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Completed

NCT Number: NCT05998213

Transfer of Feces in Ulcerative Colitis 2

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Amsterdam University Medical Center

Amsterdam, North Holland, 1061BK, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal microbiota transplant

Other

Frozen FMT via duodenal tube (2 times) and enemas (4 times)

Other names: FMT

Primary outcomes

  1. Clinical and endoscopic remission

    Time frame: 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 outcomes

  1. Clinical response

    Time frame: 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.

  2. Clinical improvement

    Time frame: week 8

    Partial adapted Mayo: a decrease from baseline ≥1 points and ≥30%, plus a decrease in RBS ≥1 or an absolute RBS ≤1.

    The partial adapted Mayo score has a minimum score of 0 and a maximum score of 6. The 2 subscores (SFS, RBS) have a minimum of 0 and a maximum score of 3. The partial adapted Mayo score does not include PGA (physician global assessment) and endoscopic subscore, in contrary to the full Mayo score.

  3. Clinical remission

    Time frame: week 8

    Full mayo score: a decrease from baseline of ≤2 points with no subscore >1

  4. Complete remission

    Time frame: week 8

    Full Mayo score: ≤2 points reduction from baseline with no subscore >1, and an rectal bleeding score and endoscopic subscore of 0

  5. Sustained steroid-free remission

    Time frame: week 52

    Adapted Mayo: SFS ≤1, RBS =0, endoscopic subscore ≤1, and no need for rescue therapy until week 52.

    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.

  6. Endoscopic complete remission

    Time frame: week 8

    Proportion of patients with Endoscopic subscore = 0

  7. Endoscopic improvement

    Time frame: week 8

    Proportion of patients with Endoscopic subscore of 0 or 1

  8. Endoscopic response, evaluated by sigmoidoscopy

    Time frame: week 8

    •Proportion of patients with ≥1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.

  9. Histological remission

    Time frame: week 8

    Proportion of patients with Nancy Histological Index (NHI): NHI ≤1

  10. SCCAI

    Time frame: week 1, 2, 3, 4, 8, 18, 39, and 52

    Change in SCCAI score from baseline

  11. Partial Mayo score

    Time frame: week 1, 2, 3, 4, 8, 18, 39, and 52

    Change in partial mayo score from baseline. The partial Mayo score has a minimum score of 0 and a maximum score of 9. The 3 subscores (SFS, RBS, and PGA) have a minimum of 0 and a maximum score of 3. The partial Mayo score does not include endoscopic subscore, in contrary to the full Mayo score.

  12. IBD-Control

    Time frame: week 2, 4, 8, 18, 39, and 52

    Change in IBD-Control score from baseline

  13. Adverse events

    Time frame: week 8

    Occurence of adverse events

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Collaborators

  • UMC Utrecht
  • University Medical Center Groningen

Registry information

Official study title

Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy

Acronym: TURN2

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 18, 2023
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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