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| ID | Type | Description | Link |
|---|---|---|---|
| OCR22502 | Other Identifier | UF OnCore | |
| 1R01DK121130-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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While genetics demonstrated a major risk factor for the development of type 1 diabetes (T1D), microbiota dysbiosis has been suggested as an elicitor in immunological tolerance and of beta cell autoimmunity. The probiotic Lactobacillus johnsonii N6.2 may prevent or restore the gut flora and show systemic impacts and adaptive immunity in the T1D population thereby preserving beta cell function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | Active Comparator | The probiotic group will receive a daily capsule with Lactobacillus johnsonii N6.2 1x109 Colony Forming Units (CFUs). Participants will consume one capsule (treatment or placebo) daily for 24 weeks. |
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| Placebo Group | Placebo Comparator | The placebo group will receive a capsule daily with dried skim milk (vehicle of the probiotic). Participants will consume one capsule (treatment or placebo) daily for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L. johnsonii Probiotic | Drug | Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP) | CBC and CMP will be evaluated at four different time points during study: 1st measure will be at screening visit and before starting intervention (visit 1/week -4, baseline period), 2nd measure will be after 12 weeks after starting intervention (visit 2/ week 12), 3rd measure will be after the 24 weeks of intervention (visit 3/ week 24) and the 4th measure will be 24 weeks later, end of washout period (visit 4/week 48). Values should be within the normal range except for glucose. | 52 weeks |
| Tolerance will be evaluated according to their responses on weekly questionnaires | The weekly questionnaire will ask participants to respond to questions regarding their gastrointestinal health (bowel movement frequency, gastrointestinal and other symptoms (i.e., constipation, diarrhea, stomach pain) and general wellness (if you consumed an antibiotic, visited a doctor, etc.). The questionnaires follow a scale from 1-7, 1 = No discomfort at all, 7 = Very severe discomfort. | 52 weeks |
| Adverse Event and/or Serious Adverse Event | Adverse Event and/or Serious Adverse Event will be recorded daily by parents and notified to investigator within 24 hrs., in particular gastro-intestinal symptoms, fever and rashes. | 24 weeks |
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Inclusion Criteria:
Have confirmed T1D by physician diagnosis
Have normal values at screening for CBC and complete metabolic profiles (with the exception of fasting glucose and HbA1c).
Are able to swallow a capsule.
Are willing to complete weekly online questionnaires.*
Are willing to consume a probiotic or placebo capsule daily for 24 weeks.
Are willing to provide stool samples throughout the study.
Are willing to provide blood samples throughout the study.
Are willing to take three 2-hour Mixed-Meal Tolerance Tests (MMTTs).
Are able to access a computer with Internet throughout the study.*
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Haller | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Clinical Research Center | Gainesville | Florida | 32610 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2022 | Apr 8, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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A randomized, double-blinded, placebo-controlled clinical trial will be carried out in subjects between 18-45 years old with T1D.
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| Placebo Capsule | Drug | Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks. |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |