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Completed

NCT Number: NCT01837485

Probiotics in the Treatment of Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shariati Hospital

Isfahan, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactol

Drug

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

Drug

Placebo pill was applied 3 times a day for 3 months

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Islamic Azad University, Najafabad Branch

Other

Registry information

Official study title

Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Apr 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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