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

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ClinicalTrials.gov Identifier: NCT01837940
Recruitment Status : Completed
First Posted : April 23, 2013
Last Update Posted : December 5, 2014
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Robert Brummer, Örebro University, Sweden

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.

Condition or disease Intervention/treatment Phase
Constipation Diarrhea Indigestion Reflux Abdominal Pain Dietary Supplement: Placebo Dietary Supplement: Lactobacillus reuteri DSM 17938 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population
Study Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Dietary Supplement: Placebo
Galactooligosaccharide (GOS) and rhamnose in a powder formulation

Active Comparator: dietary supplement
Lactobacillus reuteri DSM 17938
Dietary Supplement: Lactobacillus reuteri DSM 17938
Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation




Primary Outcome Measures :
  1. Change from baseline Gastrointestinal symptoms to 3months [ Time Frame: 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 Outcome Measures :
  1. Change in use of intestinal motility regulating substances during the 3-month intervention period [ Time Frame: at baseline and end of study ( 3months) ]
    Intestinal motility regulating substances (e.g anti-diarrheal and anti-constipation medication)


Other Outcome Measures:
  1. Change in mood during the 3month intervention period [ Time Frame: at baseline, 2months and 3monts/study end ]
    Mood changes will be assessed through the questionnaire hospital anxiety and depression scale (HADs)

  2. Change in quality of life during the 3-month intervention period [ Time Frame: at baseline, at baseline, 2months and 3monts/study end ]
    Quality of life will be assessed through the EuroQol questionnaire.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01837940


Locations
Sweden
Örebro University
Örebro, Närke, Sweden, 701 82
Sponsors and Collaborators
Örebro University, Sweden
BioGaia AB
Investigators
Principal Investigator: Robert Jan Brummer, MD, PhD Örebro Universitet

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert Brummer, Professor and Dean, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT01837940     History of Changes
Other Study ID Numbers: 2012/309
First Posted: April 23, 2013    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Constipation
Diarrhea
Abdominal Pain
Dyspepsia
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases