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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
VSL#3
Placebo
Sponsored by
Children's Mercy Hospital Kansas City
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn's Disease, Pediatric, VSL#3, Permeability, Probiotic, Zonulin

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Mercy Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

VSL#3

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Intestinal Permeability - measured by Sugar Absorption Test

Secondary Outcome Measures

Full Information

First Posted
July 22, 2009
Last Updated
March 6, 2014
Sponsor
Children's Mercy Hospital Kansas City
Collaborators
VSL Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00944736
Brief Title
Effect of VSL#3 on Intestinal Permeability in Pediatric Crohn's Disease
Official Title
Effect of Probiotic VSL#3 on Intestinal Permeability of Pediatric Patients With Crohn's Disease in Remission
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Mercy Hospital Kansas City
Collaborators
VSL Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
Crohn's Disease, Pediatric, VSL#3, Permeability, Probiotic, Zonulin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VSL#3
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
VSL#3
Intervention Description
1 packet BID
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
1 inactive packet BID
Primary Outcome Measure Information:
Title
Intestinal Permeability - measured by Sugar Absorption Test
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia M Bracken, MD
Organizational Affiliation
Children's Mercy Hospital Kansas City
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

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

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