Probiotics in the Treatment of Irritable Bowel Syndrome

NCT01837472 | Completed Phase 2

• 1 other identifier: 390506
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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

Keywords

Irritable bowel syndrome; Functional gastrointestinal disorders; Gut flora; Probiotics

Outcome Measures

Primary Outcomes (1)

• Abdominal pain

  Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks

  Up to 6 weeks

Secondary Outcomes (1)

• Quality of Life

  Up to 6 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Drug: Probiotic

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

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.

Probiotic

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65
• diagnosis of IBS based on the Rome III criteria
• willingness to participate

You may not qualify if:

• receiving other probiotics compound during the study
• receiving antibiotics during the study

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Department of Gastroenterology, Alzahra Hospital

Isfahan, Isfahan, 81746-73461, Iran

Location

Related 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.

  PMID: 19277023 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome; Gastrointestinal Diseases

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Somaye Farzamnia, MD

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 18, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

IR (1)