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
- 1
- 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.
研究组 & 干预措施
Placebo
Consists of 575 mg rice oligodextrin
干预措施: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase (Dietary Supplement)
Active
Consists of 575mg [30 billion colony forming units probiotic blend of Bifidobacterium breve 19bx, Lactobacillus acidophilus 16axg, Lacticaseibacillus rhamnosus 18fx, Saccharomyces boulardii 16mxg, and alpha amylase
干预措施: 575mg [30 billion colony forming units] probiotic blend of Bifidobacterium breve, Lactobacillus acidophilus, Lacticaseibacillus rhamnosus, Saccharomyces boulardii, and alpha amylase (Dietary Supplement)
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.)