Reduction of Severity and Duration of Pediatric Gastroenteritis Through Amino Acid Fortified Oral Rehydration Therapy
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Daily Stool Frequency
研究概览
简要总结
The goal of this clinical trial is to compare amino acid-fortified oral rehydration therapy (ORT) to the standard of care ORT in pediatric patients with acute gastroenteritis (AGE). The main questions it aims to answer are:
- can amino acid-fortified ORT reduce the duration and severity of AGE compared to standard of care ORT?
- can amino acid-fortified ORT increase the secretion of antimicrobial peptides in the gastrointestinal tract compared to standard of care ORT?
Participants will be assigned to the experimental treatment (amino acid-fortified ORT) or the standard of care ORT and their disease severity, duration, and stool antimicrobial peptide content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the ages of 6 months and 5 years.
- •Experiencing mild to moderate acute gastroenteritis for less than two (2) days before admission to Pediatric Emergency Department.
- •Diarrhea presumed infectious
排除标准
- •Severe gastroenteritis with moderate to severe dehydration
- •Requiring inpatient care
- •Requiring antibiotics
- •Requiring IV rehydration
- •History of chronic diarrhea
- •Presenting with diarrhea for greater than 2 days prior to admission
- •Allergy to any of the ingredients in the study products
- •Inborn metabolic disorder of amino acids
- •Receives post-pyloric feedings
研究组 & 干预措施
Amino acid-fortified oral rehydration therapy
Participants will consume the amino acid-fortified oral rehydration therapy (fORT) according to the World Health Organization (WHO) Treatment Plan A for ORT administration:
- Child under 24 months: 50 to 100 ml ORT after each loose stool (approximately 500 ml daily)
- Child from 2 to 10 years: 100 to 200 ml ORT after each loose stool (approximately 1000 ml daily)
干预措施: Fortified Oral Rehydration Therapy (Drug)
Standard of care oral rehydration therapy
Participants will consume the standard of care oral rehydration therapy according to the WHO Treatment Plan A for ORT administration:
- Child under 24 months: 50 to 100 ml after each loose stool (approximately 500 ml daily)
- Child from 2 to 10 years: 100 to 200 ml after each loose stool (approximately 1000 ml daily)
干预措施: Standard of Care Oral Rehydration Therapy (Dietary Supplement)
结局指标
主要结局
Daily Stool Frequency
时间窗: Up to 14 days
Number of bowel movements (BMs) per day (count)
Daily Stool Mass
时间窗: Up to 14 days
Total mass of stool per day from measured BMs in grams
Duration of Diarrhea
时间窗: Up to 14 days
Duration of diarrhea in hours from onset until 3 formed stools in a row
次要结局
- Consumption of Study Intervention(Up to 14 days)
- Stool Human Beta-Defensin-2 Content(Up to 14 days)
- Body Weight(Up to 14 days)
- Stool Consistency(Up to 14 days)
研究者
Paul A Breslin
Professor of Nutritional Sciences
Rutgers, The State University of New Jersey