Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population

December 4, 2014 updated by: Robert Brummer, Örebro University, Sweden

Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population

The purpose of this study is to investigate the effect of a daily supplement consisting of the probiotic bacteria, Lactobacillus reuteri, on the digestive health among persons 65 years and older.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall purpose of the study is to investigate the effect of daily supplementation, during a three months period, of L. reuteri on digestive health in an elderly Swedish population, residing in the municipality of Örebro. In addition an extensive screening of the study population in regard of overall health status, functionality and well-being as well as the composition of the gut microbiome will be assessed prior study start through the collection of baseline data

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 3

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

  • Sweden
    • Närke
      • Örebro, Närke, Sweden, 701 82
        • Örebro University

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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 65 years
  • Informed consent signed by study participant or legal guardian

Exclusion Criteria:

  • Known gastrointestinal disease, with strictures, malignance's and ischemia.
  • Inflammatory bowel diseases (IBD)
  • Participation in other clinical trials in the past three months.

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
Galactooligosaccharide (GOS) and rhamnose in a powder formulation
Active Comparator: dietary supplement
Lactobacillus reuteri DSM 17938
Dietary supplement: Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Gastrointestinal symptoms to 3months
Time Frame: Baseline, at 2 months and at 3months/study end
Gastrointestinal discomfort will be assessed through the gastrointestinal symptoms rating score (GSRS), a clinical rating scale for gastrointestinal symptoms. The GSRS includes 15 symptoms and uses a 7-point Likert scale in which 1 represents the most positive option and 7 the most negative.
Baseline, at 2 months and at 3months/study end

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in use of intestinal motility regulating substances during the 3-month intervention period
Time Frame: at baseline and end of study ( 3months)
Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication)
at baseline and end of study ( 3months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in mood during the 3month intervention period
Time Frame: at baseline, 2months and 3monts/study end
Mood changes will be assessed through the questionnaire hospital anxiety and depression scale (HADs)
at baseline, 2months and 3monts/study end
Change in quality of life during the 3-month intervention period
Time Frame: at baseline, at baseline, 2months and 3monts/study end
Quality of life will be assessed through the EuroQol questionnaire.
at baseline, at baseline, 2months and 3monts/study end

Collaborators and Investigators

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

Sponsor

Örebro University, Sweden

Collaborators

BioGaia AB

Investigators

  • Principal Investigator: Robert Jan Brummer, MD, PhD, Örebro universitet

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

April 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

March 26, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimate)

April 23, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/309

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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