Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease

Last updated: March 6, 2014
Sponsor: Children's Mercy Hospital Kansas City
Overall Status: Completed

Phase

3

Condition

Bowel Dysfunction

Ulcerative Colitis

Colic

Treatment

N/A

Clinical Study ID

NCT00944736
09 06-115
  • Ages 11-17
  • All Genders

Study Summary

The purpose of this study is to determine the effect of a probiotic formulation, VSL#3, on intestinal permeability in pediatric patients with Crohn's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current diagnosis of small bowel or colonic Crohn's disease as defined by histologicaland endoscopic criteria.

  • Males or females ages 11-17 years.

  • Crohn's disease in remission as defined by a Pediatric Crohn's Disease Activity Index (PCDAI) < 10

  • Patients on maintenance doses of aminosalicylates, 6-MP and/or Azathioprine for atleast 2 months.

  • Procurement of written informed consent signed by the subject's legal guardian andstudy investigator(s) and patient assent.

Exclusion

Exclusion Criteria:

  • Patients with documented intestinal stricture.

  • Patients with signs of symptoms of systemic or intestinal infection.

  • Antibiotic use the previous 1 month.

  • Probiotic use in the previous 2 months (excluding yogurt).

  • Use of the following medications; Methotrexate, Cyclosporine, Tacrolimus andInfliximab.

  • Patients with diagnosis of other co-morbid diseases such as heart disease, renaldisease, immunodeficiency, diabetes, or thyroid disease.

  • Patients with indwelling catheters.

  • Patients with short bowel syndrome

  • Positive urine pregnancy test for female subjects

Study Design

Total Participants: 12
Study Start date:
July 01, 2009
Estimated Completion Date:
July 31, 2013

Study Description

Children with Crohn's disease have altered intestinal permeability. A pilot study in children showed that probiotics may decrease intestinal permeability. In this double blind, randomized controlled trial, we will observe the effect of VSL#3 on small bowel permeability using a double sugar absorption test. PCDAI was monitored, but not analyzed.

Connect with a study center

  • The Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Site Not Available

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