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临床试验/NCT05088408
NCT05088408已完成不适用

Comparative Study Between Colonoscopy Bowel Preparation With Clear Liquids, With and Without Two Servings of High Energy Nutritional Supplement

Clínica de Gastroenterologia2 个研究点 分布在 1 个国家目标入组 299 人开始时间: 2020年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
299
试验地点
2
主要终点
Mucosa visualization quality (Boston Bowel Preparation Scale)

研究概览

简要总结

The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions, yet it has been used off-label to alleviate the effects of hunger during bowel preparation for colonoscopy. Its impact in mucosa visualization quality and hunger alleviation is unknown. The product is liquid and nutritious but it is not transparent, thus it is conceivable that it could alleviate the discomfort of hunger during the preparation but possibly compromising mucosa visualization. In this study, participants who will undergo a colonoscopy (requested for an explicit medical indication) will take two bottles of the nutritional supplement during the usual bowel preparation. The quality of mucosal visualization and the participants opinion regarding satiety and product tolerance during bowel preparation will then be analysed.

详细描述

The high energy nutritional supplement Resource® Energy is approved for human nutritional support in various clinical conditions. However, it has been recommended by pharmacists to reduce hunger during bowel preparation for colonoscopy, without any medical prescription or recommendation as there is no scientific evidence regarding this use. Its impact in the quality of mucosal visualization during colonoscopy and in relieving hunger is unknown, thus requiring research.

The dietary supplement is liquid and nutritious, each serving consisting of 200 mL containing carbohydrates 42 g, lipids 10 g, proteins 11.2 g and fiber < 1 g, totalling 303 kcal. It is thus conceivable that it can mitigate the discomfortable feeling of hunger during bowel preparation, but because it is not transparent it could possibly hamper mucosa visualization.

One hundred and fifty control patients (with clinical indication for undergoing colonoscopy) will undergo bowel preparation as usual with the standard of care polyethylene glycol 3350 in 4 litres of water (Klean-Prep®): one day before the colonoscopy with no ingestion of solid foods, possibly with ingestion of clear liquids with or without sugar (such as tea or other transparent beverages without pulp, but not milk, yogurt, broth or gelatine), and with ingestion of 275,84 g (4 sachets) of polyethylene glycol 3350 in 4 litres of water in 3 to 4 hours (250 mL every 15 minutes), starting at 18:00; in the day of the exam the patients can drink the same clear liquids with or without sugar until 4 hours before the colonoscopy, which will be carried out in the morning.

One hundred and fifty patients (with clinical indication for undergoing colonoscopy) will undergo bowel preparation as usual and take two servings of Resource® Energy Apricot.

All patients will be asked about feelings of hunger or side effects of bowel preparation and colonoscopy (nausea, vomits, abdominal pain, abdominal discomfort, abdominal pressure, abdominal bloating, syncope, blood in stool, sleep disturbance, work absenteeism) in a scale from 0 to 10, before and after the colonoscopy. This scale is often used to assess appetite.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • individual requesting a non-contraindicated colonoscopy (with clinical indication) at the outpatient clinic.

排除标准

  • pregnancy
  • Allergy to any ingredient of Resource® Energy Apricot

结局指标

主要结局

Mucosa visualization quality (Boston Bowel Preparation Scale)

时间窗: During the procedure

Mucosa visualization quality assessed using the Boston Bowel Preparation Scale (0 to 9, 0 being the worst)

次要结局

  • Adenoma detection rate(During the procedure)
  • Amount of rinsing needed(During the procedure)
  • Hunger during bowel preparation(Reported in the day of the procedure)

研究者

发起方
Clínica de Gastroenterologia
申办方类型
Other
责任方
Sponsor

研究点 (2)

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