NCT07388615

Brief Summary

This study aims to:

  1. 1.To evaluate the effectiveness of Immulant ® addition to standard treatment in reducing clinical symptoms of Cryptosporidiosis in immunocompromised children.
  2. 2.To measure the changes in parasite count in stool samples after treatment with Immulant ®.
  3. 3.To assess the safety and tolerability of Immulant ® in children participating in the study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
3mo left

Started Jan 2026

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Jan 2026Aug 2026

First Submitted

Initial submission to the registry

January 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 18, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 18, 2026

Last Update Submit

January 28, 2026

Conditions

Cryptosporidium Infection

Outcome Measures

Primary Outcomes (1)

  • To measure the changes in parasite count in stool samples after treatment

    six months

Study Arms (1)

interventional arm

ACTIVE COMPARATOR
Drug: Echinacea Extract

Interventions

Echinacea ExtractDRUG

Immulant ® (an extract derived from Echinacea purpurea plant)

interventional arm

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutritional Institute

Cairo, 11731, Egypt

RECRUITING

MeSH Terms

Conditions

Cryptosporidiosis

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

Intestinal Diseases, ParasiticParasitic DiseasesInfectionsProtozoan Infections, AnimalParasitic Diseases, AnimalCoccidiosisProtozoan InfectionsIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAnimal Diseases

Central Study Contacts

Salah

CONTACT

02+01147491425majy3000vip@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: open labelled randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 18, 2026

First Posted

February 5, 2026

Study Start

January 18, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01

Locations

EG(1)