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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* 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.
* No use of antibiotics, probiotics, or prebiotics during the 4 weeks prior to the study start.
* Willingness to comply with the study protocol and attend scheduled visits.
Exclusion Criteria:
* 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.
* Immunosuppressive diseases, active cancer, or treatment with immunosuppressants.
* Known allergy or intolerance to any component of the supplement or placebo.
* Excessive alcohol or drug use.
Primary outcome measure(s)
Change in gut microbiota composition — Baseline and 98 days post-intervention 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.
Trial sites (1)
Facility
City
Region
Status
UCAM San Antonio Catholic University of Murcia
Murcia
Murcia
More Universidad Católica San Antonio de Murcia trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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