Transfer of Feces in Ulcerative Colitis 2

Ulcerative Colitis Clinical Trial

— TURN2  

Official title:

Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05998213
• Other study ID #: NL65069.018.18
• Status: Recruiting
• Phase: Phase 2
• Start date: December 5, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Cyriel Ponsioen, prof.
• Phone: +31 20 5668278
• Email: c.y.ponsioen[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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-TNFa 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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis
• Ulcerative Colitis Acute
• Ulcerative Colitis Flare

Intervention

Other:
• Fecal microbiota transplant
Frozen FMT via duodenal tube (2 times) and enemas (4 times)

Locations

Country	Name	City	State
Netherlands	Amsterdam University Medical Center	Amsterdam	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	UMC Utrecht, University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical and endoscopic remission	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.	week 8
Secondary	Clinical response	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.	week 8
Secondary	Endoscopic response, evaluated by sigmoidoscopy	•Proportion of patients with =1 point reduction in summed endoscopic Mayo score of both the rectum and sigmoid.	week 8