A Randomized Controlled Trial of a Commercially-Available Probiotic Supplement (Trenev Trio®/Healthy Trinity®) and the Promotion of Normal Gastrointestinal Function Among Adults With Recurrent Gastrointestinal Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Severity of self-reported indigestion
研究概览
简要总结
Participants experiencing recurrent gastrointestinal symptoms in this double-blind, randomized, controlled trial will receive either a commercially-available probiotic dietary supplement or placebo. The investigators hypothesize that participants in the probiotic dietary supplement group will experience greater improvement in their gastrointestinal symptoms than participants in the placebo group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported response of "moderate discomfort" or worse (3 or greater on 1-5 Likert Scale) and "frequent discomfort" or more often (3 or greater on 1-5 Likert scale) from at least 2 of the following gastrointestinal symptoms: gas, indigestion, bloating, abdominal pain, or defecation irregularity as expressed on Likert scale (1=very minor or no discomfort, 2=minor discomfort, 3=moderate discomfort, 4=high discomfort, 5=very high discomfort) over the previous 3 weeks
- •Agree to continue with typical diet and exercise habits during study
- •Agree to use contraception or abstinence throughout study period, unless postmenopausal or surgically sterile (females only)
- •Able to understand and voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
排除标准
- •Current and documented diagnosis of Inflammatory Bowel Disease (Crohn's disease or ulcerative colitis), Celiac disease, active peptic ulcer, active diverticulitis, and other active cases of gastrointestinal diseases that, in the investigators' opinions, may affect participant safety.
- •Current and documented diagnosis of any other non-gastrointestinal disease that, in the investigators' opinions, may affect participant safety or confound the evaluation of the study outcomes. Excluded conditions include congestive heart failure, malignancy, uncontrolled diabetes mellitus, uncontrolled autoimmune disease (lupus, rheumatoid arthritis, eczema), eating disorders, and any other active health condition or disease that the investigators feel contradict the intended study population of participants in good health.
- •Daily consumption of another probiotic supplement or new consumption of fermented dairy products (yogurt, kefir, etc.)
- •Usage of systemic steroids during the past 2 months
- •Usage of antipsychotic medications during the past 2 months
- •Usage of prednisone, 6-mercaptopurine, adalimumab, etanercept, infliximab, leflunomide, golimumab, or mycophenolate mofetil during the past 2 months
- •Uncontrolled anxiety or current medication for anxiety disorder
- •Pregnant or breastfeeding females
- •History of alcohol, drug, or medication abuse
- •Known allergies to any substance in the study product
- •Previous major gastrointestinal tract surgery (colon resection, gastric bypass, etc.)
- •Participation in another clinical trial within 30 days of screening
研究组 & 干预措施
Probiotic dietary supplement
Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of:
- Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU])
- Bifidobacterium bifidum Malyoth super strain (40 billion CFU)
- Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)
干预措施: Probiotic dietary supplement (Trenev Trio®) (Dietary Supplement)
Placebo
The placebo capsules utilized in this study will be indistinguishable from the probiotic dietary supplement capsules as they will be identical in appearance, odor, weight, and taste. Furthermore, the same sunflower oil matrix will be in both the probiotic dietary supplement and placebo. The only difference between the dietary supplement and placebo capsules will be the probiotic bacteria.
干预措施: placebo (Dietary Supplement)
结局指标
主要结局
Severity of self-reported indigestion
时间窗: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported gas
时间窗: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported abdominal pain
时间窗: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported defecation irregularity
时间窗: Study end (6 weeks from baseline)
Likert scale
Severity of self-reported bloating
时间窗: Study end (6 weeks from baseline)
Likert scale
次要结局
- Frequency of self-reported abdominal pain(Study end (6 weeks from baseline))
- Frequency of self-reported bloating(Study end (6 weeks from baseline))
- Frequency of self-reported defecation irregularity(Study end (6 weeks from baseline))
- Frequency of self-reported gas(Study end (6 weeks from baseline))
- Frequency of self-reported indigestion(Study end (6 weeks from baseline))
研究者
Chris D'Adamo
Assistant Professor Department of Family and Community Medicine Department of Epidemiology and Public Health Director of Research Center for Integrative Medicine
University of Maryland, Baltimore