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Completed

NCT Number: NCT06090708

Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

The goal of this clinical trial is to test the effect of mothers' application of yogurt probiotic bacteria on relieving their young children's acute gastroenteritis in children had two to five years old. The main hypothesis is children with acute gastroenteritis who receive yogurt probiotic bacteria exhibit less diarrhea, vomiting and dehydration than those who don't.The study subjects were divided into two equal groups (probiotic study group and control group).

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Key information

Age range

1 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

inpatient medical ward for gastroenteritis in El-Raml Children's Hospital (Wingat) at Alexandria.

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • newly admitted children with no or some dehydration and with acute gastroenteritis.

Exclusion criteria

  • bloody watery diarrhea

Treatment and study plan

yogurt with probiotic bacteria

Dietary Supplement

Children in probiotic study group were received 15 mg/kg of market available fresh probiotic yogurt after stopping vomiting every four to six hours for three consecutive days beside to the standard hospital care and the prescribed medication for acute gastroenteritis.

Primary outcomes

  1. Experience of diarrhea

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    yes/no

  2. Consistency of diarrhea

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Soft/ watery/ abnormal constitute

  3. Amount of diarrhea

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Small / moderate/ large/ severe

  4. Frequency of diarrhea

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    times /day.

  5. Odor of diarrhea

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    No odor/ offensive odor

  6. Duration of diarrhea

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    /days.

  7. Experience of Vomiting

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Yes/ no

  8. Amount of Vomiting

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Small / moderate/ large/ severe

  9. Frequency of Vomiting

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    times /day.

  10. Consistency of Vomiting

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Soft/ watery/ abnormal constitute

  11. Duration of Vomiting

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    /days.

  12. General condition of child

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Normal/ Restless, irritable/ Lethargic or unconscious

  13. Eye

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Normal/ Sunken eyes/ Very Sunken eyes

  14. Thirsty

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Drink normally/ Drinks eagerly, thirsty/ Drinks poorly or unable to drink

  15. Skin pinch

    Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

    Goes back quickly/ Goes back slowly/ Goes back very slowly

Other outcomes

  1. children's age/

    Time frame: before data collection

    year(s)

  2. gender/

    Time frame: before data collection

    male, female

  3. residence/

    Time frame: before data collection

    urban,rural

  4. type of feeding

    Time frame: before data collection

    breast feeding, bottle feeding, mixed type, ordinary

  5. diagnosis

    Time frame: before data collection

    gastroenteritis, bronchitis

  6. prescribed medication

    Time frame: before data collection

    antiemetics, fluids therapy, antibiotics

  7. children's weight

    Time frame: before data collection

    /kgs

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Effect of Mothers' Application of Yogurt Probiotic Bacteria on Relieving Their Young Children's Acute Gastroenteritis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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