Transfer of Feces in Ulcerative Colitis 2

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · Aug 16, 2023

Keywords

ClinConnect Summary

This clinical trial, called the Transfer of Feces in Ulcerative Colitis 2, is looking at a potential treatment for people with ulcerative colitis, a condition that causes inflammation in the colon. The study aims to see how effective and safe a special treatment called fecal microbiota transplantation (FMT) is, where healthy donor stool is used to help restore the balance of good bacteria in the gut. Participants will receive four treatments, using both a tube placed in the stomach and enemas, to deliver the donor stool.

To join the trial, participants must be between 18 and 70 years old, have a confirmed diagnosis of ulcerative colitis affecting the left side of the colon, and meet certain health criteria. Participants can expect to be monitored throughout the study, and they will need to follow specific health guidelines, like maintaining a stable dosage of certain medications. The trial is currently recruiting participants, and it’s important to note that individuals with certain health conditions or treatments may not be eligible, as the study aims to ensure safety and accurate results.

Gender

ALL

Eligibility criteria

• 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
• • 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 screening sigmoidoscopy
• • 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 per week 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 Criteria:
• • Condition leading to profound immunosuppression
• • For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies
• • 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 microscopically many 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 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