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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.

  • 2025-03-12
  • BMC pediatrics 25(1)
    • Behrooz Heydari
    • Majid Aflatonian
    • Mina Bagherizadeh
    • Farahnaz Hoseinzade
    • Fatemeh Saghafi

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 71
Population
71 patients, confirmed to have gastroenteritis resulting from rotavirus using a rapid diagnostic strip
Methods
Double-blind clinical trial, randomly allocated to two groups, NAC at 60 mg/kg/day vs placebo
Blinding
Double-blind
Duration
daily until gastroenteritis improved
Funding
Unclear

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 ).

Research Insights

  • N-Acetyl Cysteine→Improved Bowel Movement Frequency

    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.

    Effect
    Neutral
    Effect size
    Small
    Dose
    60 mg/kg/day
  • N-Acetyl Cysteine→Reduced Diarrhea Rate

    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.

    Effect
    Neutral
    Effect size
    Small
    Dose
    60 mg/kg/day
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