Constipation Clinical Trial
Official title:
Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 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.
Status | Completed |
Enrollment | 290 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Örebro University | Örebro | Närke |
Lead Sponsor | Collaborator |
---|---|
Örebro University, Sweden | BioGaia AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | No |
Other | Change in quality of life during the 3-month intervention period | Quality of life will be assessed through the EuroQol questionnaire. | at baseline, at baseline, 2months and 3monts/study end | No |
Primary | 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 | No |
Secondary | 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) | No |
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