Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606951
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Effect Of Probiotics Supplementation on Outcome Of Malnourished Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect Of Probiotics Supplementation on Outcome Of Malnourished Children Admitted at Assiut University Childrens Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Outcome Of malnourished children who receive probiotics Lactobacillus and Bifidobacterium
Detailed Description:
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 lt 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 lt -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
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 lt 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 lt -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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None