Health TrialsbyHealthPanel

Microbial Restoration in Inflammatory Bowel Diseases

ConditionsFecal Microbiota TransplantationCrohn DiseaseInflammatory Bowel DiseasesMicrobiome
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Antibiotics

    Drug

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

  • Dietician designed diet

    Dietary supplement

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

  • FMT

    Drug

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

  • Placebo

    Other intervention

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

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: FMT armActive comparator 3 interventions
Group B: Placebo armPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Clinical response

CDAI decrease of ≥100 or CDAI\<150

Time frame
Week 8

Secondary outcomes

1

Clinical remission

CDAI \<150

Time frame
Week 8 and week 52 or Week 16 and week 60 (for open FMT group)
2

Endoscopic response

SES-CD reduction by 25% and 50%

Time frame
Week 8 and 52 or Week 16 and 60
3

Endoscopic remission

SES-CD ≤2 or absence of ulcers

Time frame
Week 8 and week 52 Week 16 and 60
4

Histological Remission

The absence of ulcers; the absence of acute inflammation histologically; one of either Geboes Score or Robarts Histology Index

Time frame
Week 8 and 52 or Week 16 and 60

Other outcomes

Sponsors and contacts

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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
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