Status:
COMPLETED
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
Lead Sponsor:
Children's Health
Conditions:
Appendicitis
Appendicitis; Perforation
Eligibility:
All Genders
4-18 years
Phase:
NA
Brief 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 organ...
Detailed Description
Appendicitis is the most common urgent surgical procedure performed on children. Approximately one third of the population end up having complicated appendicitis with evidence of peritoneal contaminat...
Eligibility Criteria
Inclusion
- Patients with a post-operative diagnosis of complicated appendicitis who undergo an immediate appendectomy.
- Patients between the ages of 4 and 18 years of age.
Exclusion
- Patients diagnosed with an complicated appendicitis with deferred appendectomy or non-perforated appendicitis
- Patients that have a history of being immunosuppressed, on immunosuppression therapy, or long-term steroid therapy within the last month.
- Patients that have central line access.
- Patients under 4 years of age.
- Patients that are developmentally delayed and cannot ambulate at baseline.
- Patients with significant past medical history.
- Patients that are in Child Protective Services custody.
- Patients that are incarcerated.
- Patients that are pregnant.
- Patients that speak languages other than English and Spanish.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT04529980
Start Date
September 8 2020
End Date
February 28 2022
Last Update
August 13 2024
Active Locations (1)
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1
Children's Health Children's Medical Center
Dallas, Texas, United States, 75235