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Microbial Restoration in Inflammatory Bowel Diseases

NCT04970446 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-02-26

No results posted yet for this study

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.

Conditions

  • Fecal Microbiota Transplantation
  • Crohn Disease
  • Inflammatory Bowel Diseases
  • Microbiome

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.

Sponsors & Collaborators

  • The Queen Elizabeth Hospital

    collaborator OTHER

  • BiomeBank Adelaide

    collaborator UNKNOWN

  • The University of Queensland

    collaborator OTHER

  • Monash University

    collaborator OTHER

  • St Vincent's Hospital Melbourne

    lead OTHER

Principal Investigators

  • Michael A Kamm, MD · St Vincents Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-01
Primary Completion
2025-04-01
Completion
2026-04-01

Countries

  • Australia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04970446 on ClinicalTrials.gov