Status:
UNKNOWN
Effect of Probiotic Supplementation on Fecal Microbiota, Nutritional Status, Metabolic and Inflammatory Parameters in Patients With Type 2 Diabetes Mellitus
Lead Sponsor:
Universidade Federal de Santa Catarina
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
35-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effect of probiotic supplementation on fecal microbiota, nutritional status, metabolic and inflammatory parameters in patients with type 2 diabetes mellitu...
Detailed Description
The purpose of this study is to evaluate the effect of multispecies probiotic supplementation (specifically designed for the present study) on fecal microbiota, nutritional status, metabolic and infla...
Eligibility Criteria
Inclusion
- Age from 35 to 75 years old;
- Individuals diagnosed with type 2 diabetes mellitus (at least 1 year ago);
- Body mass index from 25.00 kg/m² to 39.99 kg/m²;
- Glycated hemoglobin ≤ 9.0% ;
- Using metformin, combined or not with other antidiabetic drugs
Exclusion
- Previous bowel diseases (inflammatory bowel disease and irritable bowel syndrome); or previous gastrointestinal surgery (eg, colectomy, gastrectomy)
- Intolerances and ∕ or food allergies with a previous medical diagnosis (eg lactose intolerance or celiac disease);
- Glomerular filtration rate \<30 ml/min/1.73m²; inflammatory diseases and immunodeficiencies;
- Diagnosis of autonomic neuropathy with gastrointestinal involvement such as: diabetic gastroparesis, diabetic enteropathy (diarrhea) or colonic hypomotility (constipation);
- Hospital admission and/or use of anti-inflammatory drugs (non-hormonal and corticosteroids) up to 1 month before the study; and ∕or use of antibiotics up to 3 months before the study;
- Regular use of laxatives, opioid narcotic analgesics or appetite suppressants;
- Current or previous use (up to 1 month) of prebiotics, probiotics, symbiotics or products enriched with these food supplements;
- Intolerance to prebiotics, probiotics or symbiotics;
- Pregnant or breastfeeding;
- Follow-up of a diet, guided by a nutritionist, for weight loss or gain up to 1 month before the study or current follow-up of unusual diets (eg vegetarian, macrobiotic, paleolithic);
- Alcohol consumption (\> 1 drink/day or 14g of alcohol for women; \>2 drinks/day or 28 grams of alcohol for men); use of illicit drugs and smokers;
- Change of lipid-lowering and/or antidiabetic drugs in the last 3 months
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 24 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05418179
Start Date
December 1 2021
End Date
December 24 2023
Last Update
March 28 2023
Active Locations (1)
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1
Polydoro Ernani de São Thiago University Hospital
Florianópolis, Santa Catarina, Brazil, 88036-800