Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Exp… (NCT00435526) | Clinical Trial Compass
CompletedPhase 1
Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I
United States30 participantsStarted 2006-03
Plain-language summary
The purpose of this study is to assess anti-CFA/I and anti-CfaE BIgG safety and to determine protective efficacy of anti-CFA/I and anti-CfaE BIgG against diarrhea after challenge with H10407, a CFA/I-expressing ETEC strain.
Who can participate
Age range18 Years – 45 Years
SexALL
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Inclusion Criteria:
* Male or female between 18 and 45 years of age.
* General good health, without significant medical illness, abnormal physical examination findings or clinical laboratory abnormalities as determined by principal investigator.
* Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written examination (pass grade ≥ 70%)
* Willing to participate after informed consent obtained.
* Available for all planned follow-up visits.
* Negative serum pregnancy test at screening and a negative urine pregnancy test on the day of admittance to the inpatient phase for female volunteers of childbearing potential. Females of childbearing potential must agree to use an efficacious hormonal or barrier method of birth control during the study. Abstinence is acceptable. Female volunteers unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
Exclusion Criteria:
* Presence of a significant medical condition, (e.g. psychiatric conditions or gastrointestinal disease, such as peptic ulcer, symptoms or evidence of active gastritis or gastroesophageal reflux disease, inflammatory bowel disease, alcohol or illicit drug abuse/dependency), or other laboratory abnormalities which in the opinion of the investigator precludes participation in the study.
* Immunosuppressive illness or IgA deficiency (below the normal limits)
* Positive serology results for HIV, HBsAg, or HCV antibodies.
* Significant abnormalitie…
What they're measuring
1
Clinical diagnosis of diarrhea defined as 1 loose/liquid stool (≥ Grade 3) of >300 g OR ≥ 2 loose/liquid stools totaling ≥ 200 g during any 48-hour period within 120 hours of challenge with ETEC strain H10407.
Trial details
NCT IDNCT00435526
SponsorJohns Hopkins Bloomberg School of Public Health