Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

ConditionIrritable Bowel Syndrome (IBS)

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

SponsorBeijing Tiantan Hospital

About this trial

To explore the efficacy of pregabalin for patients with irritable bowel syndrome (IBS).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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.

Treatment groups

258 Participants

are divided into 2 treatment groups

Group A: The pregabalin groupExperimental treatment 2 interventions

Group B: The control groupOther 1 intervention

Trial 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