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| Name | Class |
|---|---|
| Hengshui People's Hospital | OTHER |
| Hebei Medical University Third Hospital | OTHER |
| Beijing Jianjia Rehabilitation Hospital | UNKNOWN |
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To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The pregabalin group | Experimental | 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. |
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| The control group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The pregabalin group | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The IBS Severity Scoring System (IBS-SSS) and respnse rate | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The IBS Quality of Life (IBS-QOL) questionnaire | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fang Luo | Contact | +86 13611326978 | 13611326978@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Luo | Beijing Tiantan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
This requires permission from the corresponding author
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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Parallel Assignment
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The statisticians performing the final data analysis
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| Routine Treatment | Drug | 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. |
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| Up to 12 weeks after treatment |
| The Bristol Stool Form (BSF) scale | 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). | Up to 12 weeks after treatment |
| The Hospital Anxiety and Depression Scale (HADS) | 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. | Up to 12 weeks after treatment |
| The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score | 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. | Up to 12 weeks after treatment |
| The adverse events | The occurrence of the dizziness, somnolence, peripheral edema, dry mouth and weight gain | Up to 12 weeks after treatment |
| The time to first clinical response | The time to first clinical response | The time to first clinical response after treatment, up to 12 weeks after treatment |
| D004066 | Digestive System Diseases |