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| Name | Class |
|---|---|
| BioGaia AB | INDUSTRY |
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| dietary supplement | Active Comparator | Lactobacillus reuteri DSM 17938 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Galactooligosaccharide (GOS) and rhamnose in a powder formulation |
| |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mood during the 3month intervention period | Mood changes will be assessed through the questionnaire hospital anxiety and depression scale (HADs) | at baseline, 2months and 3monts/study end |
| Change in quality of life during the 3-month intervention period |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Jan Brummer, MD, PhD | Örebro Universitet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University | Örebro | Närke | 701 82 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27612653 | Derived | 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. |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D003967 | Diarrhea |
| D004415 | Dyspepsia |
| D005764 | Gastroesophageal Reflux |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
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| Lactobacillus reuteri DSM 17938 |
| Dietary Supplement |
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation |
|
Quality of life will be assessed through the EuroQol questionnaire. |
| at baseline, at baseline, 2months and 3monts/study end |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |