Entamoeba Histolytica DiarrheaPhase 2NIT METNCT07790926
Nitazoxanide vs Metronidazole for Entamoeba Diarrhea in Children
A Phase 2 study testing Nitazoxanide and Metronidazole in people with Entamoeba Histolytica Diarrhea, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- Entamoeba Histolytica Diarrhea
- What is being tested?
- Nitazoxanide and Metronidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Apr 2024to 1 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pediatric Medicine
Lahore, Punjab Province, 54100
About this study
Official title: Comparison Between Nitazoxanide and Metronidazole in Treatment of Diarrhea Caused by Entamoeba in Children
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Entamoeba Histolytica Diarrhea
- Being tested
- Nitazoxanide, Metronidazole
- Keywords
- Entamoeba histolytica, Amebic diarrhea, Nitazoxanide, Metronidazole, Pediatric diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NitazoxanideDrug
Also called NTZ
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.
MetronidazoleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Metronidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 5 after initiation of treatment
Secondary outcomes (1)
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.
Measured: From hospital admission until discharge, assessed up to 5 days after initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start2 Apr 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Entamoeba Histolytica DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulzar Fatima, University of Child Health Sciences and Children's Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790926
- Sponsor's protocol ID
- CHL-IRB-716
- Acronym
- NIT MET
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Nitazoxanide and Metronidazole in Treatment of Diarrhea Caused by Entamoeba in Children
- ClinicalTrials.gov ID
- NCT07790926
- Acronym / sponsor ID
- NIT MET / CHL-IRB-716
- Conditions
- Entamoeba Histolytica Diarrhea
- Keywords
- Entamoeba histolytica, Amebic diarrhea, Nitazoxanide, Metronidazole, Pediatric diarrhea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Nitazoxanide Group | Experimental | Drug: NitazoxanideChildren 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. |
| Metronidazole Group | Active comparator | Drug: MetronidazoleChildren 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. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NitazoxanideAlso: NTZNitazoxanide 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. | Drug | Nitazoxanide Group |
| MetronidazoleMetronidazole 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. | Drug | Metronidazole Group |
Primary outcome
Treatment efficacy
Time frame: Day 5 after initiation of treatment
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.
1 secondary outcome
Duration of hospital stay
Time frame: From hospital admission until discharge, assessed up to 5 days after initiation of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Results publicationBauhofer, 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
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nitazoxanide and Metronidazole in people with Entamoeba Histolytica Diarrhea, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy (time frame: Day 5 after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07790926, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.