Malnourished ChildrenNCT06606951
Effect Of Probiotics Supplementation on Outcome Of Malnourished Children
An observational study of Malnourished Children, run by Assiut University.
Trial summary
The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium Read more about this study
- Who is it for?
- Ages 5 months to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Malnourished Children
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jan 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 months to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium)
Who may be able to join
- 1- Age group of children from 6 month up to 5 years
Who cannot join
- age below 6 month and above 5 years
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect Of Probiotics Supplementation on Outcome Of Malnourished Children Admitted at Assiut University Children's Hospital
The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium
Read the 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
- Conditions
- Malnourished Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim of the study
The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium)
Measured: Baseline
perinatal history
- full term or preterm
- type of delivery
- NICU admission
Measured: Baseline
Present history
- disease type
- onset
- course
- duration
- stool \&urine characters.
Measured: Baseline
Feeding history
- breast feeding
- suckling power
- formula feeding
Measured: Baseline
Maternal history
- The history of pregnancy and delivery
- Any maternal complications or illness during the pregnancy
- Usage of any drugs
Measured: Baseline
Investigations
- complete blood count
- liver function test
- kidney function test
- Random blood glucose
Measured: Baseline
Sample size
102 patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Malnourished ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayat Gamal Darwish, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606951
- Sponsor's protocol ID
- Probiotics Supplementation
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016 Aug 19;14(8):e1002533. doi: 10.1371/journal.pbio.1002533. eCollection 2016 Aug.
PubMed 27541692Bakker GJ, Zhao J, Herrema H, Nieuwdorp M. Gut Microbiota and Energy Expenditure in Health and Obesity. J Clin Gastroenterol. 2015 Nov-Dec;49 Suppl 1:S13-9. doi: 10.1097/MCG.0000000000000363.
PubMed 26447957van den Elsen LW, Poyntz HC, Weyrich LS, Young W, Forbes-Blom EE. Embracing the gut microbiota: the new frontier for inflammatory and infectious diseases. Clin Transl Immunology. 2017 Jan 20;6(1):e125. doi: 10.1038/cti.2016.91. eCollection 2017 Jan.
PubMed 28197336
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Probiotics Supplementation on Outcome Of Malnourished Children Admitted at Assiut University Children's Hospital
- ClinicalTrials.gov ID
- NCT06606951
- Acronym / sponsor ID
- Probiotics Supplementation
- Conditions
- Malnourished Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 5 months to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium)
Key inclusion criteria (1 listed)
- 1- Age group of children from 6 month up to 5 years
Key exclusion criteria (1 listed)
- age below 6 month and above 5 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Aim of the study
Time frame: Baseline
The Outcome Of malnourished children who receive probiotics (Lactobacillus and Bifidobacterium)
perinatal history
Time frame: Baseline
1. full term or preterm 2. type of delivery 3. NICU admission
Present history
Time frame: Baseline
1. disease type 2. onset 3. course 4. duration 5. stool \&urine characters.
Feeding history
Time frame: Baseline
1. breast feeding 2. suckling power 3. formula feeding
Maternal history
Time frame: Baseline
1. The history of pregnancy and delivery 2. Any maternal complications or illness during the pregnancy 3. Usage of any drugs
Investigations
Time frame: Baseline
1. complete blood count 2. liver function test 3. kidney function test 4. Random blood glucose
Sample size
Time frame: Baseline
102 patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Background: PubMed 27541692Sender R, Fuchs S, Milo R. Revised Estimates for the Number of Human and Bacteria Cells in the Body. PLoS Biol. 2016 Aug 19;14(8):e1002533. doi: 10.1371/journal.pbio.1002533. eCollection 2016 Aug.
- Results publication: PubMed 26447957Bakker GJ, Zhao J, Herrema H, Nieuwdorp M. Gut Microbiota and Energy Expenditure in Health and Obesity. J Clin Gastroenterol. 2015 Nov-Dec;49 Suppl 1:S13-9. doi: 10.1097/MCG.0000000000000363.
- Results publication: PubMed 28197336van den Elsen LW, Poyntz HC, Weyrich LS, Young W, Forbes-Blom EE. Embracing the gut microbiota: the new frontier for inflammatory and infectious diseases. Clin Transl Immunology. 2017 Jan 20;6(1):e125. doi: 10.1038/cti.2016.91. eCollection 2017 Jan.
- Individual participant dataSharing planned: Undecided
Related trials for Malnourished Children
Active, not recruitingPhase 2
Maternal Probiotic Intervention to Improve Gut Health-Trial II-Pakistan
Environmental Enteric Dysfunction (EED), Stunting
Recruiting
Role of Vitamin D Supplementation in Children With Irritable Bowel Syndrome
Irritable Bowel Syndrome (IBS), Vitamin D Deficiency
Active, not recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
Active, not recruitingPhase 2
Comparative Efficacy of Antibiotics for Small Intestine Bacterial Overgrowth in Bangladeshi Children
Small Intestine Bacterial Overgrowth
Recruiting
Effectiveness of an Alternative Protocol in the Management of Acute Malnutrition
Acute Malnutrition With no Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnourished Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayat Gamal Darwish (+20 101 106 43, ayatgamal53@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim of the study (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06606951, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.