Efficacy and Safety of Multiple Faecal Microbiota Transfers in Acute Pouchitis

Phase 2

Withdrawn

Conditions: inflammation of the pouch reservoir
Pouchitis
10017969

Registration Number: NL-OMON49333

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

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.)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of patients in clinical and endoscopic<br /><br>remission at week 8. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The main secondary endpoints are antibiotic-free clinical and endoscopic<br /><br>remission at week 52, and changes in microbiota signature, functional profiling<br /><br>as well as metabolic output from baseline to week 8 and week 52.<br /><br>To study the speed of clinical remission induction of pouchitis after FMT.</p><br>