Status:
UNKNOWN
Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Diarrhea Caused by Drug
Abdominal Pain
Eligibility:
All Genders
12-12 years
Phase:
NA
Brief Summary
This is a prospective multicenter pediatric double-blind, randomized placebo-controlled, parallel group clinical trial intended to evaluate the efficacy, safety and tolerability of a combined probioti...
Detailed Description
Eligible children will be randomly assigned to receive the combined probiotic study product (Noos, Roma, Italia)(BCCMTM Bacterial Collection of Ghent, Belgium, Italian Patent: 102016000011071, Interna...
Eligibility Criteria
Inclusion
- Inclusion Criteria (all of the following):
- Children aged 12 months to 12 years
- Proven or suspected bacterial infection
- Inpatient children needed antibiotic treatment
- Oral or intravenous or intramuscular antibiotic administration with at least 2 days of duration
- Parental informed consent to the participation to the study
- Exclusion Criteria:
- Age below 12 months or above 12 years
- Infections with no or only one day of antibiotic treatment
- Sepsis or severe generalized infection
- Pancreatitis
- Known immunodeficiency or chronic gastrointestinal diseases or heart disease
- Oncologic patients
- Severe neurological impairment or lack of verbal expression
- Enteral or parenteral nutrition
- Gastrointestinal malformations or abdominal surgical interventions
- Central line catheter
- Acute or chronic diarrhea when starting antibiotics
- Current or recent (in the last four weeks) use of any probiotic product
- Antibiotic treatment started earlier than 24 hours before enrollment
- Absence of parental consent
Exclusion
Key Trial Info
Start Date :
May 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 13 2022
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04836013
Start Date
May 13 2021
End Date
April 13 2022
Last Update
May 4 2021
Active Locations (1)
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1
Silvia Salvatore
Varese, Italy