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NCT05998213CompletedPhase 2

Transfer of Feces in Ulcerative Colitis 2

Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy

Source: ClinicalTrials.gov · Last updated 20 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
85 (actual)
First submitted
12 Jul 2023
Start date
12 Jun 2020
Primary completion date
10 Jan 2025
Lead sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
NCT number
NCT05998213

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 85
  • From 12 Jun 2020 to the primary completion date, 10 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Use of topical therapy in preceding 2 weeks
  • Vasopressive medication, icu stay

Other illness

  • 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
  • Positive serological test for HIV
  • History of surgery:
    • presence of a pouch
    • presence of stoma
  • Known intra-abdominal fistula
  • 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

Other

  • 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
  • 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.
  • Pregnancy or women who give breastfeeding
  • Signs of ileus, diminished passage

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Amsterdam University Medical Center
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.