Acute GastroenteritisNCT06090708
Yogurt Probiotic Bacteria on Relieving Young Children Acute Gastroenteritis
A study testing yogurt with probiotic bacteria in people with Acute Gastroenteritis, run by Alexandria University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 1 year to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Gastroenteritis
- What is being tested?
- yogurt with probiotic bacteria
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 27 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- newly admitted children with no or some dehydration and with acute gastroenteritis.
Who cannot join
- bloody watery diarrhea
Trial locations and contacts
1 site in 1 country.
Egypt1 site
inpatient medical ward for gastroenteritis in El-Raml Children's Hospital (Wingat) at Alexandria.
Alexandria
About this study
Official title: 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).
- Conditions
- Acute Gastroenteritis
- Being tested
- yogurt with probiotic bacteria
- Keywords
- Yogurt Probiotic Bacteria, young Children, Gastroenteritis
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: yogurt with probiotic bacteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Experience of diarrhea
yes/no
Measured: 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
Measured: 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
Measured: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Frequency of diarrhea
times /day.
Measured: 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
Measured: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Duration of diarrhea
/days.
Measured: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Experience of Vomiting
Yes/ no
Measured: 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
Measured: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Frequency of Vomiting
times /day.
Measured: 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
Measured: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Duration of Vomiting
/days.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2022
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090708
- Sponsor's protocol ID
- Pro
- Status last verified
- Oct 2023
- First submitted
- 9 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 27048895Cruchet 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.
PubMed 25799959Kluijfhout 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.
PubMed 32953642Sharif, 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 at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mothers' Application of Yogurt Probiotic Bacteria on Relieving Their Young Children's Acute Gastroenteritis
- ClinicalTrials.gov ID
- NCT06090708
- Acronym / sponsor ID
- Pro
- Conditions
- Acute Gastroenteritis
- Keywords
- Yogurt Probiotic Bacteria, young Children, Gastroenteritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: yogurt with probiotic bacteriaChildren 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. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- newly admitted children with no or some dehydration and with acute gastroenteritis.
Key exclusion criteria (1 listed)
- bloody watery diarrhea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| yogurt with probiotic bacteriaChildren 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. | Dietary supplement | Probiotic Study Group |
Primary outcome
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
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
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
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.
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
Duration of diarrhea
Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
/days.
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
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
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.
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
Duration of Vomiting
Time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.
/days.
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Background: PubMed 27048895Bertelsen 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.
- Background: PubMed 25799959Cruchet 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.
- Background: PubMed 32953642Kluijfhout 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.
- BackgroundSharif, 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yogurt with probiotic bacteria in people with Acute Gastroenteritis, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Experience of diarrhea (time frame: before intervention, after 1st day of study, after 2nd day of study, and after 3rd day of study.). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090708, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.