NCT07033000尚未招募不适用
A Randomized, Placebo Controlled Clinical Study to Assess the Effect of a Blend of Digestive Enzymes andDandelion, Ginger & Fennel Extracts on Bloating in Adults.
Olly, PBC2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- To determine the impact of BTB on hydrogen and methane production in healthy adults
研究概览
简要总结
Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study, where participants will take the Daily Supplement, and record Daily Symptoms, two clinical visits where Hydrogen and Methane Breath Test (HMBT) will be conducted, Abdominal Circumference Measurement will be taken, and two Self Reported Validated Questionnaires: Visual Analogue Scale (VAS) and the Quality of Life Questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adults aged 18-65 years
- •Reported bloating and/or distention occurring at least once per week for the past 6 months, with symptoms actively present during the past 3 months
- •Willingness to avoid probiotics, antibiotics, or other supplements during the study period (unless approved by investigators)
- •Ability to provide informed consent and comply with all protocol requirements
排除标准
- •Diagnosed gastrointestinal diseases (e.g., inflammatory bowel disease, celiac disease, GI malignancies)
- •Use of antibiotics, laxatives, or probiotics within the past 4 weeks
- •Uncontrolled diabetes mellitus
- •Presence of mood disorders or psychiatric illness that may affect symptom perception or study compliance
- •Immunodeficiency, autoimmune conditions, or chronic inflammatory conditions
- •Excessive alcohol intake (>14 drinks/week for men, >7 drinks/week for women)
- •Use of medications known to affect gut motility or gas production (e.g., opioids, anticholinergics)
- •Pregnant or breastfeeding women
- •Use of systemic corticosteroids or immunosuppressant drugs.
- •History of reaction to the category of product tested
- •Other diseases or medications that might directly interfere in the study or put the subject's health under risk.
- •Employee of CRO or product manufacturer
结局指标
主要结局
To determine the impact of BTB on hydrogen and methane production in healthy adults
时间窗: From time of enrollement to end of study at Week4
Participants will take the Hydrogen and Methane Breath Test (HMBT) at baseline and after the study at Week4.
次要结局
- To estimate the changes in abdominal circumference as an indicator of distention(From time of enrollement to end of study at Week4)
- To assess the changes in validated subjective questionnaire (VAS) for bloating, abdominal pain, distension, and flatulence.(From time of enrollement to end of study at Week4)
研究者
研究点 (2)
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