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Probiotics in the Treatment of Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lactol
Placebo
Sponsored by
Islamic Azad University, Najafabad Branch
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome, Functional gastrointestinal disorders, Gut flora, Probiotics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shariati Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2013
Last Updated
April 18, 2013
Sponsor
Islamic Azad University, Najafabad Branch
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1. Study Identification

Unique Protocol Identification Number
NCT01837485
Brief Title
Probiotics in the Treatment of Irritable Bowel Syndrome
Official Title
Evaluation of the Effects of Lactol Probiotic in Comparison With Placebo on Symptoms of Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Najafabad Branch

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome, Functional gastrointestinal disorders, Gut flora, Probiotics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lactol
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo pill was applied 3 times a day for 3 months
Primary Outcome Measure Information:
Title
Abdominal pain
Description
Abdominal pain was assessed by Rome III questionnaire at baseline and then after 3 months.
Time Frame
Up to 3 months
Title
Constipation
Description
Constipation was assessed by Rome III questionnaire at baseline and then after 3 months.
Time Frame
Up to 3 months
Title
Diarrhea
Description
Diarrhea was assessed by Rome III questionnaire at baseline and then after 3 months.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mozhdeh Zahiri, MD
Organizational Affiliation
Islamic Azad University, Najafabad Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shariati Hospital
City
Isfahan
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Probiotics in the Treatment of Irritable Bowel Syndrome

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