Probiotics in the Treatment of Irritable Bowel Syndrome

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837472

Enrollment

132

Registered

2013-04-23

Start date

2012-04-30

Completion date

2013-04-30

Last updated

2013-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

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

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.

Interventions

DRUGProbiotic

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.

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Abdominal pain	Up to 6 weeks	Abdominal pain was assessed by Rome III questionnaire at baseline and then after 6 weeks

Secondary

Measure	Time frame	Description
Quality of Life	Up to 6 weeks	Quality of life was assessed by the IBS-QOL questionnaire at baseline and then after 6 weeks.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026