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临床试验/NCT04143633
NCT04143633Unknown不适用

Low FODMAP Diet Chronic Effect on Nutritional Status, Disease Activity and Gut Microbiota in Patients With IBS and UC

Hospital General de Mexico2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2018年2月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
105
试验地点
2
主要终点
Nutritional status

研究概览

简要总结

Gastrointestinal disorders represents 20-50% of referrals to the gastroenterologist; being the most affected womens, youths and older adults. Among these alterations are the Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC), which affects the gut causing impaired motility. The pharmacological and nutritional treatment are modified according to the symptomatology and activity of each patients. Currently the implementation of low FODMAP diets for 6 to 8 weeks in patients whith IBS improves symptoms such as bloating, flatulence and abdominal pain. However due to the number of restricted foods a long term attachment could limited the nutritional content, consequently affecting the nutritional status, gut microbiota an quality of life. A low FODMAP diet are useful to improve gastrointestinal symptoms in patients with UC and causes changes in nutritional status.

详细描述

Irritable Bowel Syndrome (IBS) and Ulcerative Colitis (UC) affect principally the gut, causing symptoms that alter intestinal motility, with a multifactorial etiology. The pharmacological and nutritional treatment varies according to the symptoms and activity of each patient. The most commonly used are the standard diet (SD), which excludes foods known as irritants or inflammatory. On the other hand, are the low fodmap diet (LFD) (fermentable oligosaccharides. disaccharides, monosaccharides and polyols), these highly fermentable carbohydrates can pass unabsorbed to the colon and induce the gas production due to the fermentation of gut microbiota and cause symptoms such as: bloating, flatulence, abdominal pain and altered bowel habit. It consists in two stages: first the restriction of all foods that contain fodmaps and second the re exposure in which indicate the introduction of each food restricted before to evaluate the tolerance, for 6 to 8 weeks. Some studies show that the low fodmap diet improve the symptoms in both groups, however because of the restriction and the limited content of foods, they have had risk to present nutritional deficiencies. The aim of the present is to evaluate the effect of a low fodmap diet for 10 weeks on gastrointestinal symptoms, nutritional status and microbiota in patients with IBS and UC.

Methods: a controlled, blinded clinical trial will be conducted in patients who assist to medical monitoring in gastroenterology service with diagnosis of IBS or UC. The sample size was determined with a 0.5 effect size, an alpha error 0.05 and power of 80%, which determined 64 patients for each group (total: 128). After singing the informed consent, will be determined their total energy expenditure (TEE) and consecutively will be assigned an ID previously randomized to SD (<16 g of fodmaps) or LFD (<10 g of fodmaps), with a distribution of 55% carbohydrates, 20% proteins and 25% lipids. During the 10 weeks will be three follow-ups, first the basal, intermediate (week 5) and final (10 weeks after), will be performed body composition (RJL Quantum III), anthropometry (waist, hip, arm and chest circumference), gastrointestinal symptoms (ROMA III and Mayo Scale), quality of life (WHOQL-BREF), food frequency and 24-hour reminder and blood chemistry (anemia, hypoalbuminemia, vitamin D, calcium, potassium, c reactive protein, VSG, etc), all of them basal and final.

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
Single (Participant)

盲法说明

The patient doesn´t know the type of diet (standard or low FODMAP)

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Irritable Bowel Syndrome confirmed by Rome criteria III
  • Ulcerative Colitis confirmed by Mayo Scale
  • Informed Consent signed
  • BMI between 18.5 and 29.9 kg/m2
  • Males and females
  • Age between 18-59 years
  • Mexican patients

排除标准

  • Chron´s disease diagnosed
  • Treatment whith antibiotis during the last two weeks
  • Bowel resection
  • Short bowel syndrome
  • Treatment wihth probiotics or enzimes (A-galactosidase)
  • Pregnancy
  • Nutritional deficiencies or anemia
  • Patients whith diet supplements

结局指标

主要结局

Nutritional status

时间窗: The patients will be evaluated at weeks 1 and 10

Changes from baseline of nutrtitional status measured with cholesterol (mg/dl), triglycerides (mg/dl), albumin (mg/dl), calcium (mg/dl), iron (mg/dl), vitamin B12 (mg/dl), vitamin D (mg/dl), hemoglobin (mg/dl), hematocrit (mg/dl), creatinin (mg/dl) on blood

次要结局

  • Quality of life in patients with Irritable Bowel Syndrome and Inflammatory Bowel Disease(The patients will be evaluated at weeks 1, 5 and 10)
  • Irritable Bowel Syndrome Severity Score(Participants will be evaluated at weeks 1, 5 and 10)
  • Blood chemistry(Participants will be evaluated at weeks 1 and 10)
  • Gastrointestinal Symptoms Severity(Participants will be evaluated at weeks 1, 5 and 10)
  • Anthropometric measurements(Participants will be evaluated at weeks 1, 5 and 10)
  • Adherence to treatment(The patients will be evaluated at weeks 1, 5 and 10)
  • Body composition analysis(The patients will be evaluated at weeks 1, 5 and 10)
  • Gut microbiota with a low FODMAP diet(Participants will be evaluated at weeks 1, 5 and 10)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Nallely Bueno Hernández

Investigator In Medical Science B

Hospital General de Mexico

研究点 (2)

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