NCT06320379招募中不适用
Evaluating Changes in Quality of Life and Digestion in Functional Dyspepsia in Adults
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Protein Assimilation
研究概览
简要总结
The purpose of this study is to determine the effects of a readily available dietary supplement on quality of life and digestion in adults with functional dyspepsia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •● Adults 18-70 years of age (inclusive)
- •A self-reported history of symptoms consistent with Functional Dyspepsia (per Rome IV criteria - See Telephone Screening), and self-reported absence of organic disease and infection (e.g., Helicobacter pylori) with or without a formal diagnosis by a healthcare professional.
- •Adults ≥ 60 years of age must have had a normal upper gastrointestinal endoscopy
- •Willing to be randomized to take a daily dietary supplement or placebo over the 4-week study period
- •Not taken antibiotics or other drugs prescribed specifically for symptoms consistent with Functional Dyspepsia (per Rome IV criteria) for a period up to 1 month before the beginning of the study.
- •On a stable dose of all medications prior to study entry (i.e., consistent dose for a minimum of three months)
- •On a stable dose of dietary supplements for at least one month prior to enrollment
- •Willing to avoid initiation of new supplements and/or medications unless otherwise indicated by a healthcare professional
- •Able to communicate via email, complete computer-administered questionnaires, and to read and write in English.
- •Approved to be eligible for study participation at the discretion of the Principal Investigators, after review of the Formal Eligibility Screen results.
- •Non-smokers (including tobacco and cannabis products, combusted or vaporized)
- •Willing to provide written informed consent and to follow the required protocol
排除标准
- •● A self-reported history of peptic and/or duodenal ulcers, H. pylori infection, gastroesophageal reflux disease (GERD) explained by upper endoscopy, irritable bowel syndrome (IBS), and other chronic GI disorders.
- •Positive fecal occult blood test (FOBT) at the clinical screening visit
- •Current use of digestive enzyme and/or betaine HCL-containing dietary supplements
- •Current use of prescribed proton-pump inhibitors
- •Current use of drugs that interfere with gastrointestinal motility, including prokinetic agents.
- •History of previous abdominal surgery, including gastric surgery, excluding appendectomy.
- •Individuals with chronic kidney or liver disease, cancer, colorectal disease and/or other rare disorders that at the discretion of the PI or Clinical Investigator may impact their safety or confound trial results
- •Current involvement or within 14 days prior to screening of a significant diet or weight loss program (such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet programs) or very low-calorie liquid diet programs (such as Optifast, Medifast, and/or HMR)
- •Hospitalization (for any reason other than a scheduled medical procedure unrelated to Functional Dyspepsia) within 3 months prior to screening
- •Malignancy within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
- •Intake of ≥ 2 standardized alcohol-containing beverages per day, 14 per week, or ≥4 in any single day within the past 14 days.
- •Individuals who do not consume, or are allergic to, animal products
- •Smoking tobacco or nicotine products (combusted or vaporized)
- •Use of illicit drugs/substances (such as but not limited to cocaine, phencyclidine (PCP), and methamphetamine) within 14 days of screening
- •Currently participating in another interventional research study, or participated in another interventional research study within 14 days of screening
结局指标
主要结局
Protein Assimilation
时间窗: Week 4
Concentrations of Amino Acids in Blood
次要结局
- Mineral concentrations in blood(Week 4)
- Patient Reported Outcomes Measurement Information System (PROMIS)-29 Physical Function Subscale(Week 4)
- Leeds Dyspepsia Questionnaire(Week 4)
- Fat-soluble vitamin concentration in blood(Baseline)
- Fat-soluble vitamins(Week 4)
研究者
Ryan Bradley
Director of Research
National University of Natural Medicine
研究点 (2)
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