DiarrheaPhase 1BIgGINCT00435526
Efficacy of Anti-CFA/I and CfaE Bovine Milk Immunoglobulin Against Challenge With H10407 ETEC Expressing CFA/I
A Phase 1 study testing anti-CFA/I bovine IgG, and anti-CfaE bovine IgG in people with Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- anti-CFA/I bovine IgG, and anti-CfaE bovine IgG
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Oct 2006
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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 abnormalities in screening lab hematology, serum chemistry, urinalysis or EKG (EKG in volunteers ≥ 40 years), as determined by PI.
- Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to two of three).
- Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis.
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- History of diarrhea in the 2 weeks prior to planned inpatient phase
- Regular use of laxatives, antacids, or other agents to lower stomach acidity (regular defined as at least weekly).
- Use of antibiotics during the 7 days before dosing or proton pump inhibitors, H2 blockers, or antacids within 48 hours of dosing.
- Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within two years prior to dosing.
- History of vaccination for or ingestion of ETEC, cholera, or LT toxin.
- Stool culture (collected no more than 1 week prior to admission) positive for CFA/I + ETEC or other bacterial enteric pathogens (Salmonella, Shigella and Campylobacter).
- Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of test article, or planned use during the active study period.
- Clinical history of lactose intolerance or allergy to milk or milk products.
- Use of any medication known to affect the immune function (e.g., corticosteroids and others) within 30 days preceding the first dose of study vaccine, or planned use during the active study period.
- Inability to tolerate an over-the-counter, lactose-free, infant, powder formula suspended in 150 mL sodium bicarbonate buffer (based on requirement for frequent dosing).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Bayview Medicial Center, Inpatient Unit
Baltimore, Maryland, 21224
General Clinical Research Center
Baltimore, Maryland, 21287
About this study
Official title: Protective Efficacy of Orally Delivered Bovine Milk Immunoglobulin (BIgG) Specific for the Minor CFA/I Fimbrial Adhesin CfaE Against Challenge With H10407 Enterotoxigenic E. Coli (ETEC) Strain Expressing CFA/I
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.
Read the detailed description
This is a Randomized, double-blinded, placebo-controlled trial involving up to 33 subjects. Subjects will be randomized into one of the following three groups.
Group N Product
- 10 BIgG anti-CFA/I
- 10 BIgG anti-CfaE
- 10 LactoFree® Lipil®
Volunteers will receive the test article three times daily following meals beginning 2 days prior to oral ETEC challenge (strain H10407). Test article will be administered for a total of 7 days. Monitoring procedures will assess volunteer safety, the primary endpoint (diarrhea), stool microbiology (H10407 excretion), and ETEC-specific immunology. All volunteers will receive antibiotic treatment (ciprofloxacin, trimethoprim-sulfamethoxazole or amoxicillin) starting 5 days after ETEC challenge or sooner based on pre-defined clinical criteria. Follow-up visits for 2 weeks post-discharge will monitor safety and immunological parameters.
- Conditions
- Diarrhea
- Being tested
- anti-CFA/I bovine IgG, and anti-CfaE bovine IgG
- Keywords
- traveler's diarrhea, ETEC diarrhea, passive immunization, bovine milk prophylaxis
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CFA/I bovine IgG, and anti-CfaE bovine IgGBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
Prevention of moderate to severe diarrhea.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2007 (estimated)
- Study startMar 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center, Walter Reed Army Institute of Research (WRAIR)
- Investigators
- Robin McKenzie, M.D., Principal investigator, Johns Hopkins School of Public
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00435526
- Sponsor's protocol ID
- CIR 218
- Other IDs
- HMJF Sub Award # 0000090523
- Acronym
- BIgGI
- Status last verified
- Feb 2007
- First submitted
- 13 Feb 2007
- Last updated
- 15 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Efficacy of Orally Delivered Bovine Milk Immunoglobulin (BIgG) Specific for the Minor CFA/I Fimbrial Adhesin CfaE Against Challenge With H10407 Enterotoxigenic E. Coli (ETEC) Strain Expressing CFA/I
- ClinicalTrials.gov ID
- NCT00435526
- Acronym / sponsor ID
- BIgGI / CIR 218
- Conditions
- Diarrhea
- Keywords
- traveler's diarrhea, ETEC diarrhea, passive immunization, bovine milk prophylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Naval Medical Research Center, Walter Reed Army Institute of Research (WRAIR)
- Study start
- Mar 2006
- Study completion
- Oct 2006
- First posted
- 15 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Randomized, double-blinded, placebo-controlled trial involving up to 33 subjects. Subjects will be randomized into one of the following three groups.
Group N Product
- 10 BIgG anti-CFA/I
- 10 BIgG anti-CfaE
- 10 LactoFree® Lipil®
Volunteers will receive the test article three times daily following meals beginning 2 days prior to oral ETEC challenge (strain H10407). Test article will be administered for a total of 7 days. Monitoring procedures will assess volunteer safety, the primary endpoint (diarrhea), stool microbiology (H10407 excretion), and ETEC-specific immunology. All volunteers will receive antibiotic treatment (ciprofloxacin, trimethoprim-sulfamethoxazole or amoxicillin) starting 5 days after ETEC challenge or sooner based on pre-defined clinical criteria. Follow-up visits for 2 weeks post-discharge will monitor safety and immunological parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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 abnormalities in screening lab hematology, serum chemistry, urinalysis or EKG (EKG in volunteers ≥ 40 years), as determined by PI.
- Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to two of three).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-CFA/I bovine IgG, and anti-CfaE bovine IgG | Biological | – |
Primary outcome
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.
1 secondary outcome
Prevention of moderate to severe diarrhea.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin McKenzie, M.D. principal investigator
Johns Hopkins School of Public
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing anti-CFA/I bovine IgG, and anti-CfaE bovine IgG in people with Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2007.