Microbial Restoration in Inflammatory Bowel Diseases
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSt Vincent's Hospital Melbourne
About this trial
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
Qualifiers
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
CRP ≥5mg/L
faecal calprotectin ≥100μg/g
Disqualifiers
None
Trial design
Treatments tested in this trial
- Antibiotics
- Dietician designed diet
- FMT
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
St Vincent's Hospital Melbourne
Lead sponsor
The Queen Elizabeth Hospital
Collaborator
BiomeBank Adelaide
Collaborator
The University of Queensland
Collaborator
Monash University
Collaborator
Source ClinicalTrials.gov