Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

Beijing Tiantan Hospital258 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

258

Conditions

Irritable Bowel Syndrome (IBS)

Interventions

The pregabalin groupDRUG

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).

Routine TreatmentDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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).

Locations (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: Up to 12 weeks after treatment

Secondary Outcomes

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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Central Contacts

Fang Luo

CONTACT

+86 13611326978 13611326978@163.com

Data from ClinicalTrials.gov

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