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

Örebro University, Sweden

Status and phase: Completed; Phase 3

Conditions: Diarrhea; Indigestion; Constipation; Abdominal Pain; Reflux

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Lactobacillus reuteri DSM 17938

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01837940

2012/309

Details and patient eligibility

About

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.

Full 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

Enrollment: 290 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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290 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo

dietary supplement

Active Comparator group

Description:

Lactobacillus reuteri DSM 17938

Treatment:

Dietary Supplement: Lactobacillus reuteri DSM 17938