Palmitoleic Acid Combined With Infliximab for Promoting Intestinal Mucosal Healing in Crohn's Disease

Официальное название

A Randomized, Controlled Trial Investigating the Efficacy of Palmitoleic Acid Combined With Infliximab in Promoting Intestinal Mucosal Healing in Patients With Crohn's Disease

Обзор

This study aims to evaluate whether the combination of palmitoleic acid with infliximab can improve intestinal mucosal healing in patients with Crohn's disease compared with infliximab alone.

Подробное описание

This is a prospective, randomized, controlled, open-label clinical study designed to evaluate the efficacy of palmitoleic acid combined with infliximab in patients with Crohn's disease.

Eligible patients will be randomly assigned to receive either intravenous infliximab at standard clinical doses plus daily oral palmitic acid supplementation, or intravenous infliximab alone. The primary endpoint is complete mucosal healing at Week 26. Secondary endpoints include endoscopic remission, endoscopic response, clinical remission and clinical response at Week 26.

Вмешательства

• Препарат Palmitoleic Acid + Infliximab
  Patients will be administered oral palmitoleic acid at a dose of 720 mg once daily for 26 consecutive weeks, starting at Week 0. Concurrent infliximab will be administered intravenously at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.
• Препарат Infliximab
  Patients will receive infliximab alone administered intravenously at the standard dose of 5 mg/kg at Weeks 0, 2, and 6, followed by every 8 weeks thereafter.

Первичные конечные точки

• Complete mucosal healing [Срок оценки: From enrollment to the end of treatment at 26 weeks]

Вторичные конечные точки (4)

• Endoscopic remission [Срок оценки: From enrollment to the end of treatment at 26 weeks]
• Endoscopic response [Срок оценки: From enrollment to the end of treatment at 26 weeks]
• Clinical remission [Срок оценки: From enrollment to the end of treatment at 26 weeks]
• Clinical response [Срок оценки: From enrollment to the end of treatment at 26 weeks]

Критерии участия

Критерии включения

• Adult patients aged 18 to 75 years.
• Established diagnosis of Crohn's disease confirmed by radiologic, histologic, or endoscopic evidence.
• Active Crohn's disease at screening, defined as a Crohn's Disease Activity Index (CDAI) score between 220 and 450 (inclusive).
• Adequate cardiac, renal, and hepatic function, as assessed by the investigator based on screening laboratory tests, physical examination, and medical history, without findings that would pose an undue risk for study participation.
• Willingness and ability to provide written informed consent.
• Agreement to undergo all scheduled study procedures, including up to 3 endoscopic evaluations.

Критерии исключения

• Use of any biologic therapy (e.g., infliximab, adalimumab, ustekinumab, vedolizumab) within 8 weeks prior to screening.
• Use of supplements containing fish oil or other lipid supplements (e.g., macadamia oil, krill oil, flaxseed, primrose oil, sea buckthorn oil) within 8 weeks prior to screening.
• History of any intestinal resection or other Crohn's disease-related surgery.
• History of or active chronic or recurrent infectious disease.
• History of or current malignancy.
• Pregnancy, lactation, or intention to become pregnant during the study period.
• Known hypersensitivity to infliximab or palmitoleic acid preparations.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07417696 · POA-IFX-CD-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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