Effect Of Probiotics Supplementation on Outcome Of Malnourished Children

Not yet recruiting

• Conditions: Malnourished Children

• Registration Number: NCT06606951
• Lead Sponsor: Assiut University

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 \< 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

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-23
• Last Update Posted: 2024-09-23
• Study Start: 2025-01-01
• Primary Completion: 2025-11-30
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

Exclusion Criteria

• age below 6 month and above 5 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim of the study	Baseline	The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium)
perinatal history	Baseline	1. full term or preterm; 2. type of delivery; 3. NICU admission
Present history	Baseline	1. disease type; 2. onset; 3. course; 4. duration; 5. stool \&urine characters.
Feeding history	Baseline	1. breast feeding; 2. suckling power; 3. formula feeding
Maternal history	Baseline	1. The history of pregnancy and delivery; 2. Any maternal complications or illness during the pregnancy; 3. Usage of any drugs
Investigations	Baseline	1. complete blood count; 2. liver function test; 3. kidney function test; 4. Random blood glucose
Sample size	Baseline	102 patients