R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Description

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Conditions

Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset), Diabetes Mellitus, Type 1

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Study Overview

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Study Details

Study overview

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

R-5280 in Newly Diagnosed Patients with Type 1 Diabetes

Condition
Type 1 Diabetes
Intervention / Treatment

-

Contacts and Locations

Plantation

Edward Jenner Research Group LLC, Plantation, Florida, United States, 33317

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Kansas City

Spectrum Clinical Research, Kansas City, Missouri, United States, 64118

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

11 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rise Therapeutics LLC,

Study Record Dates

2025-09