Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children
PEARL
1 other identifier
interventional
1,325
1 country
1
Brief Summary
Recent studies showed that intestinal microbiota consist more than thousand bacteria, and these microorganisms play the role as balance and continuity of the anatomical and functional integrity gastrointestinal tract. Chronic diseases, nutritional factors, lifestyle factors and medications including antibiotics changes the host microbiota in short or long-term period. Antibiotics are the most commonly used drugs in pediatrics routine practice. Although frequency and severity of side effects alter the choice of drug, mild complications may be taken into consideration for treatment by a physician in the profit and loss balance. Our study group (PROBAGE Working Group) have been recently showed that Lactobacillus reuteri DSM 17938 reduced the duration of diarrhea in children with acute infectious diarrhea, and are safe and well-tolerated. In this study the investigators aim to evaluate the potential effect of Lactobacillus reuteri DSM 17938 on the prevention of antibiotic associated diarrhea in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2017
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 15, 2021
February 1, 2021
3.1 years
May 2, 2016
February 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of antibiotic associated diarrhea
The frequency and consistency of the stools were recorded daily according to Bristol score; a score \<5 is described as normalization of stool and score equal or above 5 defined as diarrhea. Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug, Graded According to NCI CTCAE Version 3.0
8 weeks time period after 1st day of antibiotic use
Secondary Outcomes (4)
Incidence of antibiotic associated diarrhea during antibiotic treatment
10-14 days (depends on the antibiotic treatment)
Incidence of antibiotic associated diarrhea after antibiotic treatment
From 11-15th days of intervention to 56 days
Evaluation of antibiotic-associated diarrhea in patients who developed diarrhea severity
56 days
The frequency of other gastrointestinal symptoms other than diarrhea during the study (will be evaluated using the Gastrointestinal Symptom Rating Score)
56 days
Study Arms (4)
Study group 1
EXPERIMENTALAmoxicilline-clavulanic acid (50-90 mg/kg/day, twice daily) and Lactobacillus reuteri DSM 17938 (5 drops per day, same time with the first dose of antibiotics). Study Group 1a will received L. reuteri for 10-14 days. Study Group 1b will received L. reuteri for 21 days.
Study group 2
PLACEBO COMPARATORAmoxicillin-clavulanic acid (50-90 mg / kg / day) and placebo ( 5 drops per day, same time with the antibiotics) Study Group 2a will received placebo for 10-14 days. Study Group 2b will received placebo for 21 days.
Study group 3
EXPERIMENTALAmoxicilline-clavulanic acid (50-90 mg/kg/day, twice daily) and Lactobacillus reuteri DSM 17938 (2 x 5 drops per day) Study Group 3a will received L. reuteri for 10-14 days. Study Group 3b will received L. reuteri for 21 days.
Study group 4
PLACEBO COMPARATORAmoxicillin-clavulanic acid (50-90 mg / kg / day) and placebo ( 2 x 5 drops per day, same time with the antibiotics) Study Group 4a will received placebo for 10-14 days. Study Group 4b will received placebo for 21 days.
Interventions
Comparison the effects of Lactobacillus reuteri DSM 17938 and placebo for prevention of antibiotic associated diarrhea and also plan to compare the duration of treatment for on efficacy.
Comparison the effects of Lactobacillus reuteri DSM 17938 and placebo for prevention of antibiotic associated diarrhea and also plan to compare the duration of treatment for on
All study patients will received amoxicillin-clavulanic acid at the dose of 50-90 mg/kg/day.
Eligibility Criteria
You may qualify if:
- Children receiving amoxicilline-clavulanic acid (50-90 mg/kg/day, twice daily) due to acute otitis media or acute sinusitis
You may not qualify if:
- Receiving antibiotic and/or probiotic, 8 weeks before the study
- Chronic gastrointestinal system disorders
- Congenital anomalies
- Chronic diseases
- Chemotherapy and radiotherapy
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eskisehir Osmangazi Universitylead
- Hacettepe Universitycollaborator
- Acıbadem University School of Medicinecollaborator
- Umraniye Education and Research Hospitalcollaborator
- Sisli Hamidiye Etfal Training and Research Hospitalcollaborator
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organizationcollaborator
- Ege University Medical Schoolcollaborator
- Yuzuncu Yil Universitycollaborator
- Goztepe Training and Research Hospitalcollaborator
- Erzurum Regional Training & Research Hospitalcollaborator
- Namik Kemal Universitycollaborator
Study Sites (1)
Sisli Etfal Training and Research Hospital,
Istanbul, 34000, Turkey (Türkiye)
Related Publications (1)
Dinleyici EC, Ozen M, Guven S, Dalgic N, Karbuz A, Sutcu M, Turel O, Oz FN, Kirli U, Yasar Durmus S, Yazar AS, Cakin ZE, Vandenplas Y, Kara A. Effect of Limosilactobacillus reuteri DSM17938 to prevent antibiotic-associated diarrhea in children: prospective, multi-center, randomized, placebo-controlled clinical trial (PEARL Study). Eur J Pediatr. 2025 Jun 9;184(7):408. doi: 10.1007/s00431-025-06249-8.
PMID: 40488914DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in Pediatrics
Study Record Dates
First Submitted
May 2, 2016
First Posted
May 6, 2016
Study Start
June 1, 2017
Primary Completion
July 1, 2020
Study Completion
December 1, 2020
Last Updated
February 15, 2021
Record last verified: 2021-02