Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

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

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

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Drug: The pregabalin group; Drug: Routine Treatment

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.

• Study Type: Interventional
• Enrollment (Estimated): 258
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Luo; Phone Number: +86 13611326978; Email: 13611326978@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Recruiting
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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). 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; 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.
Other: The control group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The IBS Quality of Life (IBS-QOL) questionnaire	The IBS Quality of Life (IBS-QOL) questionnaire at baseline and at 4, 8, and 12 weeks, which consists of 8 subscales (dysphoria, activity interference, personal image, health concerns, food avoidance, social reaction, sexuality, social relationship), with a total of 34 questions. Each subscale score ranges from 0 to 100 points. A higher score indicates a better quality of life.	Up to 12 weeks after treatment
The Bristol Stool Form (BSF) scale	The Bristol Stool Form (BSF) scale at baseline and at 4, 8, and 12 weeks, which is used to record the difference in proportions of the patient's daily bowel habits (hard stools, normal stools, and loose stools).	Up to 12 weeks after treatment
The Hospital Anxiety and Depression Scale (HADS)	The Hospital Anxiety and Depression Scale (HADS) at baseline and at 4, 8, and 12 weeks, which consists of two sub-scales. Each sub-scale consists of 7 items and each item scored from 0 to 3. A higher score indicates more severe anxiety or depression. A score of 11 or above can indicate clinically significant anxiety or depression.	Up to 12 weeks after treatment
The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score	The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score at baseline and at 4, 8, and 12 weeks, which includes 12 extra-GI symptoms such as back pain, limb pain, and headache. A higher score indicates more severe somatization symptoms.	Up to 12 weeks after treatment
The adverse events	The occurrence of the dizziness, somnolence, peripheral edema, dry mouth and weight gain	Up to 12 weeks after treatment
The time to first clinical response	The time to first clinical response	The time to first clinical response after treatment, up to 12 weeks after treatment

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Hebei Medical University Third Hospital; Hengshui People's Hospital
• Investigators: Principal Investigator: Fang Luo, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Actual): April 8, 2026
• Study Completion (Estimated): March 31, 2029

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: June 7, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; pregabalin
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: KY2026-029-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: This requires permission from the corresponding author

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No