Probiotics in the Treatment of Irritable Bowel Syndrome

NCT ID: NCT01837472

Last Updated: 2013-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-04-30

Brief Summary

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.

Conditions

Irritable Bowel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: 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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Probiotic

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Ali Gholamrezaei

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Somaye Farzamnia, MD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences

Locations

Department of Gastroenterology, Alzahra Hospital

Isfahan, Isfahan, Iran

Countries

Iran

References

Brenner DM, Moeller MJ, Chey WD, Schoenfeld PS. The utility of probiotics in the treatment of irritable bowel syndrome: a systematic review. Am J Gastroenterol. 2009 Apr;104(4):1033-49; quiz 1050. doi: 10.1038/ajg.2009.25. Epub 2009 Mar 10.

Reference Type: BACKGROUND

PMID: 19277023 (View on PubMed)

Other Identifiers

390506

Identifier Type: -

Identifier Source: org_study_id