Bacteriotherapy in Pediatric Inflammatory Bowel Disease

NCT ID: NCT01757964

Last Updated: 2017-05-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Bowel Disease Crohn's Disease Ulcerative Colitis CD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bacteriotherapy

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

Group Type EXPERIMENTAL

Bacteriotherapy

Intervention Type BIOLOGICAL

Interventions

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Bacteriotherapy

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Children's Hospital

OTHER

Sponsor Role collaborator

David Suskind

OTHER

Sponsor Role lead

Responsible Party

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David Suskind

Associate Professor of Pediatrics

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Suskind DL, Brittnacher MJ, Wahbeh G, Shaffer ML, Hayden HS, Qin X, Singh N, Damman CJ, Hager KR, Nielson H, Miller SI. Fecal microbial transplant effect on clinical outcomes and fecal microbiome in active Crohn's disease. Inflamm Bowel Dis. 2015 Mar;21(3):556-63. doi: 10.1097/MIB.0000000000000307.

Reference Type RESULT
PMID: 25647155 (View on PubMed)

Suskind DL, Singh N, Nielson H, Wahbeh G. Fecal microbial transplant via nasogastric tube for active pediatric ulcerative colitis. J Pediatr Gastroenterol Nutr. 2015 Jan;60(1):27-9. doi: 10.1097/MPG.0000000000000544.

Reference Type RESULT
PMID: 25162366 (View on PubMed)

Other Identifiers

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14267

Identifier Type: -

Identifier Source: org_study_id

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