The Use of VSL#3 in Irritable Bowel Syndrome in Children

This study has been terminated.
(PI has re-located. PI terminated FDA IND # and closed study.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sonia Michail, MD, Children's Medical Center of Dayton
ClinicalTrials.gov Identifier:
NCT00932841
First received: July 2, 2009
Last updated: March 16, 2012
Last verified: March 2012
  Purpose

The goal of this study is to determine whether the oral administration of the probiotic VSL#3 under randomized, placebo-controlled conditions will improve symptoms of irritable bowel syndrome in children, safely.


Condition Intervention Phase
Irritable Bowel Syndrome
Other: Placebo
Drug: VSL#3 900 billion bacteria
Drug: VSL#3 90 billion bacteria
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Use of VSL#3 in Irritable Bowel Syndrome in Children

Further study details as provided by Dayton Children's Hospital:

Primary Outcome Measures:
  • The Gastrointestinal Symptom Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Coddington life events questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: January 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
One packet PO daily x 8 weeks.
Other Name: VSL#3
Active Comparator: VSL#3 90 billion bacteria Drug: VSL#3 90 billion bacteria
One packet PO daily, x 8 weeks.
Other Name: VSL#3
Active Comparator: VSL#3 900 billion bacteria Drug: VSL#3 900 billion bacteria
One packet PO daily, x 8 weeks
Other Name: VSL#3

Detailed Description:

Determine the safety and efficacy of different doses of VSL#3 in the treatment of children with irritable bowel syndrome: Children will be recruited from the pediatric gastroenterology clinic at The Children's Medical Center in Dayton, Ohio. Eighty four children will be enrolled in this controlled, double-blinded, randomized study. All children will have had a prior evaluation by a pediatric gastroenterologist who has diagnosed these patients with irritable bowel syndrome and excluded organic disease as a cause of the child's abdominal pain.

  Eligibility

Ages Eligible for Study:   13 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All children should fulfill Rome ll criteria for IBS.
  • Organic disease has been excluded.
  • Age 13-18 years.
  • Have active symptoms for at least 2 weeks prior to randomization. A minimum of 4.0 on the 7-point Likert scale for the two weeks prior to randomization on the GSRS-IBS composite pain score will be required.
  • Diarrhea predominant IBS: Diarrhea is defined as increased stool frequency more than 3 times daily or change in form to loose or watery stools.

Exclusion Criteria:

  • Children not fulfilling the inclusion criteria.
  • Children receiving medication for the treatment of irritable bowel syndrome within 2 weeks of randomization.
  • Children receiving antibiotic therapy or other probiotic agents within 4 weeks of randomization.
  • Children receiving other medication known to cause abdominal pain.
  • Children diagnosed with any of the following GI disorders: IBD (Crohn's disease or UC), Celiac disease, Gastroparesis, abdominal adhesions, Gastrointestinal perforation, Gastrointestinal obstruction and/or stricture, chronic or recurrent pancreatitis.
  • Children who had undergone previous abdominal surgery (with the exception of uncomplicated appendectomy or cholecystectomy greater than or equal to 6 months prior to enrollment).
  • Children with a history of any disease that may affect bowel motility such as diabetes mellitus, or poorly controlled hypo/hyperthyroidism.
  • Children with immune deficiency, on immune-suppressants, or have active psychiatric, neurological, metabolic, renal, hepatic, infectious, hematological, cardiovascular or pulmonary disease.
  • Children with a history of malignancy.
  • Pregnancy.
  • Children with history of allergy to maize or probiotics.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932841

Locations
United States, Ohio
Children's Medical Center of Dayton
Dayton, Ohio, United States, 45404
Sponsors and Collaborators
Dayton Children's Hospital
Investigators
Principal Investigator: Sonia Michail, MD Wright State University, Children's Medical Center of Dayton
  More Information

Publications:
Responsible Party: Sonia Michail, MD, Principal Investigator, Children's Medical Center of Dayton
ClinicalTrials.gov Identifier: NCT00932841     History of Changes
Other Study ID Numbers: 04-007, R21AT003400-01A2
Study First Received: July 2, 2009
Last Updated: March 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014