NCT01757964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 25, 2016

Completed
Last Updated

May 30, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

December 22, 2012

Results QC Date

November 16, 2015

Last Update Submit

April 25, 2017

Conditions

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative ColitisCD

Keywords

Crohns DiseaseUlcerative ColitisInflammatory Bowel DiseaseIBD

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Study Arms (1)

Bacteriotherapy

EXPERIMENTAL

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

Biological: Bacteriotherapy

Interventions

BacteriotherapyBIOLOGICAL
Bacteriotherapy

Eligibility Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (2)

  • 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.

    PMID: 25647155RESULT

  • 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.

    PMID: 25162366RESULT

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Results Point of Contact

Title
David Suskind MD Professor of Pediatrics
Organization
University of Washington
Jani.Klien@seattlechildrens.org
206-987-2521

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

December 22, 2012

First Posted

December 31, 2012

Study Start

December 1, 2012

Primary Completion

October 1, 2013

Study Completion

January 1, 2015

Last Updated

May 30, 2017

Results First Posted

May 25, 2016

Record last verified: 2017-04

Locations

US(1)