An Evaluation of the Tolerance, Compliance, Acceptability and Safety of a New Oral Nutritional Supplement in Dysphagic Patients
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Gastrointestinal Tolerance
研究概览
简要总结
This study will evaluate the gastrointestinal (GI) tolerance, compliance , acceptability and safety of a ready-to-use oral nutritional supplement drink for patients with dysphagia.
详细描述
Dysphagia is a complex condition common in a number of diagnoses including stroke, Parkinson's disease, head and neck cancer, dementia, learning disabilities and gastric/oesophageal motility disorders.
A modified textured diet and/or fluid is considered as an effective intervention in management of dysphagia. The International Dysphagia Diet Standardisation Initiative (IDDSI) have developed a new framework around the terms and descriptors used in the management of individuals with dysphagia. Malnutrition is very common in patients with dysphagia and the use of pre-thickened oral nutritional supplements (ONS) has been found as an effective way to manage this. However, due to impairment in the swallow process, dysphagic patients require pre-thickened oral nutritional supplement to ensure safe consumption of these nutritional supplements.
40 participants, requiring a new pre-thickened oral nutritional supplement in line with the new IDDSI framework recruited from hospitals, outpatients clinics, care homes, community hospitals, community dietetic/speech and language therapy services or stroke rehabilitation units will receive the ready-to-use oral nutritional supplement for a 4 week intervention period. This study aims to primarily evaluate gastro-intestinal tolerance, with secondary outcomes including compliance, acceptability, nutrient intake, anthropometry and safety.
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
- •Male or female
- •Age ≥ 18 years
- •Patients with a requirement for ≥ 250kcal/day from a milkshake style ONS for ≥ 4 weeks or current users of ONS
- •Patients identified to require mildly thick (IDDSI level 2) fluids.
- •Patients competent to provide written informed consent and able to answer questions
- •Patients able to take study ONS orally
排除标准
- •Patients that lack capacity to provide informed consent
- •Patients that are unable to take study ONS orally
- •Participants with chronic renal disease requiring dialysis
- •Participants with liver failure
- •Participants that are pregnant or lactating
- •Participation in other studies that may interfere with this study
- •Participants receiving 100% total nutritional requirements from tube feeding or parenteral nutrition
- •Patients with galactosaemia or lactose intolerance
- •Patients receiving palliative or end of life care
研究组 & 干预措施
IDDSI nutritional supplement drink
Single arm designed, 28day on IDDSI nutritional supplement drink
干预措施: IDDSI nutritional supplement drink (Dietary Supplement)
结局指标
主要结局
Gastrointestinal Tolerance
时间窗: Day 1, Day 2, Day 3, Day 10, Day 17, Day 24 and Day 31
Gastro-intestinal tolerance will be assessed daily throughout a 3 day baseline period before starting the study ONS and at the end of each week (day 10, day 17, day 24, day 31) using a standardised GI tolerance questionnaire including questions on number of bowel movements per day, other gastrointestinal symptoms such as flatulence, bloating, burping and abdominal discomfort. Patient-reported gastrointestinal symptoms with scale range for each symptom as s scale range minimum = none, maximum = severe. Change of symptom from baseline scale minimum = no change, maximum = worse.
次要结局
- Nutrient intake(Day 1, Day 17 and Day 31)
- Acceptability: Brief tick-box questionnaire(Day 1, Day 17, Day 31)
- Compliance(Once during baseline period (Day 1) and then daily through intervention period (Days 4-31))
- Anthropometry(Day 1 and Day 31)
- Safety (Adverse events reporting)(31 days.)