R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

Prior treatment

• Any COVID vaccines within 30 days prior to Day 1

Other illness

• 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
• Allergy to corn (prebiotic), milk allergy, soy (present in the MMTT meal) or their products
• 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)

Other

• Pregnancy or possible pregnancy
• Participation in other intervention research trials within the past three (3) months
• 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)

• 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