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Probiotics in the Treatment of Irritable Bowel Syndrome

Sponsor
Isfahan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01837472
Collaborator
(none)
132
Enrollment
1
Location
2
Arms
12
Duration (Months)
11
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluating The Effects of Probiotics on Symptoms of Patients With Irritable Bowel Syndrome
Study Start Date :
Apr 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Apr 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Probiotic

Drug: Probiotic
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.
Placebo Comparator: Placebo

Drug: Placebo
Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.

Outcome Measures

Primary Outcome Measures

  1. Abdominal pain [Up to 6 weeks]

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

Secondary Outcome Measures

  1. Quality of Life [Up to 6 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Gastroenterology, Alzahra Hospital Isfahan Iran, Islamic Republic of 81746-73461

Sponsors and Collaborators

  • Isfahan University of Medical Sciences

Investigators

  • Principal Investigator: Somaye Farzamnia, MD, Isfahan University of Medical Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Gholamrezaei, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01837472
Other Study ID Numbers:
  • 390506
First Posted:
Apr 23, 2013
Last Update Posted:
Apr 23, 2013
Last Verified:
Apr 1, 2013
Keywords provided by Ali Gholamrezaei, Dr., Isfahan University of Medical Sciences
Irritable bowel syndrome
Functional gastrointestinal disorders
Gut flora
Probiotics
Additional relevant MeSH terms:
Irritable Bowel Syndrome
Syndrome

Study Results

No Results Posted as of Apr 23, 2013