Probiotics in the Treatment of Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837472
• Other study ID #: 390506
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 18, 2013
• Last updated: April 22, 2013
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2013
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Gastroenterology, Alzahra Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal pain	Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks	Up to 6 weeks	No
Secondary	Quality of Life	Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.	Up to 6 weeks	No