Back to resultsThe Use of VSL#3 in Irritable Bowel Syndrome in Children (VSL#3)
Primary Purpose
Irritable Bowel Syndrome
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo
VSL#3 900 billion bacteria
VSL#3 90 billion bacteria
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
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.
Sites / Locations
- Children's Medical Center of Dayton
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
VSL#3 90 billion bacteria
VSL#3 900 billion bacteria
Arm Description
Outcomes
Primary Outcome Measures
The Gastrointestinal Symptom Rating Scale
Secondary Outcome Measures
Coddington life events questionnaire
Full Information
NCT ID
NCT00932841
First Posted
July 2, 2009
Last Updated
March 16, 2012
Sponsor
Dayton Children's Hospital
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00932841
Brief Title
The Use of VSL#3 in Irritable Bowel Syndrome in Children
Acronym
VSL#3
Official Title
The Use of VSL#3 in Irritable Bowel Syndrome in Children
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
PI has re-located. PI terminated FDA IND # and closed study.
Study Start Date
January 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dayton Children's Hospital
Collaborators
National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
VSL#3 90 billion bacteria
Arm Type
Active Comparator
Arm Title
VSL#3 900 billion bacteria
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
VSL#3
Intervention Description
One packet PO daily x 8 weeks.
Intervention Type
Drug
Intervention Name(s)
VSL#3 900 billion bacteria
Other Intervention Name(s)
VSL#3
Intervention Description
One packet PO daily, x 8 weeks
Intervention Type
Drug
Intervention Name(s)
VSL#3 90 billion bacteria
Other Intervention Name(s)
VSL#3
Intervention Description
One packet PO daily, x 8 weeks.
Primary Outcome Measure Information:
Title
The Gastrointestinal Symptom Rating Scale
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Coddington life events questionnaire
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonia Michail, MD
Organizational Affiliation
Wright State University, Children's Medical Center of Dayton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Medical Center of Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
13534750
Citation
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.
Results Reference
background
PubMed Identifier
2001837
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.
Results Reference
background
PubMed Identifier
10235207
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.
Results Reference
background
PubMed Identifier
9777836
Citation
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.
Results Reference
background
PubMed Identifier
9505873
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.
Results Reference
background
PubMed Identifier
10811333
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.
Results Reference
background
PubMed Identifier
3123181
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.
Results Reference
background
PubMed Identifier
7121297
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.
Results Reference
background
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The Use of VSL#3 in Irritable Bowel Syndrome in Children
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