A Phase 2 interventional study of Nitazoxanide and Metronidazole in Entamoeba Histolytica Diarrhea, sponsored by University of Child Health Sciences and Children's Hospital, Lahore. Completed at 1 site in Pakistan. Open to participants aged 2 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by University of Child Health Sciences and Children's Hospital, Lahore · Phase 2, Interventional, and Treatment
This randomized controlled trial is comparing two medicines, nitazoxanide and metronidazole, for the treatment of diarrhea caused by Entamoeba histolytica in children. The study is being conducted in the Department of Pediatric Medicine at The Children's Hospital \& The Institute of Child Health Sciences, Lahore.
A total of 90 children with diarrhea caused by Entamoeba histolytica are included in the study. Participants are randomly assigned to one of two treatment groups. One group receives nitazoxanide, while the other group receives metronidazole. Nitazoxanide is given according to the child's age for 3 days, while metronidazole is given according to body weight for 5 days.
The main purpose of the study is to compare how effective the two medicines are in improving diarrhea. Treatment effectiveness is assessed by reduction in stool frequency to three or fewer stools per day and improvement to normal stool consistency. Participants are also assessed for duration of hospital stay and other clinical characteristics. Stool samples are examined after treatment to assess for the presence of Entamoeba cysts or trophozoites.
The study aims to determine whether nitazoxanide or metronidazole provides better treatment outcomes in children with Entamoeba histolytica diarrhea.
ntamoeba histolytica is an important cause of intestinal infection and diarrhea in children. Management of amebic diarrhea commonly involves antimicrobial therapy, with metronidazole being a conventional treatment option. Nitazoxanide is another antimicrobial agent that has been used for intestinal parasitic infections. However, comparative evidence regarding their effectiveness in children with Entamoeba histolytica diarrhea remains limited and inconsistent. This randomized controlled trial was conducted to compare the effectiveness of nitazoxanide with metronidazole in children with diarrhea caused by Entamoeba histolytica.
The study was conducted in the Department of Pediatric Medicine, The Children's Hospital \& The Institute of Child Health Sciences, Lahore. After approval from the Hospital's Ethical Review Board, children fulfilling the study selection criteria were enrolled. A total of 90 participants were included and randomly allocated into two treatment groups using a lottery method, with 45 participants in each group. Written informed consent was obtained from the parents of the participating children.
Participants underwent detailed history taking, clinical examination, and relevant laboratory assessment. Children with Entamoeba infection were identified through microscopic examination of stool samples for the presence of cysts or trophozoites. Children with severe dehydration, serious concomitant illness requiring antibiotic treatment, severe adverse events, inability to attend follow-up, or specified systemic disorders were excluded from the study.
Participants allocated to the nitazoxanide group received nitazoxanide according to age, while those allocated to the metronidazole group received metronidazole according to body weight. The treatment groups were followed clinically, and information regarding treatment response and clinical outcomes was recorded. Stool samples were collected after completion of therapy and examined microscopically. Clinical assessment was performed by the same consultant pediatrician to maintain consistency in patient assessment and reduce observer-related variation.
The principal treatment outcome was effectiveness, assessed by improvement in diarrheal symptoms, specifically reduction of stool frequency to three or fewer stools per day together with normal stool consistency after treatment. Duration of hospital stay was also assessed as an additional clinical outcome. The study further examined whether treatment effectiveness differed according to selected participant characteristics, including age, gender, stool frequency, diarrhea type, and stool consistency.
Data were analyzed using SPSS version 26. Numerical variables were summarized using mean and standard deviation, while categorical variables were presented as frequencies and percentages. The Chi-square test was used to compare treatment effectiveness between the two groups, and the independent-samples t-test was used to compare mean duration of hospital stay. Stratified analyses were performed for selected variables to assess potential effect modification. A p-value of ≤0.05 was considered statistically significant.
The study included 90 children with a mean age of 6.87 ± 3.28 years. The overall treatment response was higher among participants receiving nitazoxanide than among those receiving metronidazole. In the nitazoxanide group, 41 of 45 participants (91.1%) demonstrated treatment effectiveness, compared with 33 of 45 participants (73.2%) in the metronidazole group, with a statistically significant difference (p=0.040). The mean duration of hospital stay was also shorter in the nitazoxanide group (3.55 ± 1.249 days) than in the metronidazole group (4.57 ± 1.661 days), with a statistically significant difference (p\<0.001).
Overall, the findings of the study indicate that nitazoxanide demonstrated a higher treatment effectiveness and shorter hospital stay compared with metronidazole in the studied pediatric population with Entamoeba histolytica diarrhea.
Children having Entamoema infection proven on microscopic examination by presence of cyst and trophozite of entamoeba
Exclusion Criteria:
Microscopic stool examination positive to cyst of Entamoeba histolytica.
Children randomized to this group will receive oral nitazoxanide as the study intervention. Children aged 2-3 years will receive 100 mg twice daily for 3 days, while children aged 4-11 years will receive 200 mg twice daily for 3 days. Treatment will be administered according to the assigned study protocol, with clinical assessment during treatment and follow-up.
Drug: Nitazoxanide
Children randomized to this group will receive oral metronidazole as the active comparator treatment for 5 days. The drug will be administered according to the assigned study protocol, with clinical assessment during treatment and follow-up. Treatment efficacy will be assessed based on reduction of diarrheal episodes to three or fewer stools per day and improvement toward normal stool consistency.
Drug: Metronidazole
Nitazoxanide will be administered orally twice daily for 3 days. Children aged 2-3 years will receive 100 mg per dose, while children aged 4-11 years will receive 200 mg per dose. Treatment will be provided to participants randomized to the nitazoxanide group, with clinical assessment during treatment and follow-up to evaluate treatment efficacy and resolution of diarrhea.
Also known as: NTZ
Metronidazole will be administered orally to children diagnosed with Entamoeba histolytica-associated diarrhea. The drug will be given at the recommended pediatric dose according to the child's age and body weight, divided into appropriate daily doses for the prescribed treatment duration. It will serve as the active comparator treatment in the study. Treatment response will be assessed based on clinical improvement, including resolution of diarrhea and other associated symptoms, and compared with the nitazoxanide group.
Treatment efficacy
Treatment efficacy will be assessed by clinical resolution of diarrhea, defined as reduction in diarrheal episodes to three or fewer stools per day together with improvement of stool consistency toward normal after completion of treatment.
Time frame: Day 5 after initiation of treatment
Duration of hospital stay
Duration of hospital stay will be measured as the total number of days from admission to discharge and compared between the nitazoxanide and metronidazole groups.
Time frame: From hospital admission until discharge, assessed up to 5 days after initiation of treatment
Plan to share: No — Individual participant-level data will not be shared with other researchers. The study data will be used for the purposes of the present research and will be maintained securely by the research team in accordance with institutional ethical and confidentiality requirements.
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University of Child Health Sciences and Children's Hospital, Lahore