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Virus Therapy

ETEC strain for Traveler's diarrhea

N/A
Recruiting
Research Sponsored by Scandinavian Biopharma AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 hours post-challenge
Awards & highlights

Study Summary

This trial will track how many people develop moderate to severe diarrhea after being given a specific strain of E. coli bacteria. The goal is to gather data for a future study on the effectiveness of an oral

Who is the study for?
This trial is for healthy adults who can travel to the research center in Baltimore. Participants should not have any known immunity or previous exposure to ETEC strains, and they must be willing to follow study procedures like consuming the ETEC strain and staying at the facility.Check my eligibility
What is being tested?
The study is testing how often moderate to severe diarrhea occurs after taking a specific strain of Enterotoxigenic E. coli (ETEC). This will help verify the right dose for future trials on an oral vaccine against this type of bacteria that causes traveler's diarrhea.See study design
What are the potential side effects?
Since participants will be exposed to an ETEC strain, expected side effects include symptoms of traveler's diarrhea such as loose stools, abdominal cramps, nausea, vomiting, fever, and dehydration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 hours post-challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 hours post-challenge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The incidence of moderate and severe diarrhea

Trial Design

1Treatment groups
Experimental Treatment
Group I: ETEC strainExperimental Treatment1 Intervention
Each enrolled subject will receive a single administration of the challenge dose

Find a Location

Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthOTHER
410 Previous Clinical Trials
2,106,900 Total Patients Enrolled
Scandinavian Biopharma ABLead Sponsor
4 Previous Clinical Trials
8,332 Total Patients Enrolled

Frequently Asked Questions

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

Is the enrollment for this medical study limited to individuals who are 35 years old and above?

"Recruitment for this research study targets individuals aged 18 to under 50 years old."

Answered by AI

Are there still available slots for patients to participate in this ongoing clinical trial?

"As per the details available on clinicaltrials.gov, this study is presently in search of eligible participants. The trial was initially listed on 2/12/2024 and underwent its most recent update on 3/1/2024."

Answered by AI

How many individuals in total are enrolled in this research project?

"Affirmative. The details available on clinicaltrials.gov indicate that this specific medical trial is actively seeking participants. Initial posting of the trial occurred on February 12, 2024, with subsequent updates made as recent as March 1, 2024. This investigation aims to enroll a total of 30 patients at one designated site."

Answered by AI
~10 spots leftby Jun 2024