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NCT Number: NCT07635394

Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome

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

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Key information

Conditions

Irritable Bowel Syndrome (IBS) Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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).

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.

Primary outcomes

  1. The IBS Severity Scoring System (IBS-SSS) and respnse rate

    Time frame: Up to 12 weeks after treatment

    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).

Secondary outcomes

  1. The IBS Quality of Life (IBS-QOL) questionnaire

    Time frame: Up to 12 weeks after treatment

    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.

  2. The Bristol Stool Form (BSF) scale

    Time frame: Up to 12 weeks after treatment

    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).

  3. The Hospital Anxiety and Depression Scale (HADS)

    Time frame: Up to 12 weeks after treatment

    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.

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

    Time frame: Up to 12 weeks after treatment

    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.

  5. The adverse events

    Time frame: Up to 12 weeks after treatment

    The occurrence of the dizziness, somnolence, peripheral edema, dry mouth and weight gain

  6. The time to first clinical response

    Time frame: The time to first clinical response after treatment, up to 12 weeks after treatment

    The time to first clinical response

Study contacts

Contact information is provided by the study sponsor or research team.

Fang Luo

CONTACT

[email protected]

+86 13611326978

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Beijing Jianjia Rehabilitation Hospital
  • Hebei Medical University Third Hospital
  • Hengshui People's Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Jun 9, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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