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

Al-Azhar University

Status and phase: Enrolling; Phase 2

Conditions: Cryptosporidium Infection

Treatments: Drug: Echinacea Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07388615

IN000190

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

interventional arm

Active Comparator group

Treatment:

Drug: Echinacea Extract