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Clinical Trials in China / NCT07635394
Recruiting Not applicable

Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

NCT07635394 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Tiantan Hospital
Phase
Not applicable
Started
2026-04-07
Last updated
2026-06-25

Condition(s) studied

Irritable Bowel Syndrome (IBS)

Investigational drug(s) / intervention(s)

The pregabalin groupRoutine Treatment →

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).

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing Beijing Municipality Recruiting

More Beijing Tiantan Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07635394 on ClinicalTrials.gov ↗ ← All trials in China