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Probiotics in the Treatment of Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT01837472
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
Sponsor:
Information provided by (Responsible Party):
Ali Gholamrezaei, Isfahan University of Medical Sciences

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
Irritable Bowel Syndrome Drug: Probiotic Drug: Placebo Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
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 : April 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

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.




Primary Outcome Measures :
  1. Abdominal pain [ Time Frame: 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 [ Time Frame: Up to 6 weeks ]
    Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837472


Locations
Iran, Islamic Republic of
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

Publications:
Responsible Party: Ali Gholamrezaei, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01837472     History of Changes
Other Study ID Numbers: 390506
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Ali Gholamrezaei, Isfahan University of Medical Sciences:
Irritable bowel syndrome
Functional gastrointestinal disorders
Gut flora
Probiotics

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases