Evaluation of the Safety, Tolerability and Immunological Response to Lactobacillus Johnsonii N6.2 in Children and Adolescents With T1D
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Adverse Event and/or Serious Adverse Event
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have confirmed T1D by physician diagnosis
- •have normal values at screening for complete blood count (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
- •are willing to provide stool samples throughout the study
- •are willing to provide blood samples throughout the study
- •are willing to take three stimulated C-peptide tests
- •are able to access a computer with Internet throughout the study
排除标准
- •being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's disease, ulcerative colitis, etc.)
- •being treated for chronic kidney disease
- •have had or are currently being treated for other immune-compromising diseases or conditions (HIV, AIDS, hepatitis, cancer, leukemia, organ transplant, Lupus, DiGeorge syndrome, selective deficiency of Immunoglobulin A (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 a minimum 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 the next 6 months
- •have a known allergy to milk or milk protein.
研究组 & 干预措施
Probiotic Group
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.
干预措施: L. johnsonii Probiotic (Drug)
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.
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Adverse Event and/or Serious Adverse Event
时间窗: 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.
Tolerance will be evaluated according to their responses on weekly questionnaires
时间窗: 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.
Safety will be evaluated according to complete blood count (CBC) and complete comprehensive metabolic panel (CMP)
时间窗: 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.
次要结局
未报告次要终点