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Completed

NCT Number: NCT01837940

Efficacy of a Dietary Supplementation With Lactobacillus Reuteri 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.

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Key information

Conditions

Constipation Abdominal Pain Deglutition Disorders Diarrhea Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Indigestion Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Reflux Signs and Symptoms Signs and Symptoms, Digestive

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Örebro University

Örebro, Närke, 701 82, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

Galactooligosaccharide (GOS) and rhamnose in a powder formulation

Lactobacillus reuteri DSM 17938

Dietary Supplement

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Other outcomes

  1. 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)

  2. 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.

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • BioGaia AB

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2013
Registry last updated
Dec 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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