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

NCT01837940 | Completed Phase 3

• 1 other identifier: 2012/309
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation; Diarrhea; Indigestion; Reflux; Abdominal Pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in use of intestinal motility regulating substances during the 3-month intervention period

  at baseline and end of study ( 3months)

Other Outcomes (2)

• Change in mood during the 3month intervention period

  at baseline, 2months and 3monts/study end

• Change in quality of life during the 3-month intervention period

  at baseline, at baseline, 2months and 3monts/study end

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

dietary supplement

ACTIVE COMPARATOR

Lactobacillus reuteri DSM 17938

Dietary Supplement: Lactobacillus reuteri DSM 17938

Interventions

Placebo DIETARY_SUPPLEMENT

Galactooligosaccharide (GOS) and rhamnose in a powder formulation

Placebo

Lactobacillus reuteri DSM 17938 DIETARY_SUPPLEMENT

Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation

dietary supplement

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥ 65 years
• Informed consent signed by study participant or legal guardian

You may not qualify if:

• Known gastrointestinal disease, with strictures, malignance's and ischemia.
• Inflammatory bowel diseases (IBD)
• Participation in other clinical trials in the past three months.

Sponsors & Collaborators

• Örebro University, Sweden: lead
• BioGaia AB: collaborator

Study Sites (1)

Örebro University

Örebro, Närke, 701 82, Sweden

Location

Related Publications (1)

• 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.

  PMID: 27612653 DERIVED

MeSH Terms

Conditions

Constipation; Diarrhea; Dyspepsia; Gastroesophageal Reflux; Abdominal Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations

Study Officials

• Robert Jan Brummer, MD, PhD

  Örebro Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: April 23, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

SE (1)