Clinical trial NCT00932841: The Use of VSL#3 in Irritable Bowel Syndrome in Children
Official title: The Use of VSL#3 in Irritable Bowel Syndrome in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Irritable Bowel Syndrome
Lead sponsor: Dayton Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-07-03
Enrollment: 15
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: The Gastrointestinal Symptom Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Coddington life events questionnaire
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Dayton
country: United States
facility: Children's Medical Center of Dayton
state: Ohio
Study officials:
affiliation: Wright State University, Children's Medical Center of Dayton
name: Sonia Michail, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991 Apr;100(4):998-1005. doi: 10.1016/0016-5085(91)90275-p.
citation: Hamm LR, Sorrells SC, Harding JP, Northcutt AR, Heath AT, Kapke GF, Hunt CM, Mangel AW. Additional investigations fail to alter the diagnosis of irritable bowel syndrome in subjects fulfilling the Rome criteria. Am J Gastroenterol. 1999 May;94(5):1279-82. doi: 10.1111/j.1572-0241.1999.01077.x.
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citation: Bengmark S. Ecological control of the gastrointestinal tract. The role of probiotic flora. Gut. 1998 Jan;42(1):2-7. doi: 10.1136/gut.42.1.2. No abstract available.
citation: Nobaek S, Johansson ML, Molin G, Ahrne S, Jeppsson B. Alteration of intestinal microflora is associated with reduction in abdominal bloating and pain in patients with irritable bowel syndrome. Am J Gastroenterol. 2000 May;95(5):1231-8. doi: 10.1111/j.1572-0241.2000.02015.x.
citation: Svedlund J, Sjodin I, Dotevall G. GSRS--a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease. Dig Dis Sci. 1988 Feb;33(2):129-34. doi: 10.1007/BF01535722.
citation: Balsari A, Ceccarelli A, Dubini F, Fesce E, Poli G. The fecal microbial population in the irritable bowel syndrome. Microbiologica. 1982 Jul;5(3):185-94.