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

ConditionDiabete Type 1

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

This trial accepts healthy volunteers

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

Design model

Factorial

Treatments tested in this trial

Probiotic/Prebiotic Supplement
Dietary 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
Dietary supplement
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.

Treatment groups

80 Participants

are divided into 4 treatment groups

Group A: Type 1 Diabetes - SupplementExperimental treatment 1 intervention

Group B: Type 1 Diabetes - PlaceboExperimental treatment 1 intervention

Group C: Healthy Controls - SupplementExperimental treatment 1 intervention

Group D: Healthy Controls - PlaceboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in gut microbiota composition

Variation in the relative abundance and diversity of gut microbiota species assessed by 16S rRNA sequencing from stool samples collected at baseline and after 98 days of intervention.

Time frame