A Study to Evaluate Fecal Microbiota Transplantation Engraftment in IBS

Beth Israel Lahey Health

Status and phase: Completed; Phase 1

Conditions: Irritable Bowel Syndrome

Treatments: Procedure: FMT with antibiotic pre-treatment (v2); Procedure: FMT with antibiotic pre-treatment (v1); Drug: placebo fecal microbiota transplantation; Procedure: fecal microbiota transplantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02847481

2015P000211

Details and patient eligibility

About

This is a randomized pilot study to characterize engraftment of a donor's microflora onto patients with Irritable Bowel Syndrome with diarrhea following fecal microbiota transplantation.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• IBS with diarrhea

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

fecal microbiota transplantation

Experimental group

Description:

fecal microbiota transplantation

Treatment:

Procedure: fecal microbiota transplantation

placebo fecal microbiota transplantation

Placebo Comparator group

Description:

placebo fecal microbiota transplantation

Treatment:

Drug: placebo fecal microbiota transplantation

FMT after antibiotic pretreatment v1

Experimental group

Description:

fecal microbiota transplantation after antibiotic pretreatment

Treatment:

Procedure: FMT with antibiotic pre-treatment (v1)

Procedure: fecal microbiota transplantation

FMT after antibiotic pretreatment v2

Experimental group

Description:

fecal microbiota transplantation after antibiotic pretreatment

Treatment:

Procedure: FMT with antibiotic pre-treatment (v2)

Procedure: fecal microbiota transplantation