Metabolic Effects of Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes

NCT01836796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2013-10-25

No results posted yet for this study

Summary

Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an altered gut microbiota and germ-free mice are resistant to developing diet-induced obesity and have lower fasting insulin and glucose concentrations and shows an improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus Gasseri SBT2055 in fermented milk for 12 weeks reduced adiposity and body weight in obese adults possibly by reducing lipid absorption and inflammatory status. However, there are no controlled studies to the investigators knowledge that address whether probiotic supplementation affects glucose metabolism. The investigators hypothesis is that supplementation of Lactobacillus reuteri DSM 17938 may improve metabolic control in type 2 diabetes patients. In addition, the investigators will explore possible mechanisms behind the antihyperglycemic action of Lactobacillus Reuteri.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lactobacillus Reuteri

100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.

DIETARY_SUPPLEMENT

Lactobacillus Reuteri DSM17938

Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.

Sponsors & Collaborators

  • BioGaia AB

    collaborator INDUSTRY
  • Vastra Gotaland Region

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-04-30
Completion
2013-07-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01836796 on ClinicalTrials.gov