Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad Católica San Antonio de Murcia

About this trial

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.

Eligibility criteria

Qualifiers

Age between 18 and 65 years.

Ability to understand and sign the informed consent form.

For the patient group: diagnosis of type 1 diabetes with at least 1 year of disease progression.

For the control group: healthy individuals without a diagnosis of diabetes or other metabolic disorders.

Disqualifiers

Current use of probiotics, prebiotics, or antibiotics.

Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).

Pregnancy or breastfeeding.

Participation in another clinical trial within the past 3 months.

Trial design

Treatments tested in this trial

  • Probiotic/Prebiotic Supplement
  • Placebo Gel

Treatment groups

80 Participants
are divided into 4 treatment groups