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

NCT00944736 | Completed Phase 3 DMC

• 1 other identifier: 09 06-115
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Intestinal Permeability - measured by Sugar Absorption Test

  3 months

Study Arms (2)

VSL#3

ACTIVE COMPARATOR

Dietary Supplement: VSL#3

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

VSL#3 DIETARY_SUPPLEMENT

1 packet BID

VSL#3

Placebo DIETARY_SUPPLEMENT

1 inactive packet BID

Placebo

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• VSL Pharmaceuticals: collaborator

Study Sites (1)

The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Julia M Bracken, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

US (1)