NCT02272868

Brief Summary

This is a double blind placebo control trial of fecal microbial transplantation for active Crohn's disease in patients 12 to 21 years of age.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

October 16, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 23, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

October 16, 2014

Last Update Submit

September 23, 2021

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

  • Pediatric Crohn's Disease Activity Index

    Clinical disease activity index in Crohn's disease

    12 weeks

Study Arms (2)

Fecal microbiome transplant

EXPERIMENTAL

Pretransplant(Rifaximin 400mg tid x 10 days + omeprazole 20 mg night before transplant and day of transplant + miralax 17g tid x 2 days) + Fecal Microbial Transplant

Biological: Fecal Microbial transplantDrug: rifaximin+omeprazole+miralax

Normal saline

PLACEBO COMPARATOR

Pretransplant(Rifaximin 400mg tid x 10 days + omeprazole 20 mg night before transplant and day of transplant + miralax 17g tid x 2 days) + Normal saline

Drug: Normal SalineDrug: rifaximin+omeprazole+miralax

Interventions

Fecal Microbial transplantBIOLOGICAL

Pretransplant regimen(rifaxamin+omeprazole+miralax) + Donor feces transplant

Fecal microbiome transplant
Normal SalineDRUG

Pretransplant regimen(rifaximin+omeprazole+miralax) +Normal Saline

Normal saline
rifaximin+omeprazole+miralaxDRUG
Fecal microbiome transplantNormal saline

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • David Suskind, MD

    Seattle Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2014

First Posted

October 23, 2014

Study Start

January 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations

US(1)