Probiotics in the Treatment of Irritable Bowel Syndrome

NCT ID: NCT01837485

Last Updated: 2013-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Lactol

Group Type EXPERIMENTAL

Lactol

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill was applied 3 times a day for 3 months

Interventions

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Lactol

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.

Intervention Type DRUG

Placebo

Placebo pill was applied 3 times a day for 3 months

Intervention Type DRUG

Eligibility Criteria

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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

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Islamic Azad University, Najafabad Branch

OTHER

Sponsor Role lead

Responsible Party

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Mozhdeh Zahiri

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mozhdeh Zahiri, MD

Role: PRINCIPAL_INVESTIGATOR

Islamic Azad University, Najafabad Branch

Locations

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Shariati Hospital

Isfahan, Isfahan, Iran

Site Status

Countries

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Iran

Other Identifiers

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15010101882058

Identifier Type: -

Identifier Source: org_study_id

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