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

NCT00932841 | Terminated Phase 1 DMC

• 2 other identifiers: 04-007R21AT003400-01A2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• The Gastrointestinal Symptom Rating Scale

  8 weeks

Secondary Outcomes (1)

• Coddington life events questionnaire

  8 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Other: Placebo

VSL#3 90 billion bacteria

ACTIVE COMPARATOR

Drug: VSL#3 90 billion bacteria

VSL#3 900 billion bacteria

ACTIVE COMPARATOR

Drug: VSL#3 900 billion bacteria

Interventions

Placebo OTHER

One packet PO daily x 8 weeks.

Also known as: VSL#3

Placebo

VSL#3 900 billion bacteria DRUG

One packet PO daily, x 8 weeks

Also known as: VSL#3

VSL#3 900 billion bacteria

VSL#3 90 billion bacteria DRUG

One packet PO daily, x 8 weeks.

Also known as: VSL#3

VSL#3 90 billion bacteria

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dayton Children's Hospital: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Children's Medical Center of Dayton

Dayton, Ohio, 45404, United States

Location

Related 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. doi: 10.1136/adc.33.168.165. No abstract available.

  PMID: 13534750 BACKGROUND

• 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.

  PMID: 2001837 BACKGROUND

• 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.

  PMID: 10235207 BACKGROUND

• King TS, Elia M, Hunter JO. Abnormal colonic fermentation in irritable bowel syndrome. Lancet. 1998 Oct 10;352(9135):1187-9. doi: 10.1016/s0140-6736(98)02146-1.

  PMID: 9777836 BACKGROUND

• 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.

  PMID: 9505873 BACKGROUND

• 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.

  PMID: 10811333 BACKGROUND

• 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.

  PMID: 3123181 BACKGROUND

• 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.

  PMID: 7121297 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Sonia Michail, MD

  Wright State University, Children's Medical Center of Dayton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

US (1)