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Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)
Sponsor: Universidad Católica San Antonio de Murcia
Summary
This randomized, double-blind clinical trial aims to evaluate the effect of a probiotic supplement on gut microbiota composition and glycemic control in adults with type 1 diabetes mellitus. A secondary comparison will be made with a healthy control group. Participants will be assigned to receive either a probiotic or a placebo for 98 days. Stool samples and metabolic parameters will be collected at baseline and after the intervention period. The study seeks to better understand how modulation of the intestinal microbiota may influence glucose regulation in people with type 1 diabetes.
Official title: Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-09
Completion Date
2025-12
Last Updated
2025-07-14
Healthy Volunteers
Yes
Conditions
Interventions
Probiotic/Prebiotic Supplement
Oral dietary supplement in gel form (10 mL per day) containing 4000 mg of inulin and 1000 mg of tyndallized probiotics. Administered once daily for approximately 98 consecutive days. Produced by Martínez Nieto S.A. (MARNYS®). Intended to modulate gut microbiota and improve glycemic and inflammatory markers.
Placebo Gel
Oral placebo in gel form (10 mL per day), identical in appearance, texture, and taste to the active supplement, but without probiotic or prebiotic components. Administered once daily for 98 days to maintain blinding and control effects.
Locations (1)
UCAM San Antonio Catholic University of Murcia
Murcia, Murcia, Spain