Evaluation of Bacillus Subtilis R0179 in Capsules on Gastrointestinal Survival, Transit Time, Gastrointestinal Symptoms, and General Wellness in Healthy Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
研究概览
简要总结
The purpose of this study is to evaluate the effect of three doses of the probiotic B. subtilis (Bacillus subtilis R0179) delivered in capsules on gastrointestinal and general wellness in healthy young adults, survival through the gastrointestinal tract and impact on intestinal microbes.
详细描述
A 6 week randomized, double blind placebo controlled trial in healthy young adults aged 18 to 50. Participants will be administered an oral dose of B. subtilis or placebo (1 capsule/day) for a period of 4 weeks. Viable counts will be measured from stool samples to assess transit survival, daily questionnaires (DQ) will be administered to assess general wellness, and gastrointestinal (GI) symptoms will be evaluated three times with the Gastrointestinal Symptom Response Scale (GSRS) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants
- •Are 18-50 years of age
- •Are willing and able to complete the Informed Consent Form in English
- •Are willing to complete the GPAQ (Global Physical Activity Questionnaire) at baseline and during the last week of the study as well as completing the GSRS (Gastrointestinal Symptom Response Survey) questionnaire at baseline, during treatment and post treatment
- •Are currently "moderately active" as determined by the GPAQ (Global Physical Activity Questionnaire)
- •Are willing to have height and weight measured and to provide demographic information (age, race, sex)
- •Are willing to consume B. subtilis R0179 (approximate doses of 1, 10, or 0.1 billion CFU per day) or placebo for a 28 day period by capsule (1 per day)
- •Are willing to complete daily questionnaires regarding general and gastrointestinal wellness for the duration of the study
- •Are willing to provide 1 stool at baseline, 1 stool during week 4 of the treatment and 1 stool after 7 days of washout
- •Are willing to provide a social security number to receive study payment. Note: the subject can still participate if unwilling to provide social security number, but no financial reimbursement can be provided
- •Are willing to have internet access for the duration of the study
排除标准
- •Potential Participants will be excluded if they
- •Do not meet the inclusion criteria
- •Are currently taking medications for constipation or diarrhea
- •Have taken antibiotics within the past four weeks prior to randomization
- •Are currently taking probiotics supplements and do not want to discontinue a minimum of two weeks prior to the study
- •Known to have or are currently being treated for any diseases or illnesses such as gastrointestinal disease (gastric ulcers, Crohn's, ulcerative colitis, etc.), other chronic diseases (diabetes, kidney disease, etc.) or immune-compromising diseases or conditions (HIV, AIDS, autoimmune, hepatitis, cancer, transplant patient etc.)
结局指标
主要结局
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for GI Distress
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Behavioral
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Gastrointestinal Symptoms Using Questionnaires
时间窗: Weeks 1, 5, and 6
Gastrointestinal Symptom Questionaires (GSRS) was administered during weeks 1, 5, and 6 of the study to evaluate gastrointestinal symptoms. The scale ranges from 1 (no discomfort at all) to 7 (very severe discomfort).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Epidermal
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Ear, Nose, and Throat (ENT)
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Hours of Sleep
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Participants recorded the number of hours they slept on the daily questionnaire.
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Cephalic
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Constipation
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Satiety
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Emetic
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Fatigue
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Diarrhea
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
Evaluation of the Effect of B. Subtilis R0179 on Wellness Questionnaires for Bowel Movement
时间窗: Weekly for 6 weeks
Daily Questionnaires consists of 24 symptom items evaluating general wellness. Participants filled out questionnaires nightly for the entire duration of the study (6 weeks). Daily scores were then averaged into weekly scores for each participant. Daily scores from weeks 2 - 5 were then averaged to arrive at a single value. Rating is scored from 0 (no symptoms) to 6 (very severe symptoms).
次要结局
- Evaluation of the Survival of B. Subtilis R0179 and Analyzing the Microbial Diversity in Stool Samples by Participants (Microbiota Study)(6 weeks)