NCT07276009已完成不适用
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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 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
研究组 & 干预措施
Probiotic group
Experimental
L. rhamnosus LR110, B. lactis BI040, B. breve BB010, L. paracasei LPC100, L. acidophilus LA120, L. casei LR130, L. plantarum LP140, S. thermophilus ST250, B. longum BL020, B. bifidum BF030 5 billion CFU one time daily for 60 days
干预措施: Lactobacillus (Other)
Placebo group
Placebo Comparator
Product with excepients without probiotic bacteria one time daily for 60 days
干预措施: Maltodextrin (Placebo) (Other)
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
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Effect of Probiotics, Double Antibiotic Paste, and Calcium Hydroxide on Postoperative Pain in Irreversible Pulpitis: A Randomized TrialRoot Canal TreatmentPulpitis - IrreversiblePost Operative Pain, AcuteIrreversible Pulpitis With Apical PeriodontitisNCT07270159Dow University of Health Sciences75
进行中（未招募）
不适用
The Impact of Probiotics on Bariatric Treatment OutcomesObesity & OverweightNCT07258732University of Warmia and Mazury in Olsztyn200
招募中
不适用
Women's Hormonal and Metabolic Wellbeing StudyMetabolic HealthNCT07268404Daily Nouri60
已完成
不适用
A Clinical Trial to Evaluate the Effects of a Chickpea Pasta on Gut Health, Blood Glucose, and Overall HealthGut HealthGastrointestinal HealthNCT07264465Banza LLC12
已完成
不适用
The Efficacy of a Probiotic for Antibiotic Associated Gastrointestinal SymptomsAntibiotic-associated DiarrheaNCT05845073The Archer-Daniels-Midland Company69