Constipation, Diarrhea, Indigestion, Reflux, Abdominal Pain
Conditions
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
Interventions
DIETARY_SUPPLEMENTPlacebo
Galactooligosaccharide (GOS) and rhamnose in a powder formulation
DIETARY_SUPPLEMENTLactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation
Sponsors
BioGaia AB
Örebro University, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in mood during the 3month intervention period | at baseline, 2months and 3monts/study end | Mood changes will be assessed through the questionnaire hospital anxiety and depression scale (HADs) |
| Change in quality of life during the 3-month intervention period | at baseline, at baseline, 2months and 3monts/study end | Quality of life will be assessed through the EuroQol questionnaire. |
Countries
Sweden
Outcome results
None listed