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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00944736
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : March 10, 2014
VSL Pharmaceuticals
Information provided by (Responsible Party):
Julia Bracken, Children's Mercy Hospital Kansas City

Brief 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.

Condition or disease Intervention/treatment Phase
Crohn's Disease Dietary Supplement: VSL#3 Dietary Supplement: Placebo Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission
Study Start Date : July 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: VSL#3 Dietary Supplement: VSL#3
1 packet BID
Placebo Comparator: Placebo Dietary Supplement: Placebo
1 inactive packet BID

Primary Outcome Measures :
  1. Intestinal Permeability - measured by Sugar Absorption Test [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Current diagnosis of small bowel or colonic Crohn's disease as defined by histological and 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 at least 2 months.
  • Procurement of written informed consent signed by the subject's legal guardian and study investigator(s) and patient assent.

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 and Infliximab.
  • Patients with diagnosis of other co-morbid diseases such as heart disease, renal disease, immunodeficiency, diabetes, or thyroid disease.
  • Patients with indwelling catheters.
  • Patients with short bowel syndrome
  • Positive urine pregnancy test for female subjects

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00944736

United States, Missouri
The Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
VSL Pharmaceuticals
Principal Investigator: Julia M Bracken, MD Children's Mercy Hospital

Responsible Party: Julia Bracken, Assistant Professor of Medicine, Children's Mercy Hospital Kansas City Identifier: NCT00944736     History of Changes
Other Study ID Numbers: 09 06-115
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: March 10, 2014
Last Verified: March 2014

Keywords provided by Julia Bracken, Children's Mercy Hospital Kansas City:
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases