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

Study Overview
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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

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

Conditions
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Constipation, Diarrhea, Indigestion, Reflux, Abdominal Pain

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Lactobacillus reuteri DSM 17938


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication) | at baseline and end of study ( 3months) |