Clinical Trials

Inclusion Criteria:

• Newly diagnosed children (ages 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
• History of ketoacidosis, severe hypoglycemia, neuropathy, and nephropathy
• Use of metformin
• Suffering from Cushing Syndrome
• 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 to continuous glucose monitor usage, all known to significantly alter glycemia)
• Children consuming a high-fiber or vegetarian diet (consuming three (3) or more servings of highfiber 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

Although generally considered to be safe, HAMS-AB has not been specifically studied in pregnant women and therefore, females of childbearing age will be asked to use effective forms of Birth Control – any one of the following (additionally, participants will be counselled on the use of a second method of contraception):

• Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 4/8/2024. Questions regarding updates should be directed to the study team contact.