Fecal microbiota transplantation for ulcerative colitis
Transfer of Feces in Ulcerative Colitis 2; Improving Efficacy
PHASE2 · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05998213
This study is testing whether a new type of stool transplant can help people with ulcerative colitis feel better compared to using their own stool.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Drugs / interventions | Vedolizumab, Ustekinumab, Tofacitinib, chemotherapy, Methotrexate, Prednisone |
| Locations | 1 site (Amsterdam, Noord-Holland) |
| Trial ID | NCT05998213 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patients with ulcerative colitis. Participants will receive four treatments involving frozen FMT administered through both upper and lower gastrointestinal routes. The study is placebo-controlled and randomized, ensuring a rigorous assessment of the treatment's effectiveness. Donors are selected based on their microbiota profile to optimize the potential benefits of the transplantation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with established ulcerative colitis and specific severity criteria.
Not a fit: Patients with conditions leading to profound immunosuppression or those currently on anti-TNFα treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of ulcerative colitis and reduce flare-ups for patients.
How similar studies have performed: Previous studies have shown promise in fecal microbiota transplantation for various gastrointestinal conditions, suggesting potential success for this approach in ulcerative colitis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam, Noord-Holland
- Amsterdam University Medical Center — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Cyriel Ponsioen, prof.
- Email: c.y.ponsioen@amsterdamumc.nl
- Phone: +31 20 5668278
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ulcerative Colitis, Ulcerative Colitis Flare, Ulcerative Colitis Acute