The Effect of Echinacea (Immulant ®) in the Treatment of... | NCT07388615

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

NCT07388615

Sponsor

Al-Azhar University

Status

Recruiting

Last Update Posted

Feb 5, 2026Actual

Enrollment

60Estimated

Phase

Phase 2

Conditions

Cryptosporidium Infection

Interventions

Echinacea Extract

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 18, 2026Estimated

Primary Completion Date

Jun 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

Jan 18, 2026

First Submission Date that Met QC Criteria

Jan 28, 2026

First Posted Date

Feb 5, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2026

Last Update Posted Date

Feb 5, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
interventional arm	Active Comparator		Drug: Echinacea Extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echinacea Extract	Drug	Immulant ® (an extract derived from Echinacea purpurea plant)	interventional arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Salah	Contact	02+01147491425		majy3000vip@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Nutritional Institute	Recruiting	Cairo		11731	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D003457	Cryptosporidiosis

Ancestor Terms

ID	Term
D007411	Intestinal Diseases, Parasitic
D010272	Parasitic Diseases
D007239	Infections
D011529	Protozoan Infections, Animal

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000718679	Echinacea extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided