What is the evidence-based role of Nitazoxanide (NTZ) in pediatric diarrhea?

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Last updated: February 22, 2025View editorial policy

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From the Guidelines

Nitazoxanide is recommended as an effective treatment for pediatric diarrhea, particularly in cases caused by Cryptosporidium and Giardia, as stated in the 2017 Infectious Diseases Society of America clinical practice guidelines for the diagnosis and management of infectious diarrhea 1.

Key Points

  • The guidelines recommend Nitazoxanide for the treatment of Cryptosporidium and Giardia infections in pediatric patients.
  • The medication is available as an oral suspension or tablet and should be taken with food to increase absorption.
  • Dosage for children:
    • 1-3 years old: 100 mg every 12 hours for 3 days
    • 4-11 years old: 200 mg every 12 hours for 3 days
    • 12 years and older: 500 mg every 12 hours for 3 days
  • Nitazoxanide works by interfering with the anaerobic energy metabolism of parasites, effectively killing them, and has shown efficacy against a broad spectrum of parasites, bacteria, and viruses that cause diarrhea in children.

Considerations

  • While generally well-tolerated, common side effects may include abdominal pain, headache, and nausea.
  • It's essential to complete the full course of treatment even if symptoms improve before finishing the medication.
  • Nitazoxanide should be considered alongside proper hydration and other supportive care measures for managing pediatric diarrhea, as recommended by the 2017 Infectious Diseases Society of America clinical practice guidelines 1.
  • In areas with high prevalence of parasitic infections, Nitazoxanide can be a valuable first-line treatment option.

Additional Recommendations

  • Oral zinc supplementation can reduce the duration of diarrhea in children 6 months to 5 years of age who reside in countries with a high prevalence of zinc deficiency or who have signs of malnutrition, as stated in the 2017 Infectious Diseases Society of America clinical practice guidelines 1.

From the FDA Drug Label

Diarrhea caused by C parvum in pediatric patients 1 through 11 years of age : In two double-blind, controlled trials in pediatric patients with diarrhea and with or without enteric symptoms (e.g., abdominal distention, colic, left iliac fossa tenderness) caused by C. parvum, a three-day course of treatment with nitazoxanide (100 mg twice daily in pediatric patients ages 12-47 months, 200 mg twice daily in pediatric patients ages 4 through 11 years) was compared with a placebo. The following clinical response rates were obtained: Table 7 Clinical Response Rates in Pediatric Patients 3 to 7 Days Post-therapy Intent-to-Treat Analyses % (Number of Successes/Total) Population Nitazoxanide* Placebo Outpatient Study, age 1 - 11 years 88% (21/24) 38% (9/24) Inpatient Study, Malnourished ¶, age 12-35 months 56% (14/25) 23% (5/22 )

  • Clinical response rates statistically significantly higher compared to placebo

The evidence-based role of Nitazoxanide (NTZ) in pediatric diarrhea is that it is effective in treating diarrhea caused by C. parvum in pediatric patients 1 through 11 years of age, with clinical response rates statistically significantly higher compared to placebo 2.

  • Key findings:
    • Outpatient study: 88% response rate with NTZ vs 38% with placebo
    • Inpatient study in malnourished patients: 56% response rate with NTZ vs 23% with placebo
  • Recommended dosage: 100 mg twice daily in pediatric patients ages 12-47 months, 200 mg twice daily in pediatric patients ages 4 through 11 years.

From the Research

Efficacy of Nitazoxanide in Pediatric Diarrhea

  • Nitazoxanide has been shown to be effective in reducing the duration of diarrheal illness in children, with a median time to resolution of symptoms of 23 hours compared to 103.5 hours for placebo 3.
  • The drug has been found to be effective against multiple etiologies, including Giardia lamblia and Cryptosporidium parvum, as well as in patients with no identified enteropathogen 3, 4.
  • Nitazoxanide has also been shown to be effective in the treatment of persistent diarrhea in children, with a success rate of 84% for protozoa and 95% for helminths 5.

Comparison with Other Treatments

  • Nitazoxanide has been compared to probiotics in the treatment of acute rotavirus diarrhea in children, with both treatments showing a significant reduction in the duration of diarrhea and hospitalization compared to oral rehydration solution alone 6.
  • Nitazoxanide has been found to be a viable therapeutic option for the empiric treatment of diarrheal illness in children where the etiology is unknown or presumed to be of infectious origin 3, 7.

Safety and Tolerance

  • Nitazoxanide has been found to be well tolerated in children, with no serious adverse effects reported in several studies 3, 5.
  • The drug has been shown to be safe and effective in children as young as 2 years old, with a good pharmacokinetic profile 4, 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Nitazoxanide for the empiric treatment of pediatric infectious diarrhea.

Transactions of the Royal Society of Tropical Medicine and Hygiene, 2012

Research

Epidemiology and control of intestinal parasites with nitazoxanide in children in Mexico.

The American journal of tropical medicine and hygiene, 2003

Research

Nitazoxanide vs. probiotics for the treatment of acute rotavirus diarrhea in children: a randomized, single-blind, controlled trial in Bolivian children.

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases, 2009

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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