Bacteriotherapy in Pediatric Inflammatory Bowel Disease

David Suskind

Status and phase: Completed; Phase 1

Conditions: CD; Inflammatory Bowel Disease; Ulcerative Colitis; Crohn's Disease

Treatments: Biological: Bacteriotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01757964

14267

Details and patient eligibility

About

In this study, the investigators want to see if Bacteriotherapy (also referred to as stool transplantation) improves the symptoms and decreases inflammation in children with Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis. Additionally, researchers want to learn whether this experimental therapy delays the need for starting additional medications to treat pediatric IBD.

Enrollment: 13 patients

Sex: All

Ages: 12 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis or Crohn's Disease
• Willing parent to donate stool for the transplant

Exclusion criteria

• Severe Disease
• History of intra-abdominal abscess, intra-abdominal fistula or stricturing
• History of other systemic diseases
• The patient has received TNF inhibitors to treat their IBD within two months of transplant

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Bacteriotherapy

Experimental group

Description:

Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.

Treatment:

Biological: Bacteriotherapy