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Efficacy and Safety of Saccharomyces Boulardii in Treatment of Acute Diarrhea in Children Aged 6 Months to 5 Years Old

8. september 2026 opdateret af: Nguyễn Thị Phương Thão, Can Tho University of Medicine and Pharmacy
This study aimed to evaluate the effectiveness of saccharomyces-based treatment in children with acute diarrhea aged 6 months to 5 years compared to children treated with standard methods.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A total of 206 children diagnosed with acute diarrhea will be evaluated and divided into two groups based on a random distribution list: Group A and Group B.

Group A will be treated with standard methods including fluid replacement and zinc according to the Ministry of Health's protocol.

Group B will be treated similarly to Group A, but with the addition of Saccharomyces boulardii at a dose of 250 to 750 mg per day until discharge.

Both groups of children will receive the same counseling and monitoring, with guidance provided to parents.

Caregivers are advised to record symptoms and stool diaries daily.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

206

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Vietnam
      • Can Tho, Vietnam, 900000
        • Can Tho University of Medicine and Pharmacy
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Age from 6 months to 5 years old
  • Children are diagnosed with acute diarrhea according to WHO criteria.

Exclusion Criteria:

  • Bloody, mucous stools.
  • Signs of sepsis requiring admission to the Intensive Care Unit.
  • Currently suffering from chronic diseases such as cow's milk protein allergy, nephrotic syndrome, immunodeficiency, and systemic diseases.
  • Currently using immunosuppressant drugs.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Saccharomyces boulardii
Saccharomyces boulardii is a type of yeast that helps to quickly restore the intestinal mucosal barrier and the gut microbiome, significantly shortening hospital stays.
Medicin: Saccharomyces Boulardii Probiotic Supplement
Children will receive standard treatment including fluid and zinc supplementation. In addition, they will receive Saccharomyces boulardii supplementation from admission to discharge.
Aktiv komparator: Standard treatment includes fluid replacement and zinc supplementation.
Treatment should follow standard protocols with fluid replacement and zinc supplementation, but no additional Saccharomyces boulardii should be added until discharge.
Medicin: The child will be treated with standard method
Children will be treated with standard methods involving fluid and zinc supplementation, without the use of any probiotics.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Duration of diarrhea
Tidsramme: Immediately after the intervention

The cessation of acute diarrhea is determined when children met following criteria:

  1. Passing soft or formed stools twice in a row.
  2. No bowel movements recorded for 12 consecutive hours.
  3. Stool consistency returns to normal, corresponding to categories 3 to 5 on the Bristol stool scale.
Immediately after the intervention
The frequency of stool
Tidsramme: At day 1, 3, 5
Total number of bowel movements per day
At day 1, 3, 5
Stool consistency assessed by Bristol stool chart
Tidsramme: At day 1, 3, 5
The Bristol stool chart has 7 pictures of stool appearance. The number 1 mean hard stool and number 7 mean watery stool.
At day 1, 3, 5

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of hospitalization
Tidsramme: Immediately after the intervention
The total length of hospitalization, measured in days
Immediately after the intervention
Adverse events
Tidsramme: Immediately after the intervention
The occurrence of adverse events during treatment, including such as rash and bloating.
Immediately after the intervention
Cost effectiveness
Tidsramme: Immediately after the intervention
Total Cost per child from date of admission until discharge
Immediately after the intervention
Rate of Hospital readmission
Tidsramme: At day 14 and 28 after discharge from the hospital.
The proportion of participants who were readmitted to the hospital after discharge
At day 14 and 28 after discharge from the hospital.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Can Tho University of Medicine and Pharmacy

Efterforskere

  • Studiestol: Thao Thi Phuong Nguyen, M.D, Can Tho University of Medicine and Pharmacy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

30. august 2028

Studieafslutning (Anslået)

30. august 2028

Datoer for studieregistrering

Først indsendt

31. august 2026

Først indsendt, der opfyldte QC-kriterier

8. september 2026

Først opslået (Faktiske)

10. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 2857/QĐ-ĐHYDCT

Plan for individuelle deltagerdata (IPD)

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INGEN

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