HAMS-AB-01B: HAMS-AB in Newly Diagnosed Patients With Type 1 Diabetes
Study Details
Study Description
Brief Summary
Evaluating the adverse events and tolerance of HAMS-AB in Mitigating Type 1 Diabetes in Newly Diagnosed Patients
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of HAMS-AB in newly diagnosed Type 1 Diabetes adolescents
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Active Comparator HAMS-AB, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS) |
Drug: HAMS-AB
Modified Superior Starch
|
| Placebo Comparator: Placebo Comparator FOOD STARCH, TAKEN TWICE A DAY, ORALLY WITH FOOD FOR 12 WEEKS (84 DAYS) |
Other: Placebo
Food Grade Starch
|
Outcome Measures
Primary Outcome Measures
- Measurement of adverse events from the date of the first dose through 12 weeks of HAMS-AB tolerance [12 Weeks]
The number of participants with treatment-related adverse events as evaluated by CTCAE v5.0, will be reviewed to see the results from baseline in toxicology scores at 12 Weeks compared to placebo.
Secondary Outcome Measures
- Measurement of clinical activity and to determine the gut microbiome profile in youth with recently diagnosed Type 1 Diabetes [12 Weeks]
To measure the levels of glucose (in milligrams) in the blood at the beginning and again at 12 weeks, and the measurement of C-Peptide (in nanograms) in the blood at the beginning and again at 12 weeks versus placebo, changes in the type of gut bacteria at the beginning and again at 12 weeks versus placebo.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana School of Medicine | Indianapolis | Indiana | United States | 46202 |
Sponsors and Collaborators
- Rise Therapeutics LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HAMS-AB-01B