Cryptosporidium InfectionPhase 2NCT07388615
The Effect of Echinacea (Immulant ®) in the Treatment of CRYPTOSPORIDIOSIS in Immunocompromised Children
A Phase 2 study testing Echinacea Extract in people with Cryptosporidium Infection, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This study aims to: 1. To evaluate the effectiveness of Immulant ® addition to standard treatment in reducing clinical symptoms of Cryptosporidiosis in immunocompromised children. 2. To measure the changes in parasite count in stool samples after treatment with Immulant ®. 3. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Cryptosporidium Infection
- What is being tested?
- Echinacea Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Jan 2026to Aug 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical diagnosis of Cryptosporidiosis Disease
- Age from 5-12 years
- Immunocompromised children
- Not receiving any drugs causing immunosuppression
Who cannot join
- Patients undergoing organ transplantation
- Patients suffering from autoimmune diseases.
- Patients suffering from hypersensitivity of this plant extract
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
National Nutritional Institute
Cairo, 11731
National Nutritional Institute, 02-01147491425, majy3000vip@gmail.com
About this study
This study aims to:
- To evaluate the effectiveness of Immulant ® addition to standard treatment in reducing clinical symptoms of Cryptosporidiosis in immunocompromised children.
- To measure the changes in parasite count in stool samples after treatment with Immulant ®.
- To assess the safety and tolerability of Immulant ® in children participating in the study.
Read the detailed description
The present prospective study will be (open labelled) Randomized Clinical Trial and was approved by the Research Ethical Committee Of national nutritional institute. Oral and written consent will be obtained from all patients and controls after a full explanation of the study.
A total of at least 60 immunocompromised children consecutively diagnosed with cryptosporidiosis were recruited from the outpatient clinic of National Nutritional Institute.
- Conditions
- Cryptosporidium Infection
- Being tested
- Echinacea Extract
- Medical subject headings
- Cryptosporidiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinacea ExtractDrug
Immulant ® (an extract derived from Echinacea purpurea plant)
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Active comparator | Not described Receives: Drug: Echinacea Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the changes in parasite count in stool samples after treatment
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start18 Jan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptosporidium InfectionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- open labelled randomized controlled
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Abd Elrhman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07388615
- Sponsor's protocol ID
- IN000190
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Echinacea (Immulant ®) in the Treatment of CRYPTOSPORIDIOSIS in Immunocompromised Children
- ClinicalTrials.gov ID
- NCT07388615
- Acronym / sponsor ID
- IN000190
- Conditions
- Cryptosporidium Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 18 Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 5 Feb 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 study aims to:
- To evaluate the effectiveness of Immulant ® addition to standard treatment in reducing clinical symptoms of Cryptosporidiosis in immunocompromised children.
- To measure the changes in parasite count in stool samples after treatment with Immulant ®.
- To assess the safety and tolerability of Immulant ® in children participating in the study.
Detailed description
The present prospective study will be (open labelled) Randomized Clinical Trial and was approved by the Research Ethical Committee Of national nutritional institute. Oral and written consent will be obtained from all patients and controls after a full explanation of the study.
A total of at least 60 immunocompromised children consecutively diagnosed with cryptosporidiosis were recruited from the outpatient clinic of National Nutritional Institute.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- open labelled randomized controlled
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Active comparator | Drug: Echinacea Extract |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Clinical diagnosis of Cryptosporidiosis Disease
- Age from 5-12 years
- Immunocompromised children
- Not receiving any drugs causing immunosuppression
Key exclusion criteria (3 listed)
- Patients undergoing organ transplantation
- Patients suffering from autoimmune diseases.
- Patients suffering from hypersensitivity of this plant extract
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 |
|---|---|---|
| Echinacea ExtractImmulant ® (an extract derived from Echinacea purpurea plant) | Drug | interventional arm |
Primary outcome
To measure the changes in parasite count in stool samples after treatment
Time frame: six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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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.
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 Echinacea Extract in people with Cryptosporidium Infection, run by Al-Azhar University at 1 site in Egypt.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salah (02+01147491425, majy3000vip@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure the changes in parasite count in stool samples after treatment (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2026.