Microbial Restoration in Inflammatory Bowel Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2026-04-01

Brief Summary

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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.

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Detailed Description

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The study will be conducted in two parts. The first part will involve all patients undergoing an optimisation phase, followed by randomisation into either intervention or placebo arms of the induction phase of the study. For patients achieving a pre-determined clinical response threshold at week 8 they will be re-randomised into the maintenance phase of the trial for a further 44 weeks.

FMT will be anaerobically prepared, freeze-thawed for administration.

Conditions

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Fecal Microbiota Transplantation Crohn Disease Inflammatory Bowel Diseases Microbiome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, two clinical center, parallel-arm, randomised, double-blind, placebo-controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomisation tables will be computer generated by an independent statistician. The indistinguishable aspect of the FMT syringes (colour, packaging) will ensure the blindness of both patients and physicians in charge.

Study Groups

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FMT arm

Anaerobically prepared, freeze-thawed faecal microbiota transplantation

Group Type ACTIVE_COMPARATOR

Antibiotics

Intervention Type DRUG

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

Dietician designed diet

Intervention Type DIETARY_SUPPLEMENT

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

FMT

Intervention Type DRUG

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

Placebo arm

Placebo liquid formulation (normal saline, glycerol, food colorant)

Group Type PLACEBO_COMPARATOR

Antibiotics

Intervention Type DRUG

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

Dietician designed diet

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type OTHER

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

Interventions

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Antibiotics

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

Intervention Type DRUG

Dietician designed diet

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

Intervention Type DIETARY_SUPPLEMENT

FMT

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Active Crohn's disease

* 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
* One of the following:

* CRP ≥5mg/L
* faecal calprotectin ≥100μg/g
* inflammation on imaging (either intestinal ultrasound or magnetic resonance imaging)
* Willing and able to attend the study sites for regular endoscopic procedures.

Exclusion Criteria

Active perianal or fistulising disease; Pregnant or intending to become pregnant within 12 months; Enteropathy or colitis other than Crohn's disease; Symptomatic intestinal stricture likely to require surgical treatment; Presence of a stoma; Presence of an ileoanal pouch; Total white cell count less than 3.0 x 109/L; Albumin less than 20g/L; Immunodeficiency (beyond that caused by immune suppressants used for the treatment of IBD) e.g. HIV or Common variable immune deficiency; Anaphylaxis/severe allergy to food; Thiopurine, methotrexate, biologic agent or small molecule inhibitors or aminosalicylates whose dose has been modified within the past two months, 1 month and two weeks of study entry, respectively; Prebiotic, probiotic or antibiotic therapy, or over-the-counter supplements therapy in the two weeks prior to study entry; Rectal topical Crohn's disease therapy in the 2 weeks prior to study entry; Prednisolone dose \>20mg or budesonide dose \>6mg; Unwilling or unable to taper corticosteroids to zero within 8 weeks of initial FMT; Active gastrointestinal infection; Alcohol consumption of a dependent nature; Primary sclerosing cholangitis; Any condition that the treating gastroenterologist deems to pose a theoretical risk to the patient undertaking FMT; Any patient that the treating clinicians feel is incapable of participating in the safe use of FMT.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No