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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

July 2, 2009
March 16, 2012
January 2008
August 2011   (final data collection date for primary outcome measure)
The Gastrointestinal Symptom Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00932841 on ClinicalTrials.gov Archive Site
Coddington life events questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Use of VSL#3 in Irritable Bowel Syndrome in Children
The Use of VSL#3 in Irritable Bowel Syndrome in Children

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Irritable Bowel Syndrome
  • Other: Placebo
    One packet PO daily x 8 weeks.
    Other Name: VSL#3
  • Drug: VSL#3 900 billion bacteria
    One packet PO daily, x 8 weeks
    Other Name: VSL#3
  • Drug: VSL#3 90 billion bacteria
    One packet PO daily, x 8 weeks.
    Other Name: VSL#3
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Active Comparator: VSL#3 90 billion bacteria
    Intervention: Drug: VSL#3 90 billion bacteria
  • Active Comparator: VSL#3 900 billion bacteria
    Intervention: Drug: VSL#3 900 billion bacteria

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
13 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00932841
04-007, R21AT003400-01A2
Yes
Sonia Michail, MD, Children's Medical Center of Dayton
Dayton Children's Hospital
National Institutes of Health (NIH)
Principal Investigator: Sonia Michail, MD Wright State University, Children's Medical Center of Dayton
Dayton Children's Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP