N/A
N=98
Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
Appendicitis · Appendicitis; Perforation
Bottom Line
View on ClinicalTrials.gov: NCT04529980 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Length of Hospital Stay — 121.55; 131.69 hours
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lactobacillus rhamnosus GG (LGG) Probiotic (Dietary_supplement); Placebo (Dietary_supplement)
- Age
- Pediatric, Adult · 4+ yrs
- Sex
- All
- Sponsor
- Children's Health
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospital Stay |
121.55; 131.69 | — |
| SECONDARY Number of Diarrhea Episodes Daily |
12.43; 9.50 | — |
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)
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04529980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.