Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06090708
• Other study ID #: Pro
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: July 27, 2023

Study information

• Verified date: October 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 27, 2023
• Est. primary completion date: July 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• bloody watery diarrhea

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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. — View 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	children's age/	year(s)	before data collection
Other	gender/	male, female	before data collection
Other	residence/	urban,rural	before data collection
Other	type of feeding	breast feeding, bottle feeding, mixed type, ordinary	before data collection
Other	diagnosis	gastroenteritis, bronchitis	before data collection
Other	prescribed medication	antiemetics, fluids therapy, antibiotics	before data collection
Other	children's weight	/kgs	before data collection
Primary	Experience of diarrhea	yes/no	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Primary	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.
Primary	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.
Primary	Frequency of diarrhea	times /day.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Primary	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.
Primary	Duration of diarrhea	/days.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Primary	Experience of Vomiting	Yes/ no	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Primary	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.
Primary	Frequency of Vomiting	times /day.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Primary	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.
Primary	Duration of Vomiting	/days.	before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Primary	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.
Primary	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.
Primary	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.
Primary	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.