Clinical trial NCT06090708: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Gastroenteritis
Keywords: Yogurt Probiotic Bacteria
young Children
Gastroenteritis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* bloody watery diarrhea

Primary outcomes:
measure: Experience of diarrhea
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Consistency of diarrhea
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Amount of diarrhea
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Frequency of diarrhea
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Odor of diarrhea
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Duration of diarrhea
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Experience of Vomiting
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Amount of Vomiting
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Frequency of Vomiting
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Consistency of Vomiting
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Duration of Vomiting
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: General condition of child
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Eye
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Thirsty
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
measure: Skin pinch
timeFrame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Secondary outcomes:
Other outcomes:
measure: children's age/
timeFrame: before data collection
measure: gender/
timeFrame: before data collection
measure: residence/
timeFrame: before data collection
measure: type of feeding
timeFrame: before data collection
measure: diagnosis
timeFrame: before data collection
measure: prescribed medication
timeFrame: before data collection
measure: children's weight
timeFrame: before data collection
Locations:
city: Alexandria
country: Egypt
facility: inpatient medical ward for gastroenteritis in El-Raml Children's Hospital (Wingat) at Alexandria.
Study officials:
References:
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.
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.
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.
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