A Randomized, Double Blind, Placebo Controlled Study Of Bacillus Coagulans Gbi 30, 6086 And Digestive Enzymes For The Treatment Of Loss Of Appetite In Hospitalized Individuals
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Self-evaluation of appetite by using the simplified nutrition assessment questionnaire (SNAQ) score.
研究概览
简要总结
Impaired appetite is a common feature of the illness. 10% to 40% of adult patients admitted to hospital exhibit some level of nutritional depletion, with much weight loss, occurring over the period of hospitalization. Nutritional supplements are used in most hospitals. Impaired appetite is a common feature of the illness. 10% to 40% of adult patients admitted to hospital exhibit some level of nutritional depletion, with much weight loss, occurring over the period of hospitalization. Nutritional supplements are used in most hospitals. The mechanism of poor nutritional intake in hospitalized patients is mostly attributed to gastric myoneural inhibition and gastrointestinal hypomotility with delayed gastric emptying. Peptide hormones released from the gut, such as ghrelin and peptide YY (PYY), which stimulate and inhibit the appetite, respectively. Ghrelin is produced by the stomach and its level is highest in the fasting state, rising sharply before, and falling within one hour of, a meal. Peptide YY is a naturally occurring peptide that is released into the circulation by intestinal L-cells following food ingestion. PYY3–36 is the major form of metabolically active PYY in both the gut mucosal endocrine cells and the circulation.
Digestive Probiotic: Bacillus Coagulans GBI-30, 6086 is a gram-positive, spore-forming, lactic acid producing bacteria. Because of the spore-forming qualities of GanedenBC30**,** the bacteria remain dormant at low pH and bile salts of the gastric transit and a 3-year shelf life. Once it reaches the intestines where the environment is favorable with moisture, food source, and temperature conditions, it comes out of its dormant state and germinates. Spores of B. Coagulans are excreted slowly via the feces for approximately 7 days after discontinuation of administration and provides the long-term effect in maintaining the normal gut health.
Combining a digestive probiotic with digestive enzymes will offer better relief from indigestion symptoms, both
in short and long-term and improve the appetite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •A SNAQ score greater or equal to 2 2)BMI less than or equal to 19 kg/m2 3)Patient consent.
排除标准
- •1.Clinically significant eating disorder 2.Overweight with BMI greater or equal to 25 kg/m2 3.Diabetes mellitus 4.Laboratory parameters outside the normal range that are associated with a clinically significant cardiovascular, pulmonologic, hematologic, hepatological, metabolic, or renal disease or that interfere with interpretation of the clinical study or that require medications that are not permitted in the study protocol 5.Elevation of the serum transaminase levels (ALT/AST) to more than 3-times of the upper normal value 6.Elevation of the bilirubin and gamma-glutamyl transferase levels (GGT) to beyond the maximum normal value.
结局指标
主要结局
1.Self-evaluation of appetite by using the simplified nutrition assessment questionnaire (SNAQ) score.
时间窗: 10 days
2.Improvement in the SNAQ score at final follow up as compare to baseline.
时间窗: 10 days
次要结局
- 1.Number and severity of adverse events (AE) and severe adverse events (SAE)(2.Median daily oral food intake in [kcal] which will be determined retrospectively and anamnestically by composing a dietary protocol and by conducting a standardized interview.)