NCT00198796

Brief Summary

Five subjects will be admitted to the General Clinical Research Center (GCRC). The next day they will eat a light breakfast, fast for 90 minutes, ingest ETEC strain H10407, and fast for 90 more minutes. After this challenge they will be monitored closely , and all stools will be collected, graded and weighed. On Day 5, or sooner if indicated, they will begin antibiotics to eradicate the challenge strain. They will be scheduled for discharge on Day 7 but may leave a few days earlier if early antibiotic treatment is given. Hypothesis: A challenge dose of 10(9) colony forming unit (CFU) of ETEC strain H10407, will cause diarrhea in at least 60% of subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

September 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2007

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

September 13, 2005

Last Update Submit

April 7, 2017

Conditions

Diarrhea

Outcome Measures

Primary Outcomes (1)

  • To validate a dose for ETEC H10407 that will cause diarrhea in 50% or more of subjects without causing high output diarrhea, as determined by stool output volumes or signs and symptoms associated with hypovolemia.

    6 months

Secondary Outcomes (1)

  • To measure mucosal and systemic immune response to the somatic and toxin antigens of the H10407 strain.

    6 months

Study Arms (1)

H10407

EXPERIMENTAL

H10407

Biological: H10407

Interventions

H10407BIOLOGICAL

The primary objective of the proposed clinical investigation is to validate a dose for ETEC H10407 that will cause diarrhea in 50% or more of subjects without causing high output diarrhea

Also known as: Experimental
H10407

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults age 18 to 45 years old who are willing to participate, complete training on ETEC and diarrhea and procedures of the protocol, pass the test documenting knowledge of the study, and give informed consent.

You may not qualify if:

  • age\<18 or \>45 years
  • Chronic illness, chemical dependency, or significant medical illness as determined by the investigator.
  • immunosuppressive condition or IgA (Immunoglobulin A) deficiency
  • HIV antibody positive
  • hepatitis B surface antigen positive
  • hepatitis C antibody positive
  • travel to ETEC endemic area within 2 years
  • vaccination or other exposure to ETEC, cholera, or heat labile toxin (LT) toxin within 3 years
  • pregnancy as defined by + serum or urine - human chorionic gonadotropin (HCG) on the day before immunization
  • inability to pass the written examination
  • use of antibiotic, H2 blocking agent or proton pump inhibitor within 7 days of challenge
  • regular use of laxatives antacids or other agents to lower stomach acidity
  • significant abnormality in screening lav hematology and chemistry tests as determined by the investigator.
  • significant abnormality on EKG for those 40 to 50 years old as determined by the investigator.
  • allergy to quinolones, penicillin's and Bactrim.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Clinical Research Center

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robin McKenzie, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: We will initially study the effects of a 1x109 dose of H10407 (in 5 subjects) and then proceed to the dose-finding portion of the trial to study the effects of low (5x108) or higher doses (5x109) of the CS17 expressing strains (total of 20 subjects)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

February 22, 2007

Study Completion

May 30, 2007

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)