Lactobacillus Johnsonii in Children and Adolescents With T1D
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|ClinicalTrials.gov Identifier: NCT03961854|
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : August 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes (T1D)||Drug: L. johnsonii Probiotic Drug: Placebo Capsule||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized, double-blinded, placebo-controlled clinical trial will be carried out with children and adolescents (8-less than 18 years old) with T1D (duration <1 year).|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D|
|Actual Study Start Date :||October 10, 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
Active Comparator: Probiotic Group
The probiotic group will receive a daily capsule with Lactobacillus johnsonii N6.2 1x109 CFUs. Participants will consume one capsule (treatment or placebo) daily for 24 weeks.
Drug: L. johnsonii Probiotic
Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
Placebo Comparator: Placebo Group
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.
Drug: Placebo Capsule
Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.
- Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP) [ Time Frame: 52 weeks ]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 values except for glucose.
- Tolerance will be evaluated according to their responses on weekly questionnaires [ Time Frame: 52 weeks ]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.
- Adverse Event and/or Serious Adverse Event [ Time Frame: 24 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961854
|Contact: Michael Haller, MDfirstname.lastname@example.org|
|Contact: Miriam Cintronemail@example.com|
|United States, Florida|
|UF Clinical Research Center||Recruiting|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Michael Haller||University of Florida|