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

Primary Purpose

Constipation, Diarrhea, Indigestion

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Placebo
Lactobacillus reuteri DSM 17938
Sponsored by
Örebro University, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Örebro University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

dietary supplement

Arm Description

Lactobacillus reuteri DSM 17938

Outcomes

Primary Outcome Measures

Change from baseline Gastrointestinal symptoms to 3months
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.

Secondary Outcome Measures

Change in use of intestinal motility regulating substances during the 3-month intervention period
Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication)

Full Information

First Posted
March 26, 2013
Last Updated
December 4, 2014
Sponsor
Örebro University, Sweden
Collaborators
BioGaia AB
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1. Study Identification

Unique Protocol Identification Number
NCT01837940
Brief Title
Efficacy of a Dietary Supplementation With Lactobacillus Reuteri for Digestive Health in an Elderly Population
Official Title
Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro University, Sweden
Collaborators
BioGaia AB

4. Oversight

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Diarrhea, Indigestion, Reflux, Abdominal Pain

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
dietary supplement
Arm Type
Active Comparator
Arm Description
Lactobacillus reuteri DSM 17938
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Galactooligosaccharide (GOS) and rhamnose in a powder formulation
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri DSM 17938
Intervention Description
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation
Primary Outcome Measure Information:
Title
Change from baseline Gastrointestinal symptoms to 3months
Description
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.
Time Frame
Baseline, at 2 months and at 3months/study end
Secondary Outcome Measure Information:
Title
Change in use of intestinal motility regulating substances during the 3-month intervention period
Description
Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication)
Time Frame
at baseline and end of study ( 3months)
Other Pre-specified Outcome Measures:
Title
Change in mood during the 3month intervention period
Description
Mood changes will be assessed through the questionnaire hospital anxiety and depression scale (HADs)
Time Frame
at baseline, 2months and 3monts/study end
Title
Change in quality of life during the 3-month intervention period
Description
Quality of life will be assessed through the EuroQol questionnaire.
Time Frame
at baseline, at baseline, 2months and 3monts/study end

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Jan Brummer, MD, PhD
Organizational Affiliation
Örebro Universitet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Örebro University
City
Örebro
State/Province
Närke
ZIP/Postal Code
701 82
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
27612653
Citation
Ostlund-Lagerstrom L, Kihlgren A, Repsilber D, Bjorksten B, Brummer RJ, Schoultz I. Probiotic administration among free-living older adults: a double blinded, randomized, placebo-controlled clinical trial. Nutr J. 2016 Sep 10;15(1):80. doi: 10.1186/s12937-016-0198-1.
Results Reference
derived

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

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