Probiotics in the Treatment of Irritable Bowel Syndrome
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|ClinicalTrials.gov Identifier: NCT01837485|
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : April 23, 2013
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Drug: Lactol Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||March 2013|
The Symbiotic Lactol® (Bioplus Life Sciences Pvt.) was applied 3 times a day for 3 months. Lactol is composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.
|Placebo Comparator: Placebo||
Placebo pill was applied 3 times a day for 3 months
- Abdominal pain [ Time Frame: Up to 3 months ]Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.
- Constipation [ Time Frame: Up to 3 months ]Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.
- Diarrhea [ Time Frame: Up to 3 months ]Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.
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): NCT01837485
|Iran, Islamic Republic of|
|Isfahan, Iran, Islamic Republic of|
|Principal Investigator:||Mozhdeh Zahiri, MD||Islamic Azad University, Najafabad Branch|