Combined Lactobacilli (Reuteri LMG P-27481 and GG ATCC 53103) to Prevent Antibiotic Associated Symptoms in Children

NCT04836013 | Unknown

• 1 other identifier: 52265
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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 probiotic (LGG and L. reuteri LMG P-27481) in the prevention of antibiotic associated diarrhea and gastrointestinal symptoms in hospitalised children treated with antibiotics for proven or suspected bacterial infection.

Conditions

Diarrhea Caused by Drug; Abdominal Pain

Keywords

antibiotics; diarrhea; probiotics; Lactobacillus; children; abdominal pain

Outcome Measures

Primary Outcomes (1)

• Incidence of antibiotic-associated diarrhea, defined as episodes of otherwise unexplained diarrhea (≥3 loose or liquid stools per day with negative viral and bacterial stool tests), recorded by instructed parents in a structured daily diary.

  Both Intention to treat (ITT) and Multivariate linear regression models analysis taking into account age, sex, mode of antibiotic delivery, and the kind of antibiotics and comparison between the two groups will be performed.The relative risk (RR), 95% confidence interval (CI), and number needed to treat (NNT) will also be calculated. The difference between study groups will be considered significant when P-value \<0.05 or when the 95% CI for RR will not exceed 1.0.

  From the second day after starting antibiotic treatment to 2 weeks after stopping antibiotics

Secondary Outcomes (1)

• Number of children with episodes of infective diarrhea; dehydration (by Vesikary scale), fever, abdominal pain, vomiting and constipation (by Bristol stool chart); general well being (by 1-10 scale) as assessed by patient's record form.

  6 months from enrolling

Other Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From enrolling to all the period of intervention (1 month)

• Number of participants with abnormal fecal inflammatory markers (calprotectin, lactoferrine, IgA, IL10 and TNF-α) and urine metabolomic profile

  The additional stool and urine sample will be collected at recruitment, after 1 month and after 6 months from enrollment.

Study Arms (2)

Probiotic group

EXPERIMENTAL

Lactobacillus reuteri LMG P-27481 and Lactobacillus rhamnosus GG (ATCC 53103), sucralose and isomalt as an oral stick formulation of 1,6 g with a concentration of probiotic of 2x100bilion colony forming unit (CFU) per stick.

Dietary Supplement: combined Lactobacilli

Placebo group

PLACEBO COMPARATOR

The placebo will contain 1.6 g per stick of sucralose and isomalt

Other: Placebo

Interventions

combined Lactobacilli DIETARY_SUPPLEMENT

1 oral stick per day for 30 days starting the day of antibiotic treatment

Probiotic group

Placebo OTHER

1 oral stick per day for 30 days starting the day of antibiotic treatment

Placebo group

Eligibility Criteria

• Age: 12 Months - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi dell'Insubria: lead

Study Sites (1)

Silvia Salvatore

Varese, Italy

Location

MeSH Terms

Conditions

Abdominal Pain; Diarrhea

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Model Details: Double blind placebo controlled prospective trial

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: April 8, 2021
• Study Start: May 13, 2021
• Primary Completion: November 30, 2021
• Study Completion: April 13, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the publication of the study to 5 years
• Access Criteria: Mailing to silvia.salvatore@uninsubria.it

Locations

IT (1)