Probiotics and Antibiotic Associated Diarrhea in Pediatric Complicated Appendicitis
Condition: Appendicitis; Appendicitis; Perforation
MeSH terms: Appendicitis; Diarrhea
Study type: Interventional

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)
    

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 contamination and infection or abscess requiring the use of IV
      antibiotics and prolonged hospital stay. Antibiotic Associated Diarrhea (AAD) is a common
      complication seen in both outpatient and inpatient settings in approximately a third of all
      patients treated with antibiotics (Mantegazza, et al., 2018). In particular, pediatric
      patients experience ADD 11-62% of the time and can up upwards to 80% in hospitalized toddlers
      (Mantegazza, et al., 2018). Current literature defines AAD as three or more liquid stools per
      day. The causes of AAD are often related to the use of multiple antibiotics, prolonged
      hospital stay and gastrointestinal surgery. Antibiotics often disturb the normal enteric
      microbiome in the gut and allow for an increased growth of pathogens (Hojsak, 2017). AAD can
      occur as late as six to eight weeks after antibiotic exposure. 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.This study does not intend to investigate route of administration, dose, patient
      population, or other factor that significantly increases the risk (or decreases the
      acceptability of the risk) associated with the use of the dietary supplement.At Children's
      Medical Center, the investigators see over 1000 cases of appendicitis a year with
      approximately 1/3 of those patients being complicated appendicitis. For those requiring
      immediate appendectomy, the typical course of treatment include surgery, admission to the
      hospital for 3 to 5 days, administration of IV antibiotics while in hospital, and discharge
      orders for oral antibiotics to complete their treatment. The investigators propose to perform
      a randomized controlled trial where one group of patients will receive probiotic therapy and
      another group of patients does not. The investigators hypothesize patients given probiotics
      after a diagnosis of complicated appendicitis with immediate appendectomy who receive
      antibiotic treatment during their inpatient stay will decrease the overall length of stay
      (LOS) by 25% vs the LOS in those patients who do not receive probiotics.
    

Intervention name(s): Lactobacillus rhamnosus GG (LGG) Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 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.; Placebo
Other intervention name(s): Culturelle Probiotics Digestive Health
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Those randomized to the treatment group will be given probiotic therapy until discharge, while those randomized to the placebo group will be given a placebo until discharge.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Appendicitis; Probiotics