Efficacy of Probiotic Bacteria in Subjects With IBS or Functional Diarrhea/ Bloating

July 8, 2013 updated by: University of North Carolina, Chapel Hill

Clinical Efficacy of Probiotic Bacteria in Subjects With Irritable Bowel Syndrome (IBS), Functional Diarrhea, or Functional Bloating

To determine if probiotics bacteria, specifically lactobacillus and bifidobacterium, improve gastrointestinal symptoms in patients with IBS, functional diarrhea, or functional bloating.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Functional Bowel disorders (FBD) including Irritable Bowel Syndrome (IBS) are characterized by a variable combination of chronic or recurrent gastrointestinal symptoms not explained by structural or biochemical abnormalities. IBS is the most common functional gastrointestinal disorder, affecting 8% to 23% of adults in the western world and accounts for 12% of primary care and 28% of gastroenterological practice visits yearly. The pathophysiology of IBS is not completely understood and currently available drug treatments for IBS are very limited (1-2). The apparent success of the use of probiotics in several gut disorders (e.g., IBD) together with the greater understanding of the role of inflammation and intestinal microflora in the pathophysiology of IBS has led to increased interest in use of probiotics in patients with IBS (3). The data on the use of probiotic in IBS is limited. However, few reported studies show encouraging results and suggests some symptomatic response and parallel improvement in quality of life (3-4). A controlled, double-blind study, randomized 20 patients with IBS to L. plantarum 299v or placebo for 4 weeks concluded that L. plantarum decreased abdominal pain and tended to normalize stool frequency in constipated patients (5). On the other hand, Lactobacillus casei GG, was found to improve stool consistency in patients with IBS and diarrhea (6). A recent randomized controlled trial using the probiotic formulation VSL#3 improved abdominal bloating in patients with diarrhea-predominant IBS. However, no differences in gastrointestinal transit measurement, bowel function scores or satisfactory global symptom relief were shown (7). The inconsistent findings of these clinical studies may be accounted to the differences in probiotics composition and the heterogeneous and multifactorial nature of the disorder. However, these studies indicate a potential relationship between probiotics therapy and functional abdominal symptoms and suggesting that the possible role of probiotics in the treatment of IBS deserves further study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject is 18 to 75 years old.
  • The subject is an ambulatory outpatient.
  • The subject has IBS, or functional diarrhea, or functional bloating according to the Rome II criteria for functional GI disorders.
  • The subject has the above symptoms for at least two weeks, despite current therapy. For diarrhea, we will use the definition of a mean of >2 bowel movements per day, or a mean score of > 4 on the Bristol Stool Form Scale per week. For bloating we will use the Rome II definition "a feeling of abdominal fullness or bloating".
  • Subject must have had a colonoscopy if age > 50y/o.
  • The subject's symptoms are mild to moderate symptoms in severity. Symptoms severity will be assessed at baseline and at the end of the 2-weeks screening period to determine eligibility prior randomization. Severity of bowel symptoms will be determined using the Francis Whorwell IBS severity scale: Mild <175, Moderate 175-300, Severe >300

Exclusion Criteria:

  • The subject has inflammation or structural abnormality of the digestive tract (e.g. inflammatory bowel disease (IBD), duodenal ulcer (DU) or gastric ulcer (GU), obstruction, symptomatic cholelithiasis).
  • The subject has severe FBD related symptoms at baseline.
  • The subject has a serious, unstable medical condition.
  • The subject has insulin-dependent Diabetes Mellitus.
  • The subject had a major psychiatric diagnosis or a suicide attempt within the last two years.
  • The subject has a history of alcohol or substance abuse within two years.
  • The subject has abnormal laboratory results (including ALT or AST > than 2.5 times normal, serum creatinine >2.0mg/dl, untreated abnormal TSH value)
  • The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer).
  • The subject has been diagnosed with lactase deficiency and this can explain their symptoms (i.e., symptoms resolved or reduced significantly with lactose-free diet.)
  • The subject has participated in a drug study within the last 21 days.
  • The subject received antibiotic treatment during the last 8 weeks. (If the subject was on antibiotic treatment, a washout period of 8 weeks is required).
  • The subject had previous significant intestinal surgery.
  • The subject is pregnant or lactating, or unwilling to maintain effective contraception during course of study
  • The subject is predisposed to infection (i.e. their immune system is compromised, they have rheumatic heart disease, an artificial valve, history of bacterial endocarditis, or an active bacterial disease)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: 2
Placebo
Dietary supplement: Placebo
Placebo administered bid for 6 weeks.
Experimental: 1
Probiotic containing Lactobacillus and Bifidobacterium
Dietary supplement: Probiotics - Lactobacillus and bifidobacterium
Probiotics administered bid for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
The primary outcome measure will be the global relief of GI symptoms as assessed by Global Symptom Assessment (GSA) of relief of functional GI symptoms.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Assess the improvement of specific functional bowel disorders (FBD) related symptoms and Health Related Quality of Life (HRQOL).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yehuda Ringel, MD, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 04-1704

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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