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

Constipation Clinical Trial

Official title:

Efficacy of a Dietary Supplementation With Lactobacillus Reuteri DSM 17938 for Digestive Health in an Elderly Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01837940
• Other study ID #: 2012/309
• 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

• Abdominal Pain
• Constipation
• Diarrhea
• Indigestion
• Reflux

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