Microbial Restoration in Inflammatory Bowel Diseases

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

May 1, 2022

Primary Completion Date

April 1, 2025

Study Completion Date

April 1, 2026

Conditions
Fecal Microbiota TransplantationCrohn DiseaseInflammatory Bowel DiseasesMicrobiome
Interventions
DRUG

Antibiotics

All patients will receive a one week course of antibiotic therapy.

DIETARY_SUPPLEMENT

Dietician designed diet

All patients will be recommended dietary modification 3 weeks prior to, and during, the study.

DRUG

FMT

Anaerobically prepared stool. Dosing will vary according to mode of administration.

OTHER

Placebo

Placebo will contain food colourant, 0.9% normal saline and glycerol.

Trial Locations (1)

3004

RECRUITING

St Vincents Hospital, Melbourne

All Listed Sponsors
collaborator

The Queen Elizabeth Hospital

OTHER

collaborator

BiomeBank Adelaide

UNKNOWN

collaborator

The University of Queensland

OTHER

collaborator

Monash University

OTHER

lead

St Vincent's Hospital Melbourne

OTHER

NCT04970446 - Microbial Restoration in Inflammatory Bowel Diseases | Biotech Hunter | Biotech Hunter