Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

NCT07635394 | Recruiting

• 1 other identifier: KY2026-029-02
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Irritable Bowel Syndrome (IBS)

Keywords

Irritable Bowel Syndrome; pregabalin

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 12 weeks after treatment

Secondary Outcomes (6)

• The IBS Quality of Life (IBS-QOL) questionnaire

  Up to 12 weeks after treatment

• The Bristol Stool Form (BSF) scale

  Up to 12 weeks after treatment

• The Hospital Anxiety and Depression Scale (HADS)

  Up to 12 weeks after treatment

• The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score

  Up to 12 weeks after treatment

• The adverse events

  Up to 12 weeks after treatment

Study Arms (2)

The pregabalin group

EXPERIMENTAL

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). Patients also received routine treatment from gastroenterologists. 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.

Drug: The pregabalin group; Drug: Routine Treatment

The control group

OTHER

The control group only received routine treatment from gastroenterologists. 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.

Drug: Routine Treatment

Interventions

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.

The control group; The pregabalin group

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).

The pregabalin group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• Hengshui People's Hospital: collaborator
• Hebei Medical University Third Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Fang Luo

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Luo

CONTACT

+86 13611326978; 13611326978@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The statisticians performing the final data analysis
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day surgery and Pain Management

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: May 17, 2026
• First Posted: June 9, 2026
• Study Start: April 7, 2026
• Primary Completion: April 8, 2026
• Study Completion (Estimated): March 31, 2029
• Last Updated: June 9, 2026

Record last verified: 2026-04

Locations

CN (1)