Phase
Condition
Crohn's Disease
Colic
Ulcerative Colitis
Treatment
Fecal microbiota transplant
Clinical Study ID
Ages 18-70 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 and <70
Ability to give informed consent
Established ulcerative colitis with known involvement of the left colon according tothe Lennard-Jones criteria
Partial mayo score of ≥ 3 and calprotectin > 250
Full Mayo score 5-9
Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screeningsigmoidoscopy
Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks.
Stable dose of budesonide in preceding 2 weeks.
Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg perweek starting from week 4.
Women need to use reliable contraceptives during participation in the study
Alkaline phosphatase > 1.5 x ULN in the subgroup of PSC/UC patients.
Exclusion
Exclusion Criteria:
Condition leading to profound immunosuppression
For example: HIV, infectious diseases leading to immunosuppression, bone marrowmalignancies
Use of systemic chemotherapy
Child-Pugh B liver cirrhosis
Anti-TNFα treatment in preceding 2 months
Vedolizumab treatment in preceding 2 months
Tofacitinib treatment in preceding 2 months
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, Blastocystis hominis only if microscopicallymany or very many blastocysts are seen.
Positive serological test for HIV
History of surgery:
presence of a pouch
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
Known allergy to iv gadolinium in the subgroup of patients who would be scheduledfor MRI liver
Crohn's disease
Subject who has any conditions that in the opinion of the investigator, wouldcompromise the safety of the subject or the quality of the data and is an unsuitablecandidate for the study
Study Design
Connect with a study center
Amsterdam University Medical Center
Amsterdam, North Holland 1061BK
NetherlandsSite Not Available

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