Nitazoxanide vs Metronidazole for Entamoeba Diarrhea in Children

NCT07790926 | Completed Phase 2 DMC

• 1 other identifier: CHL-IRB-716
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Entamoeba Histolytica Diarrhea

Keywords

Entamoeba histolytica; Amebic diarrhea; Nitazoxanide; Metronidazole; Pediatric diarrhea

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 5 after initiation of treatment

Secondary Outcomes (1)

• Duration of hospital stay

  From hospital admission until discharge, assessed up to 5 days after initiation of treatment

Study Arms (2)

Nitazoxanide Group

EXPERIMENTAL

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

Metronidazole Group

ACTIVE COMPARATOR

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

Interventions

Nitazoxanide DRUG

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

Nitazoxanide Group

Metronidazole DRUG

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.

Metronidazole Group

Eligibility Criteria

• Age: 2 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of both genders aged between 2 to 15 years having diarrhea (frequency of stools greater than 3 or stools softer than normal consistency with nausea, abdominal cramps.
• Children having Entamoema infection proven on microscopic examination by presence of cyst and trophozite of entamoeba

You may not qualify if:

• Patient with severe dehydration. Patient with any serious concomitant illness that needs antibiotic treatment. If severe adverse events occur at any time. Cytotoxic drugs, food \& chemical poisoning Those who were not able to attend follow-up examinations Children suffering from any other systemic disorders like PEM, certain Immunodeficiencies and Cystic Fibrosis.
• Microscopic stool examination positive to cyst of Entamoeba histolytica.

Sponsors & Collaborators

• University of Child Health Sciences and Children's Hospital, Lahore: lead

Study Sites (1)

Department of Pediatric Medicine

Lahore, Punjab Province, 54100, Pakistan

Location

Related Publications (1)

• Bauhofer, A.F.L., Cossa-Moiane, I., Marques, S., Guimaraes, E.L., Munlela, B., Anapakala, E., Chilaúle, J.J., Cassocera, M., Langa, J.S., Chissaque, A. and Sambo, J. (2020) 'Intestinal infections among children 0-168 months with diarrhea in Mozambique: June 2019-January 2018', PLoS Neglected Tropical Diseases, 14(4), e0008195. Firdu, T., Abunna, F. and Girma, M. (2014) 'Intestinal protozoal parasites in diarrheal children and associated risk factors at Yirgalem Hospital, Ethiopia: A case-control study', International Scholarly Research Notices, 2014, Article ID 357126, pp. 1-8. Ngosso, M.M., Nkwengulila, G. and Namkinga, L.A. (2015) 'Prevalence of intestinal parasites among school children in Tanzania', African Health Sciences, 15(3), pp. 782-789. Ali, A.A.E., Abdelrahim, M.E.A., Elmoslamy, N.A., Said, A.S.A. and Meabed, M.H. (2014) 'Comparison between nitazoxanide and metronidazole in the treatment of protozoal diarrhea in children', Medicine Science, 3(2), pp. 1162-1173. Haq, S.U., Mehmood, A., Haq, Z.U., Ali, S., Liaquat, I. and Hussain, M. (2022) 'To compare the efficacy of 3 days treatment with Nitazoxanide vs 5 days treatment with Metronidazole in treating children with diarrhea caused by Giardia-lamblia', The Professional Medical Journal, 29(5), pp. 676-680. Irfan, M., Najeeb, S., Raza Shah, M.K., Jamil, M.S., Iftikhar, N. and Sultan, A.N. (2023) 'Evaluation of Nitazoxanide versus Metronidazole in Pediatric Giardia lamblia-Induced Diarrhea: A Comparative Efficacy Analysis', Annals of Punjab Medical College, 17(4), pp. 570-573. doi:10.29054/apmc/2023.1435. Abo-Sheishaa, E.E., Khedher, A.S. and Nasr, F. (2016) 'Molecular characterization of Entamoeba histolytica and its correlation with clinical manifestations of amoebic dysentery', International Journal of Infectious Diseases, 50, pp. 50-56. doi:10.1016/j.ijid.2016.07.024. Adnan, A., Jamshaid, A.A., Farooq, M.A. and Fatima, T. (2021) 'Nitazoxanide in treatment of rotavirus diarrhea in children: A single center

  RESULT

MeSH Terms

Interventions

nitazoxanide; Metronidazole

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label randomized controlled trial. Participants, treating physicians, study staff, and outcome assessors are not masked to the assigned treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Participants are randomly assigned to one of two parallel treatment groups. Group A receives nitazoxanide, while Group B receives metronidazole. Each participant receives only the assigned treatment.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start: April 2, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)