Madrid - Tolerance and Acceptability Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- GI side effects when using AYMES MADRID
研究概览
简要总结
Tolerance and Acceptability of a gum based thickener.
详细描述
To evaluate the tolerance and acceptability of AYMES MADRID, in patients that may require modified consistency fluids. Measuring GI tolerance, compliance, convenience and preference.
To obtain data to support an ACBS submissions for AYMES MADRID (to allow for prescription in the community at NHS expense).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult patients (≥18 years) who are able to communicate clearly.
- •Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by -Speech and Language Therapist.
- •Patients expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
- •Informed consent obtained from patient or for those without capacity following consultation with carers.
排除标准
- •Patients with maize / corn allergy requiring a maize free diet
- •Patients with inherited metabolic conditions.
- •Patients requiring enteral tube feeding or parenteral nutrition.
- •Patients with medical or dietary contraindication to any feed ingredients
- •Patients with delayed oral phase of swallowing.
- •Patients with significant renal (requiring dialysis) or hepatic impairment (e.g. hepatitis)
- •Patients with dysphagia not requiring stage 1, 2 or 3 thickened fluids.
- •Patients with uncontrolled inflammatory bowel disease or previous bowel resection with ongoing gastrointestinal symptoms.
- •Patients for whom the investigator has concerns regarding the ability or willingness of the patient and or carer to comply with protocol requirements
- •Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study (to prevent over burdening of participants and ensure a period of normalisation between study involvement)
研究组 & 干预措施
Experimental
Patients with dysphagia requiring Stage 1, 2 or 3 thickened fluids as determined by Speech and Language Therapist and who are expected to require provision of Stage 1, 2 or 3 thickened fluids for at least 2 further weeks.
干预措施: AYMES MADRID (Other)
结局指标
主要结局
GI side effects when using AYMES MADRID
时间窗: 9 Days
Recording of absence/presence of any nausea, vomiting, abdominal pain, bloating / flatulence, when using AYMES MADRID as assessed by presence / absence of side effect compared to baseline period.
次要结局
- Compliance with prescription of AYMES MADRID(9)
- Bowel habits of subjects when using AYMES MADRID - frequency(9 days)
- Bowel habits of subjects when using AYMES MADRID - stool consistency(9 days)