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

NCT ID: NCT01837940

Last Updated: 2014-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-09-30

Brief Summary

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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

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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

Conditions

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Constipation Diarrhea Indigestion Reflux Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Galactooligosaccharide (GOS) and rhamnose in a powder formulation

dietary supplement

Lactobacillus reuteri DSM 17938

Group Type ACTIVE_COMPARATOR

Lactobacillus reuteri DSM 17938

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation

Interventions

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Placebo

Galactooligosaccharide (GOS) and rhamnose in a powder formulation

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM 17938

Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BioGaia AB

INDUSTRY

Sponsor Role collaborator

Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Robert Brummer

Professor and Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Jan Brummer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro Universitet

Locations

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Örebro University

Örebro, Närke, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 27612653 (View on PubMed)

Other Identifiers

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2012/309

Identifier Type: -

Identifier Source: org_study_id