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Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis

NCT04529980 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2024-08-13

Study results available
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Summary

To determine the effectiveness of the use of probiotics in patients with a diagnosis of complicated appendicitis on antibiotic associated diarrhea (AAD). Probiotics are defined as live microbial organisms that when administered in sufficient amounts, can provide a protective benefit to the individual patient. The use of probiotics in a pediatric population exposed to antibiotics and gastrointestinal surgery such as an appendectomy may provide a protective effect and prevent antibiotic associated diarrhea (ADD)

Conditions

  • Appendicitis
  • Appendicitis; Perforation

Interventions

DIETARY_SUPPLEMENT

Lactobacillus rhamnosus GG (LGG) Probiotic

Lactobacillus rhanmosus GG(LGG®)(Culturelle) is an over the counter dietary supplement that can help to restore the balance in the gut by promoting colonization to support better digestion and immune health.

DIETARY_SUPPLEMENT

Placebo

Placebo

Sponsors & Collaborators

  • Children's Health

    lead OTHER

Principal Investigators

  • Mayra Garcia, APRN, CNS · Children's Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-02-28
Completion
2022-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04529980 on ClinicalTrials.gov