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Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Bacteriotherapy

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease focused on measuring Crohns Disease, Ulcerative Colitis, Inflammatory Bowel Disease, IBD

Eligibility Criteria

12 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bacteriotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01757964

First Posted

December 22, 2012

Last Updated

April 25, 2017

Sponsor

David Suskind

Collaborators

Seattle Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01757964

Brief Title

Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Official Title

Bacteriotherapy in Pediatric Inflammatory Bowel Disease

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

David Suskind

Collaborators

Seattle Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis, CD

Keywords

Crohns Disease, Ulcerative Colitis, Inflammatory Bowel Disease, IBD

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bacteriotherapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Bacteriotherapy

Primary Outcome Measure Information:

Title

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

Description

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25647155

Citation

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.

Results Reference

result

PubMed Identifier

25162366

Citation

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.

Results Reference

result

Learn more about this trial

Bacteriotherapy in Pediatric Inflammatory Bowel Disease

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