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Virus Therapy

Cryptosporidium parvum oocysts (ABO809) for Cryptosporidiosis

Phase 1
Waitlist Available
Led By Mohamed Al-Ibrahim
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Demonstrated understanding of Cryptosporidium disease, safety measures and transmission risks
Good health
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 28 up to 12 months after abo809 administration
Awards & highlights

Study Summary

This trial will test if a specific kind of Cryptosporidium causes diarrhea in humans, by giving it to them and seeing if they get sick.

Eligible Conditions
  • Cryptosporidiosis

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 28 up to 12 months after abo809 administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 28 up to 12 months after abo809 administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with cryptosporidium infection from 72 hours to 10 Days post ABO809 oral administration
Secondary outcome measures
Grading of stool consistency
Number of adverse events of special interest (AESIs) by telephone follow-up after Day 28 visit through 12 months post ABO809 oral administration
Number of diarrhea episodes per participant
+9 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABO809Experimental Treatment1 Intervention
Participants will receive ABO809 at a single oral dose of 1x10^4 oocysts. Other doses such as 1x10^6 oocysts may be considered to optimize the model
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryptosporidium parvum oocysts (ABO809)
2022
Completed Phase 1
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,559 Total Patients Enrolled
Mohamed Al-IbrahimPrincipal InvestigatorPharmaron CPC, Inc.
1 Previous Clinical Trials
24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies in this clinical trial?

"As per the information currently available on clinicaltrials.gov, this medical study is not accepting participants at present. The trial was initially posted in April of 2022 and last updated November 4th 2022; however, there are presently 772 other studies that have open enrollment policies."

Answered by AI

Does the study have an age restriction and, if so, who can qualify?

"Patients who are of legal age and younger than 50 years old can take part in this medical trial."

Answered by AI

What are the criteria for participation in this research endeavor?

"To meet the criteria of this trial, potential participants must suffer from cryptosporidiosis and be between 18 to 50 years old. Upwards of 30 individuals will have the opportunity to join this experiment."

Answered by AI

Has the ABO809 strain of Cryptosporidium parvum oocysts been sanctioned by the FDA?

"As this is a Phase 1 trial, with scarce evidence to support its safety or efficacy, Cryptosporidium parvum oocysts (ABO809) was assigned an initial score of one."

Answered by AI
~10 spots leftby Mar 2025