Efficacy of Pregabalin for Patients With Irritable Bowel Syndrome
23 de junho de 2026 atualizado 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).
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
258
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Fang Luo
- Número de telefone: +86 13611326978
- E-mail: 13611326978@163.com
Locais de estudo
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100050
- Recrutamento
- Beijing Tiantan Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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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.
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Outro: 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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The IBS Severity Scoring System (IBS-SSS) and respnse rate
Prazo: Up to 12 weeks after treatment
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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).
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Up to 12 weeks after treatment
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The IBS Quality of Life (IBS-QOL) questionnaire
Prazo: Up to 12 weeks after treatment
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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.
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Up to 12 weeks after treatment
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The Bristol Stool Form (BSF) scale
Prazo: Up to 12 weeks after treatment
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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).
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Up to 12 weeks after treatment
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The Hospital Anxiety and Depression Scale (HADS)
Prazo: Up to 12 weeks after treatment
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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.
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Up to 12 weeks after treatment
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The Patient Health Questionnaire-12 Somatic Symptom (PHQ-12 SS) Score
Prazo: Up to 12 weeks after treatment
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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.
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Up to 12 weeks after treatment
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The adverse events
Prazo: Up to 12 weeks after treatment
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The occurrence of the dizziness, somnolence, peripheral edema, dry mouth and weight gain
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Up to 12 weeks after treatment
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The time to first clinical response
Prazo: The time to first clinical response after treatment, up to 12 weeks after treatment
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The time to first clinical response
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The time to first clinical response after treatment, up to 12 weeks after treatment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fang Luo, Beijing Tiantan Hospital
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de abril de 2026
Conclusão Primária (Real)
8 de abril de 2026
Conclusão do estudo (Estimado)
31 de março de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
17 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de junho de 2026
Primeira postagem (Real)
9 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de junho de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- KY2026-029-02
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano IPD
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