An Open-label Clinical Study to evaluate the safety and gastrointestinal tolerance (Product Compliance) of Maxvida High Protein in adults requiring isocaloric formula for enteral tube feeding.
概览
- 阶段
- Post Marketing Surveillance
- 状态
- 尚未招募
- 发起方
- Signtura Health and nutrition
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. To study Continuous GI tolerance (Product Compliance):
概览
简要总结
| This is an Open-label | ||
| Clinical Study to evaluate the safety and gastrointestinal tolerance (Product | ||
| Compliance) of Maxvida High Protein in adults requiring isocaloric formula | ||
| for enteral tube feeding, Maxvida High Protein is manufactured by Signutra Inc. |
Primary objectives are
-
To study Continuous GI tolerance (Product Compliance):
-
Diarrhea free day
-
Stomach irritation
-
Regurgitation
-
Abdominal bloating
-
Vomiting
-
GRV less than 500 ml.
Secondary objectives are
- To Evaluate Change in weight (kg) during pre and post intervention of the study product
- To Evaluate Change in serum albumin during pre and post intervention of the study product
- Adverse event and serious adverse event monitoring based on clinical and laboratory AE’s
Total 30 Patients will be enrolled as per inclusion criteria and duration of study will be 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
入选标准
- •1.Ready to Sign informed consent form or informed consent form signed by legally acceptable representatives.
- •2.Aged more than 18 years 3.Gender: Male & Female.
- •4.Hospitalized patients requiring isocaloric formula for enteral feeding.
- •5.Can tolerate enteral tube feeding.
- •6.Estimated duration of Hospital stays equal to or greater than 2 days.
排除标准
- •1.Receiving tube feeding prior to hospitalization.
- •2.Patients less than 18 years of age.
- •3.Patients having allergy to constituents of Maxvida High Protein.
- •4.Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
结局指标
主要结局
1. To study Continuous GI tolerance (Product Compliance):
时间窗: end of hospitalization or 5 days whichever earlier.
a. Diarrhea free day
时间窗: end of hospitalization or 5 days whichever earlier.
b. Stomach irritation
时间窗: end of hospitalization or 5 days whichever earlier.
c. Regurgitation
时间窗: end of hospitalization or 5 days whichever earlier.
d. Abdominal bloating
时间窗: end of hospitalization or 5 days whichever earlier.
e. Vomiting
时间窗: end of hospitalization or 5 days whichever earlier.
f. GRV less than 500 ml (GRV to be checked at 0730 hours, 0900 hours, 1530 hours, 1700 hours)
时间窗: end of hospitalization or 5 days whichever earlier.
次要结局
- 1.To Evaluate Change in weight (kg) during pre and post intervention of the study product(2.To Evaluate Change in serum albumin during pre and post intervention of the study product)
研究者
Dr Pankaj Kumta
KIMS Hospital Enterprises