Back to resultsYogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis
Primary Purpose
Acute Gastroenteritis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
yogurt with probiotic bacteria
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Gastroenteritis focused on measuring Yogurt Probiotic Bacteria, young Children, Gastroenteritis
Eligibility Criteria
Inclusion Criteria: newly admitted children with no or some dehydration and with acute gastroenteritis. Exclusion Criteria: bloody watery diarrhea
Sites / Locations
- inpatient medical ward for gastroenteritis in El-Raml Children's Hospital (Wingat) at Alexandria.
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Probiotic Study Group
Arm Description
Children with acute gastroenteritis received standard hospital care and the prescribed medication of control group for acute gastroenteritis.
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.
Outcomes
Primary Outcome Measures
Experience of diarrhea
yes/no
Consistency of diarrhea
Soft/ watery/ abnormal constitute
Amount of diarrhea
Small / moderate/ large/ severe
Frequency of diarrhea
times /day.
Odor of diarrhea
No odor/ offensive odor
Duration of diarrhea
/days.
Experience of Vomiting
Yes/ no
Amount of Vomiting
Small / moderate/ large/ severe
Frequency of Vomiting
times /day.
Consistency of Vomiting
Soft/ watery/ abnormal constitute
Duration of Vomiting
/days.
General condition of child
Normal/ Restless, irritable/ Lethargic or unconscious
Eye
Normal/ Sunken eyes/ Very Sunken eyes
Thirsty
Drink normally/ Drinks eagerly, thirsty/ Drinks poorly or unable to drink
Skin pinch
Goes back quickly/ Goes back slowly/ Goes back very slowly
Secondary Outcome Measures
Full Information
NCT ID
NCT06090708
First Posted
October 9, 2023
Last Updated
October 13, 2023
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT06090708
Brief Title
Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis
Official Title
Effect of Mothers' Application of Yogurt Probiotic Bacteria on Relieving Their Young Children's Acute Gastroenteritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 27, 2023 (Actual)
Study Completion Date
July 27, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gastroenteritis
Keywords
Yogurt Probiotic Bacteria, young Children, Gastroenteritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Children with acute gastroenteritis received standard hospital care and the prescribed medication of control group for acute gastroenteritis.
Arm Title
Probiotic Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
yogurt with probiotic bacteria
Intervention Description
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 Outcome Measure Information:
Title
Experience of diarrhea
Description
yes/no
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Consistency of diarrhea
Description
Soft/ watery/ abnormal constitute
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Amount of diarrhea
Description
Small / moderate/ large/ severe
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Frequency of diarrhea
Description
times /day.
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Odor of diarrhea
Description
No odor/ offensive odor
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Duration of diarrhea
Description
/days.
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Experience of Vomiting
Description
Yes/ no
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Amount of Vomiting
Description
Small / moderate/ large/ severe
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Frequency of Vomiting
Description
times /day.
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Consistency of Vomiting
Description
Soft/ watery/ abnormal constitute
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Duration of Vomiting
Description
/days.
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
General condition of child
Description
Normal/ Restless, irritable/ Lethargic or unconscious
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Eye
Description
Normal/ Sunken eyes/ Very Sunken eyes
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Thirsty
Description
Drink normally/ Drinks eagerly, thirsty/ Drinks poorly or unable to drink
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Title
Skin pinch
Description
Goes back quickly/ Goes back slowly/ Goes back very slowly
Time Frame
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Other Pre-specified Outcome Measures:
Title
children's age/
Description
year(s)
Time Frame
before data collection
Title
gender/
Description
male, female
Time Frame
before data collection
Title
residence/
Description
urban,rural
Time Frame
before data collection
Title
type of feeding
Description
breast feeding, bottle feeding, mixed type, ordinary
Time Frame
before data collection
Title
diagnosis
Description
gastroenteritis, bronchitis
Time Frame
before data collection
Title
prescribed medication
Description
antiemetics, fluids therapy, antibiotics
Time Frame
before data collection
Title
children's weight
Description
/kgs
Time Frame
before data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
newly admitted children with no or some dehydration and with acute gastroenteritis.
Exclusion Criteria:
bloody watery diarrhea
Facility Information:
Facility Name
inpatient medical ward for gastroenteritis in El-Raml Children's Hospital (Wingat) at Alexandria.
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
27048895
Citation
Bertelsen RJ, Jensen ET, Ringel-Kulka T. Use of probiotics and prebiotics in infant feeding. Best Pract Res Clin Gastroenterol. 2016 Feb;30(1):39-48. doi: 10.1016/j.bpg.2016.01.001. Epub 2016 Jan 22.
Results Reference
background
PubMed Identifier
25799959
Citation
Cruchet S, Furnes R, Maruy A, Hebel E, Palacios J, Medina F, Ramirez N, Orsi M, Rondon L, Sdepanian V, Xochihua L, Ybarra M, Zablah RA. The use of probiotics in pediatric gastroenterology: a review of the literature and recommendations by Latin-American experts. Paediatr Drugs. 2015 Jun;17(3):199-216. doi: 10.1007/s40272-015-0124-6.
Results Reference
background
PubMed Identifier
32953642
Citation
Kluijfhout S, Trieu TV, Vandenplas Y. Efficacy of the Probiotic Probiotical Confirmed in Acute Gastroenteritis. Pediatr Gastroenterol Hepatol Nutr. 2020 Sep;23(5):464-471. doi: 10.5223/pghn.2020.23.5.464. Epub 2020 Aug 27.
Results Reference
background
Citation
Sharif, A., Kheirkhah, D., Shamsesfandabadi, P., Masoudi, S., Ajorpaz, N., & Sharif, M. (2017, 01/01). Comparison of Regular and Probiotic Yogurts in Treatment of Acute Watery Diarrhea in Children. Journal of Probiotics & Health, 05. https://doi.org/10.4172/2329-8901.1000164
Results Reference
background
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Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis
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