Transfer of Feces in Ulcerative Colitis 2

Last updated: March 18, 2026
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Overall Status: Completed

Phase

2

Condition

Crohn's Disease

Colic

Ulcerative Colitis

Treatment

Fecal microbiota transplant

Clinical Study ID

NCT05998213
NL65069.018.18
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

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

Total Participants: 85
Treatment Group(s): 1
Primary Treatment: Fecal microbiota transplant
Phase: 2
Study Start date:
June 12, 2020
Estimated Completion Date:
December 18, 2025

Connect with a study center

  • Amsterdam University Medical Center

    Amsterdam, North Holland 1061BK
    Netherlands

    Site Not Available

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