Pregabalin for irritable bowel syndrome in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates the potential benefit of pregabalin for adults aged 18 to 70 with irritable bowel syndrome. Participants are assigned to receive pregabalin in addition to routine treatment. The study aims to understand both the efficacy of pregabalin in IBS symptoms and potential underlying factors contributing to IBS, while monitoring safety and tolerability. It uses Rome IV criteria and IBS-SSS to identify eligible participants and excludes individuals with other GI conditions, significant comorbidities, or recent pregabalin exposure. Conducted at Beijing Tiantan Hospital with collaboration from several regional centers, recruitment is limited to sites in Beijing to support standardized assessment.

Why it matters

Who can join: the full rules

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).

Where it's running

• Beijing Tiantan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Fang Luo — Beijing Tiantan Hospital
• Study coordinator: Fang Luo
• Email: 13611326978@163.com
• Phone: +86 13611326978

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.