The Effect of Echinacea (Immulant ®) in the Treatment of CRYPTOSPORIDIOSIS in Immunocompromised Children

January 28, 2026 updated by: Maha Abd Elrhman, Al-Azhar University

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. To assess the safety and tolerability of Immulant ® in children participating in the study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt, 11731
        • Recruiting
        • National Nutritional Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of Cryptosporidiosis Disease
  • Age from 5-12 years
  • Immunocompromised children
  • Not receiving any drugs causing immunosuppression

Exclusion Criteria:

  • Patients undergoing organ transplantation
  • Patients suffering from autoimmune diseases.
  • Patients suffering from hypersensitivity of this plant extract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: interventional arm
Drug: Echinacea Extract
Immulant ® (an extract derived from Echinacea purpurea plant)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To measure the changes in parasite count in stool samples after treatment
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 18, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 5, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IN000190

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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