Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT06090708
Collaborator
(none)
60
1
2
8.8
6.8

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: yogurt with probiotic bacteria
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
Effect of Mothers' Application of Yogurt Probiotic Bacteria on Relieving Their Young Children's Acute Gastroenteritis
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Jul 27, 2023
Actual Study Completion Date :
Jul 27, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

Children with acute gastroenteritis received standard hospital care and the prescribed medication of control group for acute gastroenteritis.

Experimental: Probiotic Study Group

Children with acute gastroenteritis received fresh probiotic yogurt (1st day of production) for three consecutive days in addition to standard hospital care and prescribed medication for acute gastroenteritis.

Dietary Supplement: yogurt with probiotic bacteria
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.

Outcome Measures

Primary Outcome Measures

  1. Experience of diarrhea [before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.]

    yes/no

  2. Consistency of diarrhea [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 [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 [before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.]

    times /day.

  5. Odor of diarrhea [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 [before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.]

    /days.

  7. Experience of Vomiting [before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.]

    Yes/ no

  8. Amount of Vomiting [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 [before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.]

    times /day.

  10. Consistency of Vomiting [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 [before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.]

    /days.

  12. General condition of child [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 [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 [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 [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 Outcome Measures

  1. children's age/ [before data collection]

    year(s)

  2. gender/ [before data collection]

    male, female

  3. residence/ [before data collection]

    urban,rural

  4. type of feeding [before data collection]

    breast feeding, bottle feeding, mixed type, ordinary

  5. diagnosis [before data collection]

    gastroenteritis, bronchitis

  6. prescribed medication [before data collection]

    antiemetics, fluids therapy, antibiotics

  7. children's weight [before data collection]

    /kgs

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Year to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • newly admitted children with no or some dehydration and with acute gastroenteritis.
Exclusion Criteria:
  • bloody watery diarrhea

Contacts and Locations

Locations

Site City State Country Postal Code
1 inpatient medical ward for gastroenteritis in El-Raml Children's Hospital (Wingat) at Alexandria. Alexandria Egypt

Sponsors and Collaborators

  • Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alexandria University
ClinicalTrials.gov Identifier:
NCT06090708
Other Study ID Numbers:
  • Pro
First Posted:
Oct 19, 2023
Last Update Posted:
Oct 19, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alexandria University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 19, 2023