Irritable Bowel Syndrome (IBS)
Conditions
Keywords
Irritable Bowel Syndrome, pregabalin
Brief summary
To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).
Detailed description
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.
Interventions
DRUGThe 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).
DRUGRoutine Treatment
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.
Sponsors
Beijing Tiantan Hospital
Hengshui People's Hospital
Hebei Medical University Third Hospital
Beijing Jianjia Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The statisticians performing the final data analysis
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 18-70 years old; 2. According to the Rome IV diagnostic criteria for IBS, the screening result is positive; 3. Mild to moderate IBS patients assessed based on the IBS-SSS.
Exclusion criteria
1. Concurrent gastrointestinal conditions presenting with symptoms potentially overlapping with those of IBS, significant medical comorbidities; 2. Severe mental disorders associated with marked personality disturbances, active suicidal thoughts or any self harm episodes within the preceding 12 months; 3. Current or intended pregnancy or lactation; 4. Cognitive impairment; 5. Recent use of pregabalin (within 30 days) or known allergy to pregabalin; 6. 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); 7. Use of IBS specific agents such as alosetron; 8. Consumption exceeding 50 units of alcohol weekly (where 1 unit corresponds to 10 mL of pure alcohol).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The IBS Severity Scoring System (IBS-SSS) and respnse rate | Up to 12 weeks after treatment | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The IBS Quality of Life (IBS-QOL) questionnaire | Up to 12 weeks after treatment | 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. |
| The Bristol Stool Form (BSF) scale | Up to 12 weeks after treatment | 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). |
| The Hospital Anxiety and Depression Scale (HADS) | Up to 12 weeks after treatment | 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. |
| The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score | Up to 12 weeks after treatment | 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. |
| The adverse events | Up to 12 weeks after treatment | The occurrence of the dizziness, somnolence, peripheral edema, dry mouth and weight gain |
| The time to first clinical response | The time to first clinical response after treatment, up to 12 weeks after treatment | The time to first clinical response |
Countries
China
Contacts
CONTACTFang Luo
PRINCIPAL_INVESTIGATORFang Luo
Beijing Tiantan Hospital
Outcome results
None listed