Official Title

Bacteriotherapy in Pediatric Inflammatory Bowel Disease
  • Phase

    Phase 1
  • Study Type

  • Study Participants

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.
Study Started
Dec 31
Primary Completion
Oct 31
Study Completion
Jan 31
Results Posted
May 25
Last Update
May 30

Biological Bacteriotherapy

Bacteriotherapy Experimental

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


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



All Events

Event Type Organ System Event Term Bacteriotherapy

Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease Activity Index (PCDAI) Scoring

The primary outcome measure is based on estimating the responder rate. This is defined as the proportion of patients with response to therapy by a drop of 10 or more points in PUCAI/PCDAI scoring. PUCAI/PCDAI are validated activity indexes for pediatric Ulcerative colitis and Crohn's disease, respectively. PUCAI scoring ranges from 0 to 85, with disease remission less than 10, mild disease activity between 10 - 35, moderate disease activity from 35 - 65, and severe disease activity above 65. PCDAI scoring ranges from 0 to 100; with remission being less than 10, mild disease from 10 to 30, and moderate to severe disease greater than 30.





Age, Categorical

Sex: Female, Male

Overall Study

Bacteriotherapy: Crohn's Disease

Bacteriotherapy: Ulcerative Colitis