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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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||
Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.
- Abdominal pain [ Time Frame: Up to 6 weeks ]Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks
- 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.
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
|Iran, Islamic Republic of|
|Department of Gastroenterology, Alzahra Hospital|
|Isfahan, Iran, Islamic Republic of, 81746-73461|
|Principal Investigator:||Somaye Farzamnia, MD||Isfahan University of Medical Sciences|