NCT06090708

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

October 9, 2023

Last Update Submit

October 13, 2023

Conditions

Acute Gastroenteritis

Keywords

Yogurt Probiotic Bacteriayoung ChildrenGastroenteritis

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (7)

  • children's age/

    before data collection

  • gender/

    before data collection

  • residence/

    before data collection

  • +4 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

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

Probiotic Study Group

EXPERIMENTAL

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

Interventions

yogurt with probiotic bacteriaDIETARY_SUPPLEMENT

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.

Probiotic Study Group

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • bloody watery diarrhea

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Alexandria, Egypt

Location

Related 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.

    PMID: 27048895BACKGROUND

  • 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.

    PMID: 25799959BACKGROUND

  • 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.

    PMID: 32953642BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Gastroenteritis

Interventions

Yogurt

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Cultured Milk ProductsMilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaFermented FoodsDairy ProductsFoodFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2023

First Posted

October 19, 2023

Study Start

November 1, 2022

Primary Completion

July 27, 2023

Study Completion

July 27, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

EG(1)