Transplantation of faeces in ulcerative colitis; restoring nature*s homeostasis

Phase 2

Recruiting

Conditions: inflammatory bowel disease
ulcerative colitis
10017969
10003816

Registration Number: NL-OMON36482

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

*Age *18
*Ability to give informed consent
*Established left sided ulcerative colitis according to the Lennard-Jones criteria
*SCCAI (Simple Clinical Colitis Activity Index) of 4 - 11
*Endoscopic Mayo score of >1
*Stable dose of thiopurines, 5-ASA, or corticosteroids in preceding 8 weeks
*Women need to use reliable contraceptives during participation in the study

Exclusion Criteria

* condition leading to profound immunosuppression
o For example: HIV, infectious diseases leading to imunosuppression, bone marrow malignancies
o Use of systemic chemotherapy
* Anti-TNF treatment in preceding 2 months
* Ciclosporine treatment in preceding 4 weeks
* Prednisolone dose * 10 mg
* Life expectancy < 12 months
* Use of antibiotics in preceding 6 weeks
* Use of probiotic treatment in preceding 6 weeks
* Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
* History of surgery:
o hemicolectomie (defined as: surgery resulting in a resection of > * of the colon)
o presence of a pouch due to surgery
o Presence of stoma
* Known intra-abdominal fistula
* Pregnancy or women who give brestfeeding
* Vasopressive medication, icu stay
* Signs of ileus, diminished passage
* Allergy to macrogol or substituents, eg peanuts, shellfish

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* Complete clinical remission (SCCAI <2).<br /><br>* Reduction of Mayo endoscopic inflammation score (decrement >1) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Adverse events (AE) at t=3, t=6 and t=12 weeks<br /><br>* SCCAI score reduction at t=6 weeks (pairwise SSCAI reduction of > 1.5 points<br /><br>will be regarded as a relevant reduction (10))<br /><br>* Frequency of bowel movements (starting to report at t= -2 weeks)<br /><br>* Reduction of Mayo endoscopic score at t=6 wk<br /><br>* Time to recurrence (recurrence is defined as a SCCAI of 4 and Mayo score 1<br /><br>(10))<br /><br>* Intra individual changes in presence of microbial DNA in faecal samples at<br /><br>t=0, t=6, and t=12 weeks after faecal transplantation.<br /><br>* Intra individual changes in presence of microbial DNA in mucosal biopsies at<br /><br>t=0, t=6, and t=12 weeks after faecal transplantation. </p><br>