Transfer of Feces in Ulcerative Colitis 2

Phase 2

Recruiting

• Conditions: Ulcerative Colitis; Ulcerative Colitis Flare; Ulcerative Colitis Acute
• Interventions: Other: Fecal microbiota transplant

• Registration Number: NCT05998213
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis.

Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas).

Donors are selected based on microbiota profile.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-05
• Study First Submitted: 2023-07-12
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-16
• Last Update Submitted: 2023-08-16
• Study First Posted: 2023-08-18
• Last Update Posted: 2023-08-18
• Primary Completion: 2024-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Donor fecal microbiota transplant	Fecal microbiota transplant	-
Autologous fecal microbiota transplant	Fecal microbiota transplant	-

Primary Outcome Measures

Name	Time	Method
Clinical and endoscopic remission	week 8	per adapted Mayo: stool frequency subscores (SFS) ≤ 1, rectal bleeding subscore (RBS) =0 and endoscopic subscore ≤ 1.; The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score. A higher score reflects worse outcome.

Secondary Outcome Measures

Name	Time	Method
Endoscopic response, evaluated by sigmoidoscopy	week 8	•Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.
Clinical response	week 8	Adapted Mayo: decrease from baseline ≥ 2 points and ≥ 30% plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.; The adapted Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and endoscopic subscore) have a minimum of 0 and a maximum score of 3. The adapted Mayo score does not include PGA (physician global assessment), in contrary to the full Mayo score.

Trial Locations

Locations (1)

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands