Phase
Condition
Diabetes Mellitus, Type 1
Treatment
L. johnsonii Probiotic
Placebo Capsule
Clinical Study ID
Ages 18-45 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have confirmed T1D by physician diagnosis
Have normal values at screening for CBC and complete metabolic profiles (with theexception 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.*
Note: Going into the study, we want the participants to have daily internetaccess. However, if this changes once they are in the study, we will providepaper copies of the questionnaires.
Exclusion
Exclusion Criteria:
Have had or are currently being treated for any diseases or illnesses such asgastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.).
Have chronic disease kidney disease.
Have had or are currently being treated for other immune-compromising diseases orconditions (HIV, AIDS, hepatitis, cancer, leukemia, transplant patient, Lupus,DiGeorge syndrome, selective deficiency of IgA, Bruton's disease etc.).
Have an underlying structural heart disease.
Currently live with an immunocompromised person.
Are currently taking medications for constipation and/or diarrhea.
Have taken antibiotics within the past 2 weeks prior to randomization.
Are currently taking a probiotic supplement and are unwilling to discontinue it aminimum of 2 weeks prior to the study start.
Are a current smoker.
Are currently pregnant or lactating or a female who plans to become pregnant in thenext 6 months.
Have a known allergy to milk or milk protein.
Study Design
Connect with a study center
UF Clinical Research Center
Gainesville, Florida 32610
United StatesSite Not Available
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