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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944736

Enrollment

Registered

2009-07-23

Start date

2009-07-31

Completion date

2013-07-31

Last updated

2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Keywords

Crohn's Disease, Pediatric, VSL#3, Permeability, Probiotic, Zonulin

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.

Interventions

DIETARY_SUPPLEMENTVSL#3

1 packet BID

DIETARY_SUPPLEMENTPlacebo

1 inactive packet BID

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame
Intestinal Permeability - measured by Sugar Absorption Test	3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026