NCT01837485

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2013

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

1.4 years

First QC Date

April 18, 2013

Last Update Submit

April 18, 2013

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndromeFunctional gastrointestinal disordersGut floraProbiotics

Outcome Measures

Primary Outcomes (3)

  • Abdominal pain

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

    Up to 3 months

  • Constipation

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

    Up to 3 months

  • Diarrhea

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

    Up to 3 months

Study Arms (2)

Lactol

EXPERIMENTAL
Drug: Lactol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

LactolDRUG

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.

Lactol
PlaceboDRUG

Placebo pill was applied 3 times a day for 3 months

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shariati Hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Irritable Bowel SyndromeGastrointestinal Diseases

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesDigestive System Diseases

Study Officials

  • Mozhdeh Zahiri, MD

    Islamic Azad University, Najafabad Branch

    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

August 1, 2011

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations

IR(1)