Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis

October 13, 2023 updated by: Alexandria University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Experience of diarrhea
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
yes/no
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Consistency of diarrhea
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
times /day.
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Odor of diarrhea
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
/days.
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Experience of Vomiting
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Yes/ no
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Amount of Vomiting
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
times /day.
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Consistency of Vomiting
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
/days.
before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
General condition of child
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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
Time Frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
children's age/
Time Frame: before data collection
year(s)
before data collection
gender/
Time Frame: before data collection
male, female
before data collection
residence/
Time Frame: before data collection
urban,rural
before data collection
type of feeding
Time Frame: before data collection
breast feeding, bottle feeding, mixed type, ordinary
before data collection
diagnosis
Time Frame: before data collection
gastroenteritis, bronchitis
before data collection
prescribed medication
Time Frame: before data collection
antiemetics, fluids therapy, antibiotics
before data collection
children's weight
Time Frame: before data collection
/kgs
before data collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 9, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 19, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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