Transfer of Feces in Ulcerative Colitis 2 (TURN2)

• ClinicalTrials.gov Identifier: NCT05998213
• Recruitment Status: Recruiting
• First Posted: August 18, 2023
• Last Update Posted: August 18, 2023
• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Collaborators: University Medical Center Groningen; UMC Utrecht
• Information provided by (Responsible Party): Cyriel Y Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Tracking Information

• First Submitted Date: July 12, 2023
• First Posted Date: August 18, 2023
• Last Update Posted Date: August 18, 2023
• Actual Study Start Date: December 5, 2018
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 16, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 16, 2023)

• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transfer of Feces in Ulcerative Colitis 2
• Official Title: Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy

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 Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Ulcerative Colitis
• Ulcerative Colitis Flare
• Ulcerative Colitis Acute

Intervention

Other: Fecal microbiota transplant

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

Other Name: FMT

Study Arms

• Experimental: Donor fecal microbiota transplant
  Intervention: Other: Fecal microbiota transplant
• Placebo Comparator: Autologous fecal microbiota transplant
  Intervention: Other: Fecal microbiota transplant

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 16, 2023): 76
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 1, 2025
• Estimated Primary Completion Date: December 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Cyriel Ponsioen, prof.; +31 20 5668278; c.y.ponsioen@amsterdamumc.nl

Contact: Melanie Benard, Msc; 0031645050314; m.v.benard@amsterdamumc.nl

• Listed Location Countries: Netherlands

Administrative Information

• NCT Number: NCT05998213
• Other Study ID Numbers: NL65069.018.18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Supporting Materials: Study Protocol

• Current Responsible Party: Cyriel Y Ponsioen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Original Responsible Party: Same as current
• Current Study Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Original Study Sponsor: Same as current

Collaborators

• University Medical Center Groningen
• UMC Utrecht

• Investigators: Not Provided
• PRS Account: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Verification Date: August 2023