Effectiveness of Saccharomyces Boulardii in Prevention of Antibiotic Associated Diarrhea
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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Gul Jabeen, MBBS
- 전화번호: +923330937322
- 이메일: aabigul96@gmail.com
연구 장소
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Punjab Province
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Lahore, Punjab Province, 파키스탄
- University of Child Health sciences, Children's hospital,Lahore
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연락하다:
- Gul Jabeen, MBBS
- 전화번호: +923330937322
- 이메일: aabigul96@gmail.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Group A: Control Group
Participants receive standard oral co-amoxiclav (30 mg/kg/day) for 5 days.
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30 mg/kg/day orally for 5 days.
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실험적: Group B:Intervention Group
Participants receive standard oral co-amoxiclav (30 mg/kg/day) plus oral Saccharomyces boulardii for 5 days.
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30 mg/kg/day orally for 5 days.
Administered orally alongside standard co-amoxiclav for 5 days.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Incidence of Antibiotic-Associated Diarrhea (AAD)
기간: From initiation of treatment through Day 14
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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.
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From initiation of treatment through Day 14
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Stool Frequency
기간: Assessed at Day 1, Day 5, and Day 14.
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Number of stool passages per day categorized on a standardized scale (Nil, 1-2, 3-4, >4 times per day).
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Assessed at Day 1, Day 5, and Day 14.
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Stool Consistency Grade
기간: Assessed at Day 1, Day 5, and Day 14
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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).
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Assessed at Day 1, Day 5, and Day 14
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Duration of Diarrhea
기간: Up to Day 14 post-initiation of therapy
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Total duration (in days) of diarrheal episodes in participants who develop antibiotic-associated diarrhea.
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Up to Day 14 post-initiation of therapy
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UCHS-MD-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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