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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
Sponsor:
Information provided by (Responsible Party):
Mozhdeh Zahiri, Islamic Azad University, Najafabad Branch

Brief Summary:
Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Lactol Drug: Lactol
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 Drug: Placebo
Placebo pill was applied 3 times a day for 3 months




Primary Outcome Measures :
  1. Abdominal pain [ Time Frame: Up to 3 months ]
    Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.

  2. Constipation [ Time Frame: Up to 3 months ]
    Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.

  3. Diarrhea [ Time Frame: Up to 3 months ]
    Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.



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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): NCT01837485


Locations
Iran, Islamic Republic of
Shariati Hospital
Isfahan, Iran, Islamic Republic of
Sponsors and Collaborators
Islamic Azad University, Najafabad Branch
Investigators
Principal Investigator: Mozhdeh Zahiri, MD Islamic Azad University, Najafabad Branch

Responsible Party: Mozhdeh Zahiri, Dr., Islamic Azad University, Najafabad Branch
ClinicalTrials.gov Identifier: NCT01837485     History of Changes
Other Study ID Numbers: 15010101882058
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: April 23, 2013
Last Verified: April 2013

Keywords provided by Mozhdeh Zahiri, Islamic Azad University, Najafabad Branch:
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