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Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID07635394

Evaluating the Effectiveness of Pregabalin Compared to Routine Treatment for Adults with Irritable Bowel Syndrome Aged 18 to 70

Led by Beijing Tiantan Hospital · Updated on 2026-06-25

258

Participants Needed

1

Research Sites

155 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how effective pregabalin is for treating adults with irritable bowel syndrome IBS. This study also aims to explore the causes of IBS and identify treatments that work quickly and effectively for these causes. The trial focuses on adults aged 18 to 70 who have mild to moderate IBS confirmed by specific diagnostic criteria. Participants are assigned to one of two groups. The pregabalin group receives a carefully scheduled dose that starts at 75 mg twice daily and increases to 225 mg twice daily by week 10, followed by a tapering period at week 12. Both groups receive routine care from gastroenterologists, which may include medications like loperamide to manage stool frequency, rifaximin or eluxadoline for specific cases, and antispasmodics for cramping. The control group receives only this routine care without pregabalin. During the study, participants will be monitored up to 12 weeks after treatment starts. Researchers will assess IBS severity using a scoring system and track response rates. They will also evaluate quality of life, stool form, anxiety and depression levels, somatic symptoms, adverse events, and the time it takes to see clinical improvement. This comprehensive monitoring helps understand the treatments effects and safety over the study period.

CONDITIONS

Brief Title

Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

Research Team

F

Fang Luo

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