Transfer of Feces in Ulcerative Colitis 2

NCT ID: NCT05998213

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-05
• Study Completion Date: 2025-12-01

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.

Conditions

Ulcerative Colitis; Ulcerative Colitis Flare; Ulcerative Colitis Acute

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Donor fecal microbiota transplant

Group Type: EXPERIMENTAL

Fecal microbiota transplant

Intervention Type: OTHER

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

Autologous fecal microbiota transplant

Group Type: PLACEBO_COMPARATOR

Fecal microbiota transplant

Intervention Type: OTHER

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

Interventions

Fecal microbiota transplant

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

Intervention Type: OTHER

Other Intervention Names

FMT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Cyriel Y Ponsioen

prof. dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Cyriel Ponsioen, prof.

Role: CONTACT

c.y.ponsioen@amsterdamumc.nl

+31 20 5668278

Melanie Benard, Msc

Role: CONTACT

m.v.benard@amsterdamumc.nl

0031645050314

Facility Contacts

Melanie V. Bénard, Msc

Role: primary

m.v.benard@amsterdamumc.nl

Florine Jiwa

Role: backup

f.h.jiwa@amsterdamumc.nl

Other Identifiers

NL65069.018.18

Identifier Type: -

Identifier Source: org_study_id