R-5280 in Newly Diagnosed Patients With Type 1 Diabetes (NCT06057454) | Clinical Trial Compass
CompletedPhase 1
R-5280 in Newly Diagnosed Patients With Type 1 Diabetes
United States9 participantsStarted 2023-12-05
Plain-language summary
Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
Who can participate
Age range
11 Years – 17 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:
* Newly Diagnosed children (age 11-17 years old)
* BMI \<85%
* Diagnosed by ADA criteria with T1D within 2 years
* Accepted to adhere to a healthy diabetic diet as recommended by the ADA
Exclusion Criteria:
* Monogenic forms of diabetes or type 2 diabetes
* History of ongoing infection or antibiotic treatment within the past four (4) weeks
* History of immunocompromised, recurrent infections, steroid intake (inhaled or oral forms) or other immunosuppressant use in the past six (6) months
* History of chronic gastrointestinal disease, possible or confirmed celiac disease
* Pregnancy or possible pregnancy
* Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
* Participation in other intervention research trials within the past three (3) months
* Anticipated major change in diabetes management during the study (e.g., change from injections to insulin pump therapy or new continuous monitor usage, all known to significantly alter glycemia)
* Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of high fiber foods on four (4) or more days per week) or any fiber supplements will be excluded (to be assessed at screening)
* Any COVID vaccines within 30 days prior to Day 1
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.
What they're measuring
1
Measurement of adverse events from the date of the first dose through 12 weeks of R-5280 tolerance