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临床试验/NCT06606951
NCT06606951尚未招募不适用

Effect Of Probiotics Supplementation on Outcome Of Malnourished Children Admitted at Assiut University Children's Hospital

Assiut University0 个研究点目标入组 102 人开始时间: 2025年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
102
主要终点
Aim of the study

研究概览

简要总结

The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium

详细描述

Acute malnutrition is an imbalance between nutrient requirement and intake, resulting in cumulative deficits of energy, protein, or micronutrients that may negatively affect growth, development, and other relevant outcomes.

Primary acute malnutrition in children is the result of inadequate food supply caused by socioeconomic, and environmental factors, and it is most commonly seen in low- and middle-income countries.

Responsible factors include household food insecurity, poverty, poor nutrition of pregnant women, intrauterine growth restriction, low birth weight, poor breastfeeding and inadequate complementary feeding, frequent infectious illnesses, poor quality of water, hygiene, etc. Therefore, primary acute malnutrition is mostly social rather than biomedical in origin, but it is also multifactorial. The repetitive exposure to pathogens in the environment causes small intestinal bacterial colonization, with accumulation of inflammatory cells in the small intestinal mucosa, damage of intestinal villi, and, consequently, malabsorption of nutrients, which results in malnutrition.

Secondary acute malnutrition is usually due to abnormal nutrient loss, increased energy expenditure, or decreased food intake, frequently in the context of underlying, mostly chronic, diseases like cystic fibrosis, chronic renal failure, chronic liver diseases, childhood malignancies, congenital heart disease, and neuromuscular diseases Acute malnutrition is responsible for almost one third of all deaths in children < 5 years of age and causes intellectual or cognitive impairment among those who survive. he estimated number of underweight children (weight-for-age Z score < -2) globally is 101 million or 16%. In studies using various methods of assessing malnutrition, the prevalence of acute malnutrition among hospitalized children in developed countries ranged from 6 to 51% .

The human gastrointestinal tract harbours microbial populations consisting of 1013-1014 cells . The colonic bacteria are mainly anaerobic and carry out a range of metabolic processes, some of which are considered of benefit to the host. For example, gut microbes ferment indigestible carbohydrates, generating short-chain fatty acids (SCFAs) for the host. These SCFAs have been reported to have several health benefits to the host, including the provision of energy for epithelial cells and lowering the pH of the intestinal lumen, thus restricting growth of some pathogens and providing an anti-inflammatory effect to the host. The gut microbiota has also been observed to play an important role in absorption, storage and expenditure of energy from the diet as well as synthesis of vitamins K and B12 recent studies suggest a link between gut microbiota (GM) and malnutrition with several studies reporting predominance of pathogenic intestinal bacteria in the guts of malnourished children compared to healthy controls. Concordantly, it has been suggested that pathogenic overload leads to persistent enteric inflammation, increased permeability and nutrient malabsorption Such benefits have led to a growing interest in the use of prebiotics, probiotics and other dietary modifications to modulate the gut microbiota to improve nutrition and health Probiotics are defined as "live microorganisms that, when administered in adequate amounts, confer a health benefit on the host For instance, the addition of probiotics to infant formula has been known to confer numerous benefits to the infant, including the improvement of gut health and immunity, countering the growth of harmful bacteria (pathogens) in the gut and enhancing overall host immune and health status

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 1- Age group of children from 6 month up to 5 years

排除标准

  • age below 6 month and above 5 years

结局指标

主要结局

Aim of the study

时间窗: Baseline

The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium)

perinatal history

时间窗: Baseline

1. full term or preterm 2. type of delivery 3. NICU admission

Present history

时间窗: Baseline

1. disease type 2. onset 3. course 4. duration 5. stool \&urine characters.

Feeding history

时间窗: Baseline

1. breast feeding 2. suckling power 3. formula feeding

Maternal history

时间窗: Baseline

1. The history of pregnancy and delivery 2. Any maternal complications or illness during the pregnancy 3. Usage of any drugs

Investigations

时间窗: Baseline

1. complete blood count 2. liver function test 3. kidney function test 4. Random blood glucose

Sample size

时间窗: Baseline

102 patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayat Gamal Darwish

71515,Assuit

Assiut University

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