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Not yet recruitingNCT06606951Updated Sep 23, 2024

Effect Of Probiotics Supplementation on Outcome Of Malnourished Children

An observational study in Malnourished Children, sponsored by Assiut University. Not yet recruiting. Open to participants aged 5 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-23.

Sponsored by Assiut University · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2025, 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Ages
5 Months to 5 Years
Sex
All
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Study summary

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

02

Conditions studied

  • Malnourished Children

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03

In context

Malnutrition

1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.

This study's planned enrollment of 102 is below the median of 203 across 388 observational studies indexed under Malnutrition.

Browse Malnutrition studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Months to 5 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • age below 6 month and above 5 years
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. Aim of the study

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

    Time frame: Baseline

  2. perinatal history

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

    Time frame: Baseline

  3. Present history

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

    Time frame: Baseline

  4. Feeding history

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

    Time frame: Baseline

  5. Maternal history

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

    Time frame: Baseline

  6. Investigations

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

    Time frame: Baseline

  7. Sample size

    102 patients

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

08

References and documents

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 27541692 ↗
  • Bakker 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 26447957 ↗
  • van 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06606951
Lead sponsor
Assiut University
Responsible party
Ayat Gamal Darwish (71515,Assuit, Assiut University) — Principal investigator
First posted
Sep 23, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Nov 30, 2025 (estimated)
Completion
Jan 1, 2026 (estimated)
Last update
Sep 23, 2024

Study contacts

Ayat Gamal Darwish
Contact
ayatgamal53@gmail.com
+20 101 106 43
Amir Mohamed Abo El Gheet
Contact
Amircle76@yahoo.com
01065742277

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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