NCT06606951

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

September 23, 2024

Status Verified

September 1, 2024

Enrollment Period

11 months

First QC Date

September 5, 2024

Last Update Submit

September 18, 2024

Conditions

Outcome Measures

Primary Outcomes (7)

  • Aim of the study

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

    Baseline

  • perinatal history

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

    Baseline

  • Present history

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

    Baseline

  • Feeding history

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

    Baseline

  • Maternal history

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

    Baseline

  • Investigations

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

    Baseline

  • Sample size

    102 patients

    Baseline

Eligibility Criteria

Age5 Months - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • age below 6 month and above 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 27541692BACKGROUND
  • 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.

  • 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.

Central Study Contacts

Ayat Gamal Darwish

CONTACT

Amir Mohamed Abo El Gheet

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
71515,Assuit

Study Record Dates

First Submitted

September 5, 2024

First Posted

September 23, 2024

Study Start

January 1, 2025

Primary Completion

November 30, 2025

Study Completion

January 1, 2026

Last Updated

September 23, 2024

Record last verified: 2024-09