Effect of Palmitoleic Acid (FAn-7) on Expression of HNF4γ and Ulcerative Colitis (UC) Activity
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- clinical and endoscopic remission
研究概览
简要总结
Introduction: Inflammatory bowel disease (IBD) refers to two chronic diseases that cause intestinal inflammation, ulcerative colitis (UC) and Crohn's disease (CD). The conventional treatment is not effective; therefore, alternative therapies may be effective specially in UC patients. Fatty acid (FA) may have a beneficial effect on some UC patients. The increasing incidence and prevalence of UC and ineffective treatments in some patients, allows search coadjuvant therapies. Objective: Quantification of differences between patients with and without FA. Methods: In two groups of patients with UC is administered FA and placebo. We will measure the changes clinical, endoscopic and histological in both groups, before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histopathologically confirmed diagnosis of UC.
- •With mild and moderate disease.
- •Patients treated with only doses of 5-aminosalicylates (5-ASA)
- •BMI, 18 to 34.9 kg/m2
- •Born in Mexico the last two generations
- •Each patient will be asked to sign and date the consent form, to indicate that you agree to participate.
排除标准
- •Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
- •With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
- •If the patient use drugs that inhibit fat absorption.
- •Patients after partial or total resection of stomach or small intestine.
- •Steroid users.
- •Patients in remission histology, clinical and endoscopic.
- •Patients treated with FAn-3,6 or 9.
结局指标
主要结局
clinical and endoscopic remission
时间窗: 2 months
We will perfom a basal and final colonoscopy
次要结局
- quantification IL-6 in colonic mucosa(2 months)
研究者
Jesús Kazuo Yamamoto Furusho
MD PhD
National Institute of Medical Sciences and Nutrition, Salvador Zubiran