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

Crohn's Disease Clinical Trial

Official title:

Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944736
• Other study ID #: 09 06-115
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2009
• Last updated: March 6, 2014
• Start date: July 2009
• Est. completion date: July 2013

Study information

• Verified date: March 2014
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Dietary Supplement:
• VSL#3
1 packet BID
• Placebo
1 inactive packet BID

Locations

Country	Name	City	State
United States	The Children's Mercy Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City	VSL Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intestinal Permeability - measured by Sugar Absorption Test		3 months	No