Effects of a Probiotic Supplement on Gastrointestinal Symptoms and Microbiome Modulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Abdominal discomfort
研究概览
简要总结
This randomized, placebo-controlled, double-blind study will determine the effect of daily supplementation with a probiotic blend in 60 apparently healthy men and women recruited at a single investigational center in Northeast Ohio (i.e., The Center for Applied Health Sciences).
Subjects will attend three study visits. During Visit 1, subjects will be screened for participation [i.e., medical history, routine blood work, background baseline diet]. During Visits 2 and 3 subjects will complete questionnaires that assess their gastrointestinal health (e.g., abdominal discomfort/bloating, constipation, regularity, stool consistency). Visits 2 and 3 will correspond to before (week 0) and after six weeks of supplementation, respectively, with the probiotic dietary supplement or placebo.
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
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all participants were required to be between 30-60yr
- •score ≥12 on the GSRS
- •have a body mass ≥120 pounds (54.5kg)
- •body mass index (BMI) between 20.0-34.99kg/m2
- •normotensive (<140/<90mmHg)
- •normal resting heart rate (<90bpm)
排除标准
- •Female participants who were pregnant or nursing
- •history of unstable or new-onset cardiovascular or cardiorespiratory disease;
- •stroke, diabetes, or other endocrine disorder;
- •use of any nutritional supplement known to alter the gut microbiota/microflora;
- •use of probiotic supplements or prebiotic supplements in the previous 4 weeks and for the duration of the study;
- •use of any antibiotics, antifungals, antivirals, or antiparasitic within 8 weeks of the start of the study or throughout the study;
- •any changes in diet within 4 weeks of study start date or throughout study duration;
- •if the participant was unwilling to abstain from gut altering supplements for the study;
- •malignancy in the previous 5yr except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin);
- •prior gastrointestinal bypass surgery (i.e., Lapband);
- •any known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism [e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU)];
- •any chronic inflammatory condition/disease (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, HIV/AIDS, etc.);
- •known sensitivity to any ingredient in the test formulations as listed in the certificates of analysis.
- •currently participating in another research study with an investigational product or had participated in another research study in the past 30 days
- •any other diseases/conditions that, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.
结局指标
主要结局
Abdominal discomfort
时间窗: Change from baseline to 6 weeks.
Abdominal discomfort as measured by a 10 cm visual analogue scale, where higher values represent greater discomfort.
Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Change from baseline to 6 weeks.
Gastrointestinal problems as measured by the GSRS questionnaire, where higher values represent increased severity of gastrointestinal problems.
Flatulence (gas)
时间窗: Change from baseline to 6 weeks.
Flatulence (gas) as measured by a 10 cm visual analogue scale, where higher values represent greater flatulence.
Gastro-intestinal bloating
时间窗: Change from baseline to 6 weeks.
Gastro-intestinal bloating as measured by a 10 cm visual analogue scale, where higher values represent greater bloating.
次要结局
- Stool consistency(Change from baseline to 6 weeks.)
- Stool regularity(Change from baseline to 6 weeks.)
- Constipation(Change from baseline to 6 weeks.)