Status:
COMPLETED
Modulation of Type 1 Diabetes Susceptibility Through the Use of Probiotics
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Type1diabetes
Type1 Diabetes Mellitus
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
Investigators aim to further the understanding of environmental factors that underlie the progression to Type 1 diabetes (T1D). Dysbiosis, defined as alterations in intestinal microbiota composition a...
Eligibility Criteria
Inclusion
- Males and females 5-17 years of age
- Full-sibling of an individual with a clinical diagnosis of Type 1 diabetes
- Treatment naïve of any immunomodulatory agent
- Naïve of any probiotic supplement within the past 12 months
Exclusion
- Presence of severe/active disease that interferes with dietary intake
- Chronic use of medications known to affect gastrointestinal function, such as stool softeners or laxatives
- Diagnosis of celiac disease and/or following a gluten-free diet
- Presence of significant and sustained gastrointestinal symptoms within the prior 6 weeks (e.g., severe abdominal pain, worsening constipation, diarrhea, or recurrent nausea +/- vomiting)
- Chronic inflammatory or autoimmune disease with the exception of well-controlled hypothyroidism or intermittent or mild persistent asthma not requiring the use of daily inhaled steroids
- Use of any medications that could affect intestinal microbiota within the previous 3 months (e.g., antibiotics, prebiotics, or probiotics)
- Any condition that, in the investigator's opinion, may compromise study participation or may confound the interpretation of the study results
- Female participants of child-bearing age must not be pregnant
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03423589
Start Date
April 23 2018
End Date
December 31 2018
Last Update
July 22 2024
Active Locations (1)
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1
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226