Rifaximin for Pediatric Inflammatory Diarrhea
Rifaximin is NOT recommended as a primary treatment for pediatric inflammatory diarrhea, as it lacks efficacy against invasive enteric pathogens that cause inflammatory/bloody diarrhea and has insufficient pediatric evidence for this indication.
FDA-Approved Pediatric Indication
Rifaximin is FDA-approved only for traveler's diarrhea in children ≥12 years of age, specifically for noninvasive strains of Escherichia coli 1. The FDA label explicitly states: "Do not use in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli" 1.
Key Limitations for Inflammatory Diarrhea
Lack of Efficacy Against Invasive Pathogens
- Rifaximin demonstrates poor activity against dysenteric/inflammatory diarrhea caused by invasive pathogens such as Campylobacter, Salmonella, and Shigella species 2, 3
- Clinical failure rates reach up to 50% when invasive pathogens are present 4
- The drug is not appropriate for treatment of dysentery, irrespective of illness severity 4
Insufficient Pediatric Evidence
- No well-designed pediatric trials exist for inflammatory diarrhea treatment 4
- The 2017 IDSA/SHEA guidelines note that rifaximin "has been used in younger children with refractory IBDs and small intestinal bacterial overgrowth with few reports of adverse events," but this represents off-label use without robust efficacy data 4
Alternative Appropriate Uses in Pediatrics
Multiply Recurrent Clostridioides difficile Infection (CDI)
Rifaximin may be considered as part of combination therapy (oral vancomycin followed by rifaximin) for pediatric patients with multiple CDI recurrences after standard treatments have failed 4. This recommendation is extrapolated from adult data, as pediatric-specific evidence is lacking 4.
Inflammatory Bowel Disease (IBD) - Limited Role
- A retrospective pediatric study (n=23) showed that 60% of children with IBD-related diarrhea experienced relief within 4 weeks when rifaximin was added at doses of 10-30 mg/kg 5
- However, the 2019 Canadian Association of Gastroenterology guidelines for pediatric Crohn's disease made no recommendation for or against antibiotics (including rifaximin) for induction or maintenance therapy due to insufficient evidence, concerns about antimicrobial resistance, and lack of pediatric safety data 4
Clinical Algorithm for Decision-Making
When evaluating a pediatric patient with diarrhea:
Assess for inflammatory features (fever, bloody stools, fecal leukocytes):
If non-inflammatory traveler's diarrhea in child ≥12 years:
If multiply recurrent CDI after standard therapy failure:
- Consider oral vancomycin followed by rifaximin based on adult evidence 4
If refractory IBD with persistent diarrhea:
Important Safety Considerations
- Rifaximin has an excellent safety profile with minimal systemic absorption (<0.4%) and few adverse events 4, 6
- Concerns exist regarding antimicrobial resistance development, though clinical significance remains unclear 4
- No serious adverse events reported in pediatric use, but long-term data are lacking 4
Common Pitfalls to Avoid
- Do not use rifaximin empirically for bloody diarrhea or when invasive pathogens are suspected—this represents treatment failure and delays appropriate therapy 4, 1
- Do not assume IBD efficacy based on small case series—the mechanism of benefit in IBD remains unclear and guidelines do not support routine use 4
- Do not use in children <12 years for traveler's diarrhea without recognizing this is off-label use 1