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Microbial Restoration in Inflammatory Bowel Diseases

PHASE2PHASE3RECRUITING

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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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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Active Crohn's disease

Exclusion criteria

Active perianal or fistulising disease

Pregnant

Enteropathy or colitis other than Crohn's disease

Symptomatic stricture likely to require surgical treatment

Presence of a stoma

Presence of an ileoanal pouch

Immunodeficiency (beyond that caused by immune suppressants used with IBD) e.g. HIV or Common variable immune deficiency

Prednisolone dose >20mg or budesonide dose >6mg

Active gastrointestinal infection

Alcohol consumption of a dependent nature

Primary sclerosing cholangitis

Recent overseas travel

Contact with COVID-19 positive or DHHS-defined close contact of COVID-19 positive individual in 8 weeks prior to study entry

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-12-01

Primary completion: 2024-12-01

Study completion finish: 2025-12-01

Study type

TREATMENT

Phase

PHASE2

PHASE3

Trial 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

Image related to Fecal Microbiota Transplantation

Condition: Fecal Microbiota Transplantation, Crohn Disease and more
DRUG: Antibiotics and other drugs
Melbourne, Victoria, Australia
Sponsor: St Vincent's Hospital Melbourne

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincents Hospital

Research sites nearby

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St Vincents Hospital
Melbourne, Victoria, Australia

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 Anaerobically prepared, freeze-thawed faecal microbiota transplantation	DRUG: Antibiotics All patients will receive a one week course of antibiotic therapy.
PLACEBO_COMPARATOR: Placebo arm Placebo liquid formulation (normal saline, glycerol, food colorant)	DRUG: Antibiotics All patients will receive a one week course of antibiotic therapy.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Clinical response	CDAI decrease of ≥100 or CDAI\<150	Week 8

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Microbial Restoration in Inflammatory Bowel Diseases