Evaluating the efficacy of N-acetylcysteine in diminishing the duration and frequency of rotavirus-induced gastroenteritis: a preliminary randomized, placebo-controlled, double-blind clinical trial

BMC Pediatr. 2025 Mar 12;25(1):186. doi: 10.1186/s12887-025-05534-7.

Abstract

Background: Globally, gastroenteritis stands as a primary contributor to child mortality, annually taking the lives of 3 million children under the age of 5 years. Rotavirus, a major factor in viral diarrhea among children aged 6 months to 2 years, presents with severe symptoms such as watery diarrhea and vomiting. Although mortality rates have decreased due to supportive care and vaccines, promising alternatives like N-acetylcysteine (NAC) show potential benefits in laboratory studies, indicating a possible supplementary strategy for managing rotavirus infections by reducing the duration and antigen excretion in feces.

Methods: During this double-blind clinical trial, 71 patients, confirmed to have gastroenteritis resulting from rotavirus using a rapid diagnostic strip, were randomly allocated to two groups. One group was prescribed NAC at a dosage of 60 mg/kg/day, while the other received a placebo. The patient's progress was monitored daily until their gastroenteritis improved, and details regarding the duration of diarrhea and the frequency of bowel movements were recorded for each participant.

Results: The average duration of diarrhea in the NAC group and the placebo group was 2 and 3 days, respectively, with a level of p = 0.121. During the diarrhea period, the number of bowel movements in the NAC group was recorded at 28.1 ± 21.6 times, whereas in the placebo group, it was 35.3 ± 33.1 times, yielding a p-value of 0.409.

Conclusions: Even though the effects of NAC were observed in lowering the duration of the period and decreasing the frequency of bowel movements in gastroenteritis, these results did not reach statistical significance. Hence, the data from this study suggest that NAC may not effectively reduce the duration of diarrhea and the frequency of bowel movements linked to gastroenteritis caused by rotavirus.

Trial registration: IRCT20181208041882N13, 14-10-2023 ( https://irct.behdasht.gov.ir/trial/68259 ).

Keywords: Children; Clinical trial; Diarrhea; Gastroenteritis; N-acetylcysteine; Rotavirus.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetylcysteine* / therapeutic use
  • Child, Preschool
  • Diarrhea* / drug therapy
  • Diarrhea* / etiology
  • Double-Blind Method
  • Female
  • Gastroenteritis* / complications
  • Gastroenteritis* / drug therapy
  • Gastroenteritis* / virology
  • Humans
  • Infant
  • Male
  • Rotavirus
  • Rotavirus Infections* / complications
  • Rotavirus Infections* / drug therapy
  • Time Factors
  • Treatment Outcome

Substances

  • Acetylcysteine