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

Irritable Bowel Syndrome Clinical Trial

— VSL#3  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00932841
• Other study ID #: 04-007
• Secondary ID: R21AT003400-01A2
• Status: Terminated
• Phase: Phase 1
• First received: July 2, 2009
• Last updated: March 16, 2012
• Start date: January 2008
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Dayton Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Placebo
One packet PO daily x 8 weeks.

Drug:
• VSL#3 900 billion bacteria
One packet PO daily, x 8 weeks
• VSL#3 90 billion bacteria
One packet PO daily, x 8 weeks.

Locations

Country	Name	City	State
United States	Children's Medical Center of Dayton	Dayton	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Dayton Children's Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (8)

APLEY J, NAISH N. Recurrent abdominal pains: a field survey of 1,000 school children. Arch Dis Child. 1958 Apr;33(168):165-70. — View 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. — View Citation

Bengmark S. Ecological control of the gastrointestinal tract. The role of probiotic flora. Gut. 1998 Jan;42(1):2-7. Review. — View Citation

Everhart JE, Renault PF. Irritable bowel syndrome in office-based practice in the United States. Gastroenterology. 1991 Apr;100(4):998-1005. — View 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. — View Citation

King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9. — View Citation

Nobaek S, Johansson ML, Molin G, Ahrné 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. — View Citation

Svedlund J, Sjödin 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Gastrointestinal Symptom Rating Scale		8 weeks	Yes
Secondary	Coddington life events questionnaire		8 weeks	No