NCT04970446 Microbial Restoration in Inflammatory Bowel Diseases
| NCT ID | NCT04970446 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | St Vincent's Hospital Melbourne |
| Condition | Fecal Microbiota Transplantation |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2022-05-01 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, two-centre, double-blind, parallel-arm, randomised, placebo-controlled trial evaluating the impact of FMT on patients with active Crohn's disease.
Eligibility Criteria
Inclusion Criteria: Active Crohn's disease * Confirmed endoscopic active inflammation (unless isolated small bowel disease that is inaccessible by endoscopy in which case sonographic inflammation is sufficient) within 6 months of study entry AND * CDAI score of 220-450 AND * One of the following: * CRP ≥5mg/L * faecal calprotectin ≥100μg/g * inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging) * Willing and able to attend the study sites for regular endoscopic procedures. Exclusion Criteria: Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \>20mg or budesonide dose \>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.
Contact & Investigator
Michael A Kamm, MD
PRINCIPAL INVESTIGATOR
St Vincents Hospital
Frequently Asked Questions
Who can join the NCT04970446 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Fecal Microbiota Transplantation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04970446 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04970446 currently recruiting?
Yes, NCT04970446 is actively recruiting participants. Contact the research team at amy.wilson-obrien@svha.org.au for enrollment information.
Where is the NCT04970446 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT04970446 clinical trial?
NCT04970446 is sponsored by St Vincent's Hospital Melbourne. The principal investigator is Michael A Kamm, MD at St Vincents Hospital. The trial plans to enroll 120 participants.