Microbial Restoration in Inflammatory Bowel Diseases
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
- CDAI score of 220-450
- 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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE1PHASE2
Study ID
NCT04970446
Intervention or treatment
DRUG: Antibiotics
DIETARY_SUPPLEMENT: Dietician designed diet
DRUG: FMT
OTHER: Placebo
Conditions
- Fecal Microbiota Transplantation
- Crohn Disease
- Inflammatory Bowel Diseases
- Microbiome
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
St Vincents Hospital
Select from list below to view details:
St Vincents Hospital
Melbourne, Victoria, Australia
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Who is running the clinical trial?
St Vincent's Hospital Melbourne
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: FMT arm
| Drug: Antibiotics, Dietary Supplement: Dietician designed diet, Drug: FMT |
PLACEBO_COMPARATOR: Placebo arm
| Drug: Antibiotics, Dietary Supplement: Dietician designed diet, Other: Placebo |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | CDAI decrease of ≥100 or CDAI\<150 | Week 8 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission | CDAI \<150 | Week 8 and week 52 or Week 16 and week 60 (for open FMT group) |
| Endoscopic response | SES-CD reduction by 25% and 50% | Week 8 and 52 or Week 16 and 60 |
| Endoscopic remission | SES-CD ≤2 or absence of ulcers | Week 8 and week 52 Week 16 and 60 |
| Histological Remission | The absence of ulcers; the absence of acute inflammation histologically; one of either Geboes Score or Robarts Histology Index | Week 8 and 52 or Week 16 and 60 |
| Radiological remission | IUS (BWT \<3mm and/or Limberg 0 or 1) or MRI (Wall thickness \<4mm and no or minimal wall enhancement) | Week 8 and 52 or Week 16 and 60 |
| Biochemical response | Normalisation of CRP and faecal calprotectin (\<50ug/g, \<100ug/g, \<150ug/g, \<200ug/g, \<250ug/g | Week 8 and 52 or Week 16 and 60 |
| Time to outcomes | Time taken to achieve clinical response or remission during induction and maintenance phases | Duration of trial |
| Maintenance of clinical remission | CDAI \<150 | Weeks 52 or 60 |
| Sustained clinical remission | CDAI \<150 | Weeks 52 or 60 |
| Steroid-free clinical remission | Steroid-free clinical remission | Weeks 52 or 60 |
| Safety outcomes | Adverse events | Duration of trial |
| Scientific outcomes | Comparison of genetic, microbiological, metabolic and immunologic factors in the responders with the non-responders | Week 8 and 52 or Week 16 and 60 |
References
Clinical Trials Gov: Microbial Restoration in Inflammatory Bowel DiseasesOther trials to consider
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