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Probiotics in the Treatment of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Functional gastrointestinal disorders, Gut flora, Probiotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age between 18 and 65
  • diagnosis of IBS based on the Rome III criteria
  • willingness to participate

Exclusion Criteria:

  • receiving other probiotics compound during the study
  • receiving antibiotics during the study

Sites / Locations

  • Department of Gastroenterology, Alzahra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Abdominal pain
Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks

Secondary Outcome Measures

Quality of Life
Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.

Full Information

First Posted
April 18, 2013
Last Updated
April 22, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01837472
Brief Title
Probiotics in the Treatment of Irritable Bowel Syndrome
Official Title
Evaluating The Effects of Probiotics on Symptoms of Patients With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Evidence have shown benefits of gut flora modulation in treatment of irritable bowel syndrome (IBS), but few reports are available on the effects of multistrain probiotics and there are few reports available in this regard from our society. Thus, we investigated if probiotics are effective in our patients as well. We hypothesize that the multistrain probiotic Balance containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains, and Streptococcus thermophiles reduces the symptoms of irritable bowel syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, Functional gastrointestinal disorders, Gut flora, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Probiotic
Intervention Description
Patients in the probiotic group received the probiotic compound Balance® (Protexin Co., Somerset, UK) or similar placebo, twice daily after meal for 14 consecutive days. Balance® capsules contains seven bacteria species including Lactobacillus strains (L. casei, L. rhamnosus, L. acidophilus, and L. bulgaricus), Bifidobacterium strains (B. breve and B. longum), and Streptococcus thermophiles. Total viable count (TVC) is 1 x 108 CFU/per capsule. Other Ingredients are Fructo-oligosaccharide as prebiotic, magnesium stearate, and hydroxypropyl methyl cellulose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.
Primary Outcome Measure Information:
Title
Abdominal pain
Description
Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks
Time Frame
Up to 6 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.
Time Frame
Up to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 18 and 65 diagnosis of IBS based on the Rome III criteria willingness to participate Exclusion Criteria: receiving other probiotics compound during the study receiving antibiotics during the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Somaye Farzamnia, MD
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, Alzahra Hospital
City
Isfahan
ZIP/Postal Code
81746-73461
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19277023
Citation
Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS. The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol. 2009 Apr;104(4):1033-49; quiz 1050. doi: 10.1038/ajg.2009.25. Epub 2009 Mar 10.
Results Reference
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Probiotics in the Treatment of Irritable Bowel Syndrome

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