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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

One packet PO daily x 8 weeks.

VSL#3 90 billion bacteria

Group Type ACTIVE_COMPARATOR

VSL#3 90 billion bacteria

Intervention Type DRUG

One packet PO daily, x 8 weeks.

VSL#3 900 billion bacteria

Group Type ACTIVE_COMPARATOR

VSL#3 900 billion bacteria

Intervention Type DRUG

One packet PO daily, x 8 weeks

Interventions

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Placebo

One packet PO daily x 8 weeks.

Intervention Type OTHER

VSL#3 900 billion bacteria

One packet PO daily, x 8 weeks

Intervention Type DRUG

VSL#3 90 billion bacteria

One packet PO daily, x 8 weeks.

Intervention Type DRUG

Other Intervention Names

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VSL#3 VSL#3 VSL#3

Eligibility Criteria

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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.

* 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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No