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Completed

NCT Number: NCT01837472

Probiotics in the Treatment of Irritable Bowel Syndrome

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.

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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

Department of Gastroenterology, Alzahra Hospital

Isfahan, 81746-73461, 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

Probiotic

Drug

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

Drug

Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

Evaluating The Effects of Probiotics on Symptoms of Patients With Irritable Bowel Syndrome

Important dates

Study start
2012
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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