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NCT01560819 · ClinicalTrials.gov registry record · Phase 1

Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases

A Phase 1 study of Inflammatory Bowel Disease (IBD), sponsored by Corewell Health West.

Completed
Registry status
Phase 1
Development phase
20
Enrollment target
1
Study location

NCT01560819 is a Phase 1 study of Inflammatory Bowel Disease (IBD) that has completed, run by Corewell Health West. The registered enrollment target is 20 participants, below the 272-participant average among 12 other Inflammatory Bowel Disease (IBD) trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01560819, a Phase 1 study of Inflammatory Bowel Disease (IBD), has completed, sponsored by Corewell Health West.

COMPLETED
Registry status
Phase 1
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantation (GMT), also known as fecal transplantation, has been used as a treatment option for Clostridium difficile colitis and UC. The literature supports strong evidence for the plausibility of using GMT for patients with IBD associated colitis, especially for patients with UC. This research will be conducted in the Helen DeVos Children's Hospital (HDVCH) Pediatric gastrointestinal outpatient clinic. A pilot study of ten patients will be conducted to evaluate if GMT improves clinical symptoms in patients with IBD. Patients with IBD colitis (UC and CD with colonic involvement only) will be approached for GMT as a treatment option for their disease. Each subject will undergo 5 sessions (1 session/day, and not necessarily on consecutive days) of GMT within a period of 10 days. Post treatment evaluation will be done at their regularly scheduled clinic follow up. Healthy donors \>18 years of age will be chosen by the family, inclusive of immediate family members and friends. Donors will be required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.

Conditions Studied

Inflammatory Bowel Disease (IBD)

Interventions

  • DRUG Gut Microbial Transplantation

Study Locations (1)

Michigan

  • Helen DeVos Children's Hospital of Spectrum Health Hospitals - Grand Rapids

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2012-03
Est. Completion 2013-06
Phase Phase 1

Sponsor

Corewell Health West

38 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01560819

The ClinicalTrials.gov registry entry for NCT01560819 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 12 other Inflammatory Bowel Disease (IBD) trials with a reported enrollment target (93% lower). The listed sponsor is Corewell Health West, which has 38 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Inflammatory Bowel Disease (IBD) appearing as the primary indexed condition, and to 1 intervention - of which Gut Microbial Transplantation is the first listed.

NCT01560819 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.

Frequently Asked Questions

What is clinical trial NCT01560819 about?

NCT01560819 is a clinical study titled "Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases". Inflammatory bowel disease (IBD) is a chronic, debilitating, relapsing inflammatory disorder affecting the gastrointestinal tract which does not have a medical cure. IBD consists of 2 different forms: Crohn's Disease (CD) and Ulcerative Colitis (UC). In the last 2 decades, Gut Microbial Transplantat...

What is the current status of trial NCT01560819?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2012-03. Estimated completion is 2013-06.

What conditions does trial NCT01560819 study?

This clinical trial studies the following conditions: Inflammatory Bowel Disease (IBD).

What interventions are being tested in trial NCT01560819?

The interventions under investigation include: Gut Microbial Transplantation (DRUG).

Who is sponsoring clinical trial NCT01560819?

This trial is sponsored by Corewell Health West, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01560819 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.