Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome
23 de junio de 2026 actualizado por: Fang Luo, Beijing Tiantan Hospital
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).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
258
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Fang Luo
- Número de teléfono: +86 13611326978
- Correo electrónico: 13611326978@163.com
Ubicaciones de estudio
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Porcelana, 100050
- Reclutamiento
- Beijing Tiantan Hospital
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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).
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
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. 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.
|
|
Otro: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The IBS Severity Scoring System (IBS-SSS) and respnse rate
Periodo de tiempo: 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).
|
Up to 12 weeks after treatment
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The IBS Quality of Life (IBS-QOL) questionnaire
Periodo de tiempo: 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.
|
Up to 12 weeks after treatment
|
|
The Bristol Stool Form (BSF) scale
Periodo de tiempo: 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).
|
Up to 12 weeks after treatment
|
|
The Hospital Anxiety and Depression Scale (HADS)
Periodo de tiempo: 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.
|
Up to 12 weeks after treatment
|
|
The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score
Periodo de tiempo: 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.
|
Up to 12 weeks after treatment
|
|
The adverse events
Periodo de tiempo: Up to 12 weeks after treatment
|
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
Periodo de tiempo: The time to first clinical response after treatment, up to 12 weeks after treatment
|
The time to first clinical response
|
The time to first clinical response after treatment, up to 12 weeks after treatment
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fang Luo, Beijing Tiantan Hospital
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
7 de abril de 2026
Finalización primaria (Actual)
8 de abril de 2026
Finalización del estudio (Estimado)
31 de marzo de 2029
Fechas de registro del estudio
Enviado por primera vez
17 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de junio de 2026
Publicado por primera vez (Actual)
9 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
25 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de junio de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KY2026-029-02
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
This requires permission from the corresponding author
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .