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Recruiting NCT07635394

Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

No phase Interventional Irritable Bowel Syndrome (IBS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The pregabalin group, Routine Treatment.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome (IBS). Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Efficacy and Safety of Pregabalin in Patients With Irritable Bowel Syndrome : A Multi-center Prospective Randomized Open Blinded End-point Trial

Overview

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

  • Drug 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).
  • Drug Routine 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.

Primary outcome measures

  • The IBS Severity Scoring System (IBS-SSS) and respnse rate [Time frame: Up to 12 weeks after treatment]
Secondary outcome measures (6)
  • The IBS Quality of Life (IBS-QOL) questionnaire [Time frame: Up to 12 weeks after treatment]
  • The Bristol Stool Form (BSF) scale [Time frame: Up to 12 weeks after treatment]
  • The Hospital Anxiety and Depression Scale (HADS) [Time frame: Up to 12 weeks after treatment]
  • The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score [Time frame: Up to 12 weeks after treatment]
  • The adverse events [Time frame: Up to 12 weeks after treatment]
  • The time to first clinical response [Time frame: The time to first clinical response after treatment, up to 12 weeks after treatment]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Tiantan Hospital — Beijing

Identifiers

NCT: NCT07635394 · KY2026-029-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗