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Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea

20. august 2026 opdateret af: Gul Jabeen, University of Child Health Sciences and Children's Hospital, Lahore

Effectiveness of Saccharomyces Boulardii in the Prevention of Antibiotic-Associated Diarrhea Among Children Receiving Co-amoxiclav for Upper Respiratory Tract Infection: A Randomized Control Trial

Antibiotic-associated diarrhea (AAD) is a common adverse effect in pediatric patients receiving broad-spectrum antibiotics such as co-amoxiclav for upper respiratory tract infections (URTI). This study aims to evaluate the effectiveness of the probiotic Saccharomyces boulardii in preventing antibiotic-associated diarrhea among children aged 6 months to 5 years receiving co-amoxiclav. Participants will be randomly allocated to receive either standard co-amoxiclav therapy alone or co-amoxiclav combined with Saccharomyces boulardii for 5 days. The primary objective is to evaluate whether the addition of Saccharomyces boulardii reduces the incidence of diarrhea during and up to 14 days following antibiotic therapy.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Acute upper respiratory tract infections (URTI) frequently lead to broad-spectrum antibiotic prescriptions such as co-amoxiclav, which can disrupt the gut microbiota and cause antibiotic-associated diarrhea (AAD).

This single-blind randomized controlled trial will be conducted at the Pediatric Medicine Outpatient Department, University of Child Health Sciences, The Children's Hospital, Lahore. A total of 88 children aged 6 months to 5 years presenting with URTI and prescribed co-amoxiclav will be enrolled after obtaining written informed consent from their parents or legal guardians.

Participants will be randomized into two equal groups (n = 44 each):

Group A (Control): Standard dose of oral co-amoxiclav (30 mg/kg/day) for 5 days.

Group B (Intervention): Standard dose of oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.

Clinical response, stool frequency, and stool consistency (graded using the WHO scale) will be assessed telephonically and during clinical follow-up at Day 5 (completion of antibiotic regimen) and at Day 14. Any child developing severe dehydration or high-grade loose stools will be managed in accordance with institutional safety protocols.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • University of Child Health sciences, Children's hospital,Lahore
        • 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

Ingen

Beskrivelse

Inclusion Criteria:

  • Children aged 6 months to 5 years presenting with upper respiratory tract infection (URTI)
  • Prescribed standard oral co-amoxiclav therapy
  • Both male and female patients
  • Written informed consent provided by parents or legal guardians

Exclusion Criteria:

  • Presence of diarrhea at the time of study enrollment
  • Prior use of probiotics during the current course of illness
  • Receipt of any antibiotic other than co-amoxiclav within the 72 hours preceding enrollment
  • Concomitant use of other medications
  • Known allergy to co-amoxiclav or the probiotic Saccharomyces boulardii
  • Confirmed immunodeficiency disorder or current receipt of immunosuppressive therapy
  • History of chronic diarrhea
  • Presence of 3rd degree (severe) malnutrition
  • Presence of systemic symptoms or infections other than URTI (e.g., lower respiratory tract infection, jaundice)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Group A: Control Group
Participants receive standard oral co-amoxiclav (30 mg/kg/day) for 5 days.
Medicin: Co-amoxiclav
30 mg/kg/day orally for 5 days.
Eksperimentel: Group B:Intervention Group
Participants receive standard oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.
Medicin: Co-amoxiclav
30 mg/kg/day orally for 5 days.
Kosttilskud: Saccharomyces boulardii
Administered orally alongside standard co-amoxiclav for 5 days.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Antibiotic-Associated Diarrhea (AAD)
Tidsramme: From initiation of treatment through Day 14
Proportion of participants who develop antibiotic-associated diarrhea, defined as 3 or more unformed/loose stools per day or a single episode of watery stool starting at least 2 hours post-initiation of co-amoxiclav therapy.
From initiation of treatment through Day 14

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Stool Frequency
Tidsramme: Assessed at Day 1, Day 5, and Day 14.
Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, >4 times per day).
Assessed at Day 1, Day 5, and Day 14.
Stool Consistency Grade
Tidsramme: Assessed at Day 1, Day 5, and Day 14
Stool consistency graded according to the WHO grading scale: Grade 1 (Normal formed), Grade 2 (Semi-formed), Grade 3 (Liquid stools taking shape of container), Grade 4 (Watery stools with flakes, opaque), Grade 5 (Watery stools with few flakes, translucent).
Assessed at Day 1, Day 5, and Day 14
Duration of Diarrhea
Tidsramme: Up to Day 14 post-initiation of therapy
Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea.
Up to Day 14 post-initiation of therapy

Samarbejdspartnere og efterforskere

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

Sponsor

University of Child Health Sciences and Children's Hospital, Lahore

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)

1. september 2026

Primær færdiggørelse (Anslået)

1. februar 2027

Studieafslutning (Anslået)

1. maj 2027

Datoer for studieregistrering

Først indsendt

20. august 2026

Først indsendt, der opfyldte QC-kriterier

20. august 2026

Først opslået (Faktiske)

25. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCHS-MD-01

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