Metabolic Control Before and After Supplementation With Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes Patients

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01620125

Enrollment

Registered

2012-06-15

Start date

2012-05-31

Completion date

2012-12-31

Last updated

2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes, Insulin Resistance

Keywords

Lactobacillus, Gut microbiota, Diabetes mellitus

Brief summary

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.

Interventions

DIETARY_SUPPLEMENTLactobacillus 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
HOMA index	12 weeks	To determine improved glucose handling and insulin sensitivity in adult type 2 diabetic patients supplemented with the probiotic L. reuteri DSM 17938 over a 12 week period, we assess insulin sensitivity via the HOMA index (fp-Glucose x fS-Insulin divided by 22.5).

Secondary

Measure	Time frame	Description
Changes in diabetes medication and hypoglycemia events	12 weeks	We monitor changes in diabetes medication and hypoglycemia events. Dosages of medication with oral hypoglycemic agents and number of insulin units per 24 hrs and number of hypoglycemia events will be registered in diaries.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026