Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 D… (NCT07062224) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of a Probiotic Supplement on Gut Microbiota and Glycemic Control in Patients With Type 1 Diabetes (PRODIAB)
Spain80 participantsStarted 2025-09
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.