Transfer of feces in ulcerative colitis 2; improving efficacy

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 76

Inclusion Criteria

• Age >=18 and <70
• Ability to give informed consent
• Established ulcerative colitis with known involvement of the left colon
according to the Lennard-Jones criteria
• Full Mayo score 5-9
• Endoscopic Mayo score of >= 2 in either the rectum or sigmoid upon screening
sigmoidoscopy
• Stable dose of thiopurines, 5-ASA, in preceding 8 weeks, stable budesonide
use in preciding 2 weeks, prednisone use <=15mg/day in preceding 2 weeks with a
mandatory taper of 5mg per week from week 4
• Women need to use reliable contraceptives during participation in the study
* Alkaline phosphatase >1.5x ULN in the subgroup of PSC/UC patients

Exclusion Criteria

• Condition leading to profound immunosuppression
o For example: HIV, infectious diseases leading to immunosuppression, bone
marrow malignancies
o Use of systemic chemotherapy
o Child-Pugh B liver cirrhosis
• Anti-TNF treatment in preceding 2 months
Vedolizumab, tofacitinib and/or ustekinumab treatment in preceding 2
months
• Cyclosporine treatment in preceding 4 weeks
• Use of Methotrexate in preceding 2 months
• Prednisolone dose > 15 mg/day in preceding 2 weeks
• Use of topical therapy in preceding 2 weeks
• Life expectancy < 12 months
• Difficulty with swallowing
• Use of systemic antibiotics in preceding 4 weeks
• Use of probiotic treatment in preceding 4 weeks
• Positive stool cultures for common enteric pathogens (Salmonella, Shigella,
Yersinia, Campylobacter, enteropathogenic e coli)
• Positive C. Difficile stool test
• Positive dual faeces test for pathogenic parasites e.g. Dientamoeba
histolytica, Giardia Lamblia, Dientamoeba fragilis..
• Positive serological test for HIV
• History of surgery:
o presence of a pouch
o presence of stoma
• Known intra-abdominal fistula
• Pregnancy or women who give breastfeeding
• Vasopressive medication, icu stay
• Signs of ileus, diminished passage
• Allergy to macrogol or substituents, eg peanuts, shellfish
* Allergy to gadolinium iv contrast agent in the subgroup of patients who
will be scheduled for MRI liver.
• Crohn*s disease
* Subject who has any conditions that in the opinion of the investigator,
would compromise the safety of the subject or the quality of the data and is an
unsuitable candidate for the study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of study subjects in clinical and<br /><br>endoscopic remission per adapted Mayo: stool frequency subscores (SFS) <= 1,<br /><br>rectal bleeding subscore (RBS)=0 and endoscopic subscore <= 1</p><br>

Secondary Outcome Measures