NCT07062224Not yet recruiting
Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)
Impact of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes Mellitus: A Randomized Double-Blind Clinical Trial
Source: ClinicalTrials.gov · Last updated 14 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 2 Jul 2025
- Start date
- Sept 2025
- Primary completion date
- Nov 2025
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Diseases
- Type 1 diabetes
- NCT number
- NCT07062224
What you commit to
- Study type: Interventional
- Planned participants: 80
- From Sept 2025 to the primary completion date, Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunosuppressive diseases, active cancer, or treatment with immunosuppressants.
- Excessive alcohol or drug use.
Other illness
- Chronic gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).
- Known allergy or intolerance to any component of the supplement or placebo.
Other
- Current use of probiotics, prebiotics, or antibiotics.
- Pregnancy or breastfeeding.
- Participation in another clinical trial within the past 3 months.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UCAM San Antonio Catholic University of Murcia Coordinator of this site? Confirm its status | Murcia | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.