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

Phase 3

Completed

• Conditions: Abdominal Pain; Constipation; Indigestion; Diarrhea; Reflux
• Interventions: Dietary Supplement: Lactobacillus reuteri DSM 17938; Dietary Supplement: Placebo

• Registration Number: NCT01837940
• Lead Sponsor: Örebro University, Sweden

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

Study Timeline

• Study First Submitted: 2013-03-26
• Study Start: 2013-04
• Study First Submitted QC: 2013-04-22
• Study First Posted: 2013-04-23
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-04
• Last Update Posted: 2014-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dietary supplement	Lactobacillus reuteri DSM 17938	Lactobacillus reuteri DSM 17938
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline Gastrointestinal symptoms to 3months	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 Outcome Measures

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

Trial Locations

Locations (1)

Örebro University; 🇸🇪 Örebro, Närke, Sweden