TOLER-ENT Study: A Study to Investigate the Tolerance of the High Energy, High Protein Formula Sondalis® HP 2 kcal
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Evaluation tolerance from baseline after 2 months: Total Score
研究概览
简要总结
A multicentre, prospective, open-label, single arm study for 2 months, involving adult patients under poorly tolerated Home Enteral Nutrition (HEN). The study aims to analyse the evolution of tolerance and quality of life of HEN patients after switching from a High Protein High Energy (HPHE) polymeric Enteral Nutrition (EN) formula with or without fibre to Sondalis® HP 2kcal, with or without fibre. Eligible patients will give their written consent to participate before being included into the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged ≥18 years,
- •Being under EN with polymeric HPHE product with or without fibre (=HPHE),
- •Stable caloric prescription during HEN for at least one month,
- •Patient with at least a score of 2 on at least 1 item of tolerance questionnaire,
- •Investigators' judgement to change to HPHE concentrated,
- •HEN is planned for ≥ 8 weeks,
- •Life expectancy ≥ 3 months.
- •Patient or his/her primary caregiver was required to be able to understand the study and to be fully free to participate in it,
- •Patient having signed an informed consent,
- •Patient registered with a social security scheme,
- •Patient willing to adhere to study procedures,
排除标准
- •Pregnancy or breastfeeding,
- •Being either under PN or ONS,
- •Acute intestinal disease such as gastric ulcer, gastritis, gastroparesis,
- •Patient under prokinetic agents during the study phase,
- •Patient receiving antibiotic, chemotherapy in the 7 days prior to inclusion,
- •Patient receiving radiation treatment except head and neck location,
- •Patient expected to receive chemotherapy or radiation treatment during the study except head and neck location ,
- •Severe infectious disease and/or fever > 38,5°C,
- •Emergent hospitalization within last month,
- •Known allergy or intolerance to any of the Sondalis® HP 2kcal with or without fibre ingredients,
- •Previous treatment with HPHE concentrated at home (2kcal),
- •Current participation in another intervention study or participation in a previous study for which exclusion period applies.
- •Non-compliance with prescription and administration modalities as suspected by investigator and/or by home care provider dietitian
结局指标
主要结局
Evaluation tolerance from baseline after 2 months: Total Score
时间窗: 60 days
The digestive tolerance of enteral nutrition is assessed using a patient reported outcomes (PRO) questionnaire designed by clinicians. The questionnaire is composed of 9 items corresponding to the most frequent symptoms: gastro-oesophageal reflux, nausea, vomiting, feeling of an overfull stomach, bloating, flatulence, stomach pain, constipation, diarrhea. Each item includes questions relating to the frequency and impact of the symptom on daily life.
次要结局
- Evaluation of Tolerance from baseline to one month and from one month to two months: Total Score(60 days)
- Evaluation of Tolerance at baseline,one and two months: for each Items(60 days)
- Evolution of observance: number of bags(30 days)
- Evolution of anthropometric measures: body weight evolution(60 days)
- Evolution of food intake(30 days)
- Evolution of observance: score(30 days)
- Evolution of Enteral Nutrition (EN) prescription procedure: Time(30 days)
- Evolution of Enteral Nutrition (EN) prescription procedure: Number of Bags(30 days)
- Evolution of quality of life(60 days)
- Evolution of anthropometric measures: handgrip test(60 days)
- Evolution of Enteral Nutrition (EN) prescription procedure: Volume(30 days)
- Evolution of Enteral Nutrition (EN) prescription procedure: Supplementary Hydration(30 days)
- Safety events reporting(60 days)