated with a very small risk of complications. The same applies to
pouchoscopies, which patients will have to undergo three times with biopsies.
From our earlier trials we know that nasojejunal FMT administration is well
tolerated. In the TURN trial conducted previously in the Amsterdam UMC, one in
100 administrations resulted in vomiting, which amounts to a total of two
occurrences. Most patients complained of transient borborygmi and in two
patients transient fever was seen. No serious adverse events attributable to
FMT have been encountered with nasojejunal FMT administration in over 500 study
subjects in the Amsterdam UMC.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
• IPAA for ulcerative colitis
• Episode of acute pouchitis, defined as a PDAI >= 7, and endoscopic subscore of
> 2
• History of at least one episode of pouchitis, which necessitated antibiotic
treatment.
Exclusion criteria
- Pouchitis due to surgery related conditions (i.e. abscess, fistula. sinus of
the pouch), identified by endoscopic assessment of the pouch
- Crohn's Disease
- Patients with signs of severe systemic inflammation (at least two of the
following symptoms: temperature > 38.5 *C, tachycardia > 100 bpm (after
rehydration), systolic blood pressure < 100 mmHg).
- Patients with severe pouchitis on endoscopy who require immediate
intervention, based on the discretion of the endoscopist.
- Mechanical complications of the pouch (i.e. pouch stricture, pouch fistula)
- Diverting ileostomy
- Use of systemic antibiotic or probiotic therapy in the preceding 4 weeks.
- Use of concurrent anti-inflammatory drugs (i.e. thiopurines, anti-TNF,
corticosteroids, etc.)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71381.018.20 |
| Other | NL7770 |