NCT07276009尚未招募不适用
The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in Gastrointestinal Symptom Rating Scale
研究概览
简要总结
The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:
- Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?
- Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.
Participants will:
- Take one capsule of the probiotic or placebo once daily before meals for 60 days
- Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months
- Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months
- Attend scheduled study visits for checkups and assessments
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- 否
入选标准
- •Age 18-65 years
- •Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:
- •Postprandial fullness
- •Early satiation
- •Epigastric pain or burning
- •(with no evidence of structural disease explaining symptoms)
- •Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)
- •Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)
- •Negative for H. pylori (either previously treated successfully or tested negative within study screening)
- •Ability and willingness to provide informed consent and comply with study procedures
- •Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)
排除标准
- •Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy
- •History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)
- •Positive test for H. pylori during screening (or untreated known infection)
- •Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol
- •Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment
- •Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap
- •Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence
- •Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)
- •Pregnancy or lactation, or intention to become pregnant during the study period
- •Participation in another clinical trial within the past 3 months
- •Known allergy or intolerance to study product components
结局指标
主要结局
Change in Gastrointestinal Symptom Rating Scale
时间窗: 30 and 60 days
次要结局
未报告次要终点
研究者
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