Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

Effect of Mothers' Application of Yogurt Probiotic Bacteria on Relieving Their Young Children's 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).

Study Overview

• Status: Completed
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Dietary supplement: yogurt with probiotic bacteria

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• bloody watery diarrhea

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience of diarrhea	yes/no	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Consistency of diarrhea	Soft/ watery/ abnormal constitute	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Amount of diarrhea	Small / moderate/ large/ severe	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Frequency of diarrhea	times /day.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Odor of diarrhea	No odor/ offensive odor	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Duration of diarrhea	/days.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Experience of Vomiting	Yes/ no	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Amount of Vomiting	Small / moderate/ large/ severe	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Frequency of Vomiting	times /day.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Consistency of Vomiting	Soft/ watery/ abnormal constitute	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Duration of Vomiting	/days.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
General condition of child	Normal/ Restless, irritable/ Lethargic or unconscious	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Eye	Normal/ Sunken eyes/ Very Sunken eyes	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Thirsty	Drink normally/ Drinks eagerly, thirsty/ Drinks poorly or unable to drink	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Skin pinch	Goes back quickly/ Goes back slowly/ Goes back very slowly	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
children's age/	year(s)	before data collection
gender/	male, female	before data collection
residence/	urban,rural	before data collection
type of feeding	breast feeding, bottle feeding, mixed type, ordinary	before data collection
diagnosis	gastroenteritis, bronchitis	before data collection
prescribed medication	antiemetics, fluids therapy, antibiotics	before data collection
children's weight	/kgs	before data collection

Collaborators and Investigators

• Sponsor: Alexandria University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): July 27, 2023

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 13, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Gastroenteritis; Yogurt Probiotic Bacteria; young Children
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: Pro

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No