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Recruiting NCT07388615

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

Phase II Interventional Cryptosporidium Infection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Echinacea Extract.
Who it may be relevant to
Registry conditions: Cryptosporidium Infection. Basic parameters: 5 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

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.

Interventions

  • Drug Echinacea Extract
    Immulant ® (an extract derived from Echinacea purpurea plant)

Primary outcome measures

  • To measure the changes in parasite count in stool samples after treatment [Time frame: six months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • National Nutritional Institute — Cairo

Identifiers

NCT: NCT07388615 · IN000190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗