Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome
2026年6月23日 更新者：Fang Luo、Beijing Tiantan Hospital
Efficacy and Safety of Pregabalin in Patients With Irritable Bowel Syndrome : A Multi-center Prospective Randomized Open Blinded End-point Trial
To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).
研究概览
详细说明
The investigators aim to investigate the efficacy of pregabalin in patients with irritable bowel syndrome (IBS), and to explore the etiology of IBS and the effective and rapid treatment for this etiology.
研究类型
介入性
注册 (估计的)
258
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Fang Luo
- 电话号码：+86 13611326978
- 邮箱：13611326978@163.com
学习地点
-
-
Beijing Municipality
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Beijing、Beijing Municipality、中国、100050
- 招聘中
- Beijing Tiantan Hospital
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Age range: 18-70 years old;
- According to the Rome IV diagnostic criteria for IBS, the screening result is positive;
- Mild to moderate IBS patients assessed based on the IBS-SSS.
Exclusion Criteria:
- Concurrent gastrointestinal conditions presenting with symptoms potentially overlapping with those of IBS, significant medical comorbidities;
- Severe mental disorders associated with marked personality disturbances, active suicidal thoughts or any self harm episodes within the preceding 12 months;
- Current or intended pregnancy or lactation;
- Cognitive impairment;
- Recent use of pregabalin (within 30 days) or known allergy to pregabalin;
- Concomitant use of medications that may interact with the study drug, mimic its effects, or aggravate expected adverse reactions (including but not limited to rosiglitazone, pioglitazone, opioids, anxiolytics, non opioid analgesics, mexiletine, dextromethorphan, and sedative hypnotics);
- Use of IBS specific agents such as alosetron;
- Consumption exceeding 50 units of alcohol weekly (where 1 unit corresponds to 10 mL of pure alcohol).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：The pregabalin group
75 mg twice daily for 3 days, followed by 150 mg twice daily for 3 days during the first week; 225 mg twice daily at week 10; and a tapering regimen at week 12 (150 mg twice daily for 3 days, then 75 mg twice daily for 3 days).
Patients also received routine treatment from gastroenterologists. Patients also received routine treatment from gastroenterologists. Loperamide: 2-4 mg after each loose stool (max 16 mg/day) to reduce stool frequency, though it does not relieve pain.
Rifaximin: 550 mg TID for 14 days (repeatable); or Eluxadoline 100 mg BID (75 mg BID in post-cholecystectomy patients), which is contraindicated in pancreatitis or biliary obstruction.
Antispasmodics: Dicyclomine: 10-20 mg QID or Hyoscyamine as needed for cramping.
|
75 mg twice daily for 3 days, followed by 150 mg twice daily for 3 days during the first week; 225 mg twice daily at week 10; and a tapering regimen at week 12 (150 mg twice daily for 3 days, then 75 mg twice daily for 3 days).
Patients also received routine treatment from gastroenterologists. Loperamide: 2-4 mg after each loose stool (max 16 mg/day) to reduce stool frequency, though it does not relieve pain.
Rifaximin: 550 mg TID for 14 days (repeatable); or Eluxadoline 100 mg BID (75 mg BID in post-cholecystectomy patients), which is contraindicated in pancreatitis or biliary obstruction.
Antispasmodics: Dicyclomine: 10-20 mg QID or Hyoscyamine as needed for cramping.
|
|
其他：The control group
The control group only received routine treatment from gastroenterologists. Patients also received routine treatment from gastroenterologists. Loperamide: 2-4 mg after each loose stool (max 16 mg/day) to reduce stool frequency, though it does not relieve pain.
Rifaximin: 550 mg TID for 14 days (repeatable); or Eluxadoline 100 mg BID (75 mg BID in post-cholecystectomy patients), which is contraindicated in pancreatitis or biliary obstruction.
Antispasmodics: Dicyclomine: 10-20 mg QID or Hyoscyamine as needed for cramping.
|
Patients also received routine treatment from gastroenterologists. Loperamide: 2-4 mg after each loose stool (max 16 mg/day) to reduce stool frequency, though it does not relieve pain.
Rifaximin: 550 mg TID for 14 days (repeatable); or Eluxadoline 100 mg BID (75 mg BID in post-cholecystectomy patients), which is contraindicated in pancreatitis or biliary obstruction.
Antispasmodics: Dicyclomine: 10-20 mg QID or Hyoscyamine as needed for cramping.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The IBS Severity Scoring System (IBS-SSS) and respnse rate
大体时间：Up to 12 weeks after treatment
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The primary outcome was assessed using the IBS-SSS and response rate, subgroup analyses were performed stratified by gender, age, and body mass index (BMI).
|
Up to 12 weeks after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The IBS Quality of Life (IBS-QOL) questionnaire
大体时间：Up to 12 weeks after treatment
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The IBS Quality of Life (IBS-QOL) questionnaire at baseline and at 4, 8, and 12 weeks, which consists of 8 subscales (dysphoria, activity interference, personal image, health concerns, food avoidance, social reaction, sexuality, social relationship), with a total of 34 questions.
Each subscale score ranges from 0 to 100 points.
A higher score indicates a better quality of life.
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Up to 12 weeks after treatment
|
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The Bristol Stool Form (BSF) scale
大体时间：Up to 12 weeks after treatment
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The Bristol Stool Form (BSF) scale at baseline and at 4, 8, and 12 weeks, which is used to record the difference in proportions of the patient's daily bowel habits (hard stools, normal stools, and loose stools).
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Up to 12 weeks after treatment
|
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The Hospital Anxiety and Depression Scale (HADS)
大体时间：Up to 12 weeks after treatment
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The Hospital Anxiety and Depression Scale (HADS) at baseline and at 4, 8, and 12 weeks, which consists of two sub-scales.
Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression.
A score of 11 or above can indicate clinically significant anxiety or depression.
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Up to 12 weeks after treatment
|
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The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score
大体时间：Up to 12 weeks after treatment
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The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score at baseline and at 4, 8, and 12 weeks, which includes 12 extra-GI symptoms such as back pain, limb pain, and headache.
A higher score indicates more severe somatization symptoms.
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Up to 12 weeks after treatment
|
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The adverse events
大体时间：Up to 12 weeks after treatment
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The occurrence of the dizziness, somnolence, peripheral edema, dry mouth and weight gain
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Up to 12 weeks after treatment
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The time to first clinical response
大体时间：The time to first clinical response after treatment, up to 12 weeks after treatment
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The time to first clinical response
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The time to first clinical response after treatment, up to 12 weeks after treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Fang Luo、Beijing Tiantan Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月7日
初级完成 (实际的)
2026年4月8日
研究完成 (估计的)
2029年3月31日
研究注册日期
首次提交
2026年5月17日
首先提交符合 QC 标准的
2026年6月7日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月25日
上次提交的符合 QC 标准的更新
2026年6月23日
最后验证
2026年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.