Brief Summary

Skip to Participation Criteria

Official Title: "Metabolic Control of Type 2 Diabetes Patients Before and After Dietary Supplementation With the Probiotic Lactobacillus Reuteri DSM 17938 - a Pilot Study"

Recent data suggest that the trillions of bacteria in the investigators 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 and improved glucose tolerance. Administration of the probiotic bacterium Lactobacillus strain 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 studies to the investigators knowledge that address whether probiotic supplementation improves glucose metabolism in type 2 diabetes patients.

• Study Type: Interventional
• Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Study Primary Completion Date: December 2012

Interventions Used in this Clinical Trial

• Dietary Supplement: Lactobacillus reuteri DSM 17938
  • Ordinary treatment against type 2 diabetes is supplemented with one tablet containing 100 million Lactobacillus reuteri DSM 17398, once daily for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Other: Lactobacillus reuteri
  • Dietary supplementation with Lactobacillus reuteri DSM 17938

Outcome Measures for this Clinical Trial

Primary Measures

• HOMA index
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Changes in diabetes medication and hypoglycemia events
  • Time Frame: 12 weeks
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

• Type 2 diabetes with a duration > 6 months
• Abdominal obesity
• HbA1c 50-80 mmol/mol
• Written informed consent
• Stated availability throughout the study period

Exclusion Criteria

• Autoimmune diabetes eg type 1 diabetes
• Psychiatric illness or cancer diagnosis
• No foreseeable need of treatment with corticosteroids or antibiotics
• Inflammatory bowel disease
• Administration of antibiotics 4 weeks before inclusion
• Administration of probiotics 2 weeks before inclusion
• Participation in other clinical trials

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Vastra Gotaland Region
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Per-Anders E jansson, Adj prof, Principal Investigator, The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital S-413 45 Gothenburg, Sweden
  • Fredrik Bäckhed, Assoc prof, Study Chair, The Wallenberg Laboratory, Bruna Stråket 16, Sahlgrenska University Hospital, S-413 45 Gothenburg, Sweden
• Overall Contact(s)
  • Per-Anders E Jansson, Adj prof, 46 31 342 10 00, per-anders.jansson@medic.gu.se

References

Bäckhed F, Manchester JK, Semenkovich CF, Gordon JI. Mechanisms underlying the resistance to diet-induced obesity in germ-free mice. Proc Natl Acad Sci U S A. 2007 Jan 16;104(3):979-84. Epub 2007 Jan 8.