Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.
Methods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor.
The treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.
- •Aged 18 to 80 years, regardless of gender.
- •Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.
排除标准
- •Use of probiotics or antibiotics within one month prior to the trial.
- •Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.
- •Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.
- •Participation in any other clinical trial within one month prior to the study.
- •Positive test for Helicobacter pylori (Hp) infection.
- •Long-term use of traditional Chinese herbal medicine.
- •Pregnancy or lactation.
- •History of drug abuse.
- •Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc.
- •History of major surgery or diagnosis of diabetes mellitus.
- •Refusal to provide written informed consent.
研究组 & 干预措施
The probiotic group
Probiotic Group:
Patients with postprandial distress syndrome (PDS) will receive Mosapride Citrate Tablets 5 mg three times daily, along with Clostridium butyricum 1260 mg twice daily.
Patients with epigastric pain syndrome (EPS) will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, along with Clostridium butyricum 1260 mg twice daily.
干预措施: Clostridium butyricum (Drug)
The placebo group
Placebo Group:
Patients with PDS will receive Mosapride Citrate Tablets 5 mg three times daily, plus a placebo identical in appearance and odor to Clostridium butyricum (with identical dosage and frequency).
Patients with EPS will receive Esomeprazole Enteric-Coated Tablets 20 mg once daily, plus a placebo identical in appearance and odor to Clostridium butyricum (with identical dosage and frequency).
干预措施: placebo (Drug)
结局指标
主要结局
Hospital Anxiety and Depression Scale (HADS)
时间窗: 4 weeks
Hospital Anxiety and Depression Scale (HADS) is divided into an anxiety subscale (7 questions) and a depression subscale (7 questions), with each subscale scoring 0-21 points. The higher the score, the more severe the patient's anxiety and depression.
次要结局
- Overall Treatment Evaluation (OTE) questionnaire(4 weeks)
- Global Overall Symptom scale (GOS score)(4 weeks)
- Short-form Nepean Dyspepsia Index (SF-NDI)(4 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(4 weeks)
研究者
Yongquan Shi
Professor
Xijing Hospital of Digestive Diseases