Plain-English translation of NCT04970446 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1/2 — A combined trial that checks safety and dosing while also starting to look at whether the treatment works.
This trial is testing fecal microbiota transplantation () — a treatment that transfers healthy bacteria from a donor into your digestive system — to see if it can help control active Crohn's disease inflammation. You'll either receive the active treatment or a placebo (inactive liquid), and researchers will track your symptoms and inflammation markers over several months to see if the medication reduces your disease activity.
Crohn's disease involves an imbalance in the bacteria living in your gut, and current treatments don't work well enough for everyone. This trial is exploring whether restoring healthy bacteria through this treatment could offer a new way to help people achieve remission and control their symptoms.
You likely qualify if…
You likely don't qualify if…
The trial has multiple phases over about a year. First, you'll go through an optimization phase to prepare your body. Then you'll be randomly assigned to receive either the active microbial transplant or a placebo, given as a liquid formulation. At week 8, if you show improvement, you may continue into a maintenance phase for an additional 44 weeks. Throughout the trial, you'll have regular visits for endoscopic procedures, blood tests, and symptom assessments to measure how well the treatment is working.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
Australia
Phase
Safety & dosing / Early efficacy
Sponsor
St Vincent's Hospital Melbourne
Collaborators
The Queen Elizabeth Hospital, BiomeBank Adelaide
Enrollment target
~120 participants
Started
May 2022
Primary completion
April 2025
This trial's estimated completion date has passed — the record may not be fully up to date.
Age range
18 Years – 70 Years
Last updated on clinicaltrials.gov in February 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Amy Wilson O'Brien
St Vincents Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.