Probiotics in the Treatment of Irritable Bowel Syndrome

Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01837485

Enrollment

Registered

2013-04-23

Start date

2011-08-31

Completion date

2013-03-31

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

Some evidences have shown that probiotics are effective in the treatment of irritable bowel syndrome. Because few evidences are available in our population, we investigated if probiotics are effective in our patients as well. We hypothesize that the probiotic Lactol which contains Lactobacillus Sporogenes reduces the symptoms of irritable bowel syndrome.

Interventions

DRUGLactol

The Symbiotic Lactol® (Bioplus Life Sciences Pvt.) was applied 3 times a day for 3 months. Lactol is composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.

DRUGPlacebo

Placebo pill was applied 3 times a day for 3 months

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 3 months	Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.
Constipation	Up to 3 months	Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.
Diarrhea	Up to 3 months	Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.

Countries

Iran

Outcome results

None listed

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