HAMS-AB in Newly Diagnosed Patients With Type 1 Diabetes (HAMS-AB-01B)
Type 1 Diabetes, Type 1 Diabetes (Juvenile Onset), Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes
Eligibility Criteria
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
Sites / Locations
- Indiana School of Medicine
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
HAMS-AB, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS)
FOOD STARCH, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS)