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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01837940
Other study ID # 2012/309
Secondary ID
Status Completed
Phase Phase 3
First received March 26, 2013
Last updated December 4, 2014
Start date April 2013
Est. completion date September 2013

Study information

Verified date December 2014
Source Örebro University, Sweden
Contact n/a
Is FDA regulated No
Health authority Sweden: The ethical review board; Regionala etikprövningsnämnden i Uppsala
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo
Galactooligosaccharide (GOS) and rhamnose in a powder formulation
Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation

Locations

Country Name City State
Sweden Örebro University Örebro Närke

Sponsors (2)

Lead Sponsor Collaborator
Örebro University, Sweden BioGaia AB

Country where clinical trial is conducted

Sweden, 

Outcome

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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