Travelers' DiarrheaPhase 2BIgGIINCT00524004
Safety and Efficacy of Bovine Milk Immunoglobulin Against CS17 and CsbD
A Phase 2 study testing Anti-CsbD Bovine IgG and Anti-CS17 Bovin IgG in people with Travelers' Diarrhea, run by Johns Hopkins Bloomberg School of Public Health at 2 sites in United States.
Trial summary
This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Travelers' Diarrhea
- What is being tested?
- Anti-CsbD Bovine IgG and Anti-CS17 Bovin IgG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jan 2007to 26 Oct 2007
- Phase
- Phase 2
- 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 exam findings or clinically significant lab abnormalities, as determined by the PI
- Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written exam (pass grade ≥ 70%)
- Willing to participate after informed consent obtained
- Available for all planned follow-up visits
- Negative serum pregnancy test at screening; on the day of admission to the inpatient phase for female subjects 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 unable to bear children must have this documented (e.g., tubal ligation or hysterectomy).
Who cannot join
- Presence of significant medical conditions such as psychiatric conditions, gastrointestinal disease (such as peptic ulcer, active gastritis or gastroesophageal reflux disease, inflammatory bowel disease), alcohol or illicit drug abuse/dependency, or lab 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 or HCV antibodies, or HBsAg
- Significant abnormalities in screening hematology, serum chemistry, urinalysis or EKG (EKG in subjects ≥ 40 years), as determined by the PI
- Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to 2 of 3)
- Fewer than 3 stools per week or more than 3 stools per day on a regular basis.
Show all 21Show fewer
- 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 = 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 (bovine milk IgG).
- Travel to countries where ETEC or cholera infection is endemic (most of the developing world) within 2 years prior to bovine milk IgG 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 ETEC or other bacterial enteric pathogens (including Salmonella, Shigella and Campylobacter)
- Use of any investigational drug or any investigational vaccine within 30 days preceding the first dose of test article/placebo, 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) within 30 days preceding the first dose of test article/placebo, or planned use during the active study period. (Topical and intra-articular steroids will not exclude subjects.)
- 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) Subjects will receive a dose of the test article 3 times daily 15 minutes (range 10-25 minutes) after each meal for 7 days. The dose will consist of 2.4 gm anti-CS17 bovine milk IgG, 2.3 gm anti-CsbD bovine milk IgG or 2.8 gm LactoFree® powder suspended in 150 mL of water containing 2 grams of sodium bicarbonate buffer.
- Breakfast and 1st daily dose of test article as described above
- Following a 90-minute fast, subjects will ingest 120 ml of sodium bicarbonate buffer to neutralize stomach acidity.
- One minute later (up to 2 minutes) subjects will ingest the CS17-ETEC challenge inoculum diluted in 30ml sodium bicarbonate buffer.
- Fifteen minutes (range: 10-25 minutes) after drinking the CS17-ETEC inoculum, subjects will ingest the second (Day 0) dose of bovine milk IgG test article or placebo.
- No IgG test articles will be administered immediately following lunch on the day of challenge.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Center for Immunization Research
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medicial Center, Inpatient Unit
Baltimore, Maryland, 21224
About this study
Official title: Protective Efficacy of Orally Delivered Bovine Immunoglobulin, Specific for CS17 Fimbriae and CS17 Minor Fimbrial Adhesin CsbD Against Challenge With a CS17 Strain of Enterotoxigenic Escherichia Coli (ETEC)
This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge.
The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.
Read the detailed description
The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.
STUDY DESIGN This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge.
Subjects (N=39) will be randomized into three groups receiving anti-CS17 bovine milk IgG, anti-CsbD bovine milk IgG, or a placebo control (a commercially available lactose-free infant formula called LactoFree® Lipil®) on study day -2. Subjects will receive three doses a day of the test article 15 minutes (range 10 - 25 minutes) after each of their three daily meals (breakfast, lunch and dinner) for a period of 7 days (i.e., from study day -2 to study day 4). The study will be divided into two cohorts, An initial cohort of 9 subjects (3 per treatment group), will be admitted to the General Clinical Research Center (GCRC) of the Johns Hopkins Hospital for the initial testing of the bovine milk IgG products. A second cohort of 30 subjects will then be admitted to the Bayview inpatient facility to complete the prophylaxis study. Logistical considerations and/or withdrawals or disqualifications prior to admission or after randomization, but prior to receiving the ETEC challenge, may require a third cohort to be admitted to either of these facilities. Allowing for these contingencies, the minimum number of subjects to be challenged with ETEC is 33 total and the maximum number of subjects will be 42. The GCRC Project Review Committee will review the protocol prior to subject admission at the GCRC. A brief description of the two inpatient facilities to be used in this study is provided in Section 6.1.2. Unit doses of the test article powders (as detailed in Table 5) will be suspended in 150 mL of water containing 2 grams of sodium bicarbonate buffer. Doses of the test articles/placebo will be prepared by study staff under the supervision of the research pharmacist. The study staff involved in dose preparation will not be collecting clinical data on subjects. On the fourth day of the inpatient phase (study day 0), after their morning meal and receipt of test article/placebo, subjects will be given 120mL of sodium bicarbonate buffer to neutralize their stomach acidity. About 1 minute later they will ingest a dose of CS17-ETEC strain LSN03-016011/A (5 X 109 cfu) diluted in 30 ml sodium bicarbonate buffer. Subjects will continue to receive three doses a day of the test articles/placebo until study day 4. Subjects meeting preset criteria will be treated with antibiotics within 24 hours of determination by the investigator and test article/placebo administration will be discontinued with initiation of treatment. Subjects who do not receive early antibiotic treatment will start antibiotic treatment on study day 5. Routine discharge is scheduled for day 7, when most subjects are expected to meet the discharge criteria of: they feel well(clinical symptoms resolved or resolving and have taken at least one dose of antibiotic and have 1 stool culture negative for the challenge strain. Subjects may be discharged earlier than day 7 on a case-by-case basis if they meet discharge criteria. The duration of the active study period is approximately seven months, encompassing up to 6 and 1/2 weeks of screening/enrollment, 4 weeks of the inpatient/outpatient phase when data and samples will be collected, 12 weeks for immunology assays, and 2 months for analysis and report.
- Conditions
- Travelers' Diarrhea
- Being tested
- Anti-CsbD Bovine IgG, Placebo, Anti-CS17 Bovin IgG
- Keywords
- Passive immunization, Bovine Milk Immunoglobulin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-CsbD Bovine IgGBiological
Also called Experimental
Three times a day for seven days
PlaceboOther
Also called Lacto-Free milk supplement
Three times a day for seven days
Anti-CS17 Bovin IgGBiological
Also called Experimental
Three times a day for seven days
| Study group | Role | What they receive |
|---|---|---|
| Anti-CsbD Bovine IgG | Experimental | Anti CsbD Bovine Milk Immunoglobulin Receives: Other: Placebo; Biological: Anti-CS17 Bovin IgG |
| Placebo | Experimental | Lacto-free milk supplement Receives: Biological: Anti-CS17 Bovin IgG |
| Anti-CS17 Bovin IgG | Experimental | Anti-CS17 Bovin Milk Immunoglobulin Receives: Biological: Anti-CsbD Bovine IgG; Biological: Anti-CS17 Bovin IgG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of ETEC diarrhea
Measured: 120 hours after challenge
Secondary outcomes (1)
Prevention of moderate to severe ETEC diarrhea
Measured: 120 hours after challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2007 (estimated)
- Study start30 Jan 2007
- Primary completion26 Oct 2007
- Study completion26 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Travelers' 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Naval Medical Research Center
- Responsible party
- Principal investigator, August Louis Bourgeois, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Robin McKenzie, M.D., Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00524004
- Sponsor's protocol ID
- CIR 233
- Other IDs
- WIRB Approval Number 20062031, W81XWH-04-1-0067
- Acronym
- BIgGII
- Status last verified
- Apr 2017
- First submitted
- 31 Aug 2007
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL. Hyperimmune Bovine Colostral Anti-CS17 Antibodies Protect Against Enterotoxigenic Escherichia coli Diarrhea in a Randomized, Doubled-Blind, Placebo-Controlled Human Infection Model. J Infect Dis. 2019 Jul 2;220(3):505-513. doi: 10.1093/infdis/jiz135.
PubMed 30897198
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protective Efficacy of Orally Delivered Bovine Immunoglobulin, Specific for CS17 Fimbriae and CS17 Minor Fimbrial Adhesin CsbD Against Challenge With a CS17 Strain of Enterotoxigenic Escherichia Coli (ETEC)
- ClinicalTrials.gov ID
- NCT00524004
- Acronym / sponsor ID
- BIgGII / CIR 233
- Conditions
- Travelers' Diarrhea
- Keywords
- Passive immunization, Bovine Milk Immunoglobulin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Naval Medical Research Center
- Study start
- 30 Jan 2007 (actual)
- Primary completion
- 26 Oct 2007 (actual)
- Study completion
- 26 Oct 2007 (actual)
- First posted
- 3 Sep 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.
This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge.
The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.
Detailed description
The primary study objectives are: 1) Assess safety of the anti-CsbD and anti-CS17 bovine milk IgG among healthy adult volunteers when orally administered three times a day over 7 days. 2) Determine efficacy of the anti-CsbD bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC, and 3)Determine efficacy of the anti-CS17 bovine milk IgG preparation against ETEC diarrhea upon challenge with CS17-ETEC. A secondary objective is to determine efficacy of the anti-CsbD and anti-CS17 bovine milk IgG preparations against moderate to severe ETEC diarrhea upon challenge with CS17-ETEC.
STUDY DESIGN This is a Phase II, randomized, double-blind, placebo-controlled study designed to investigate whether hyperimmune bovine milk IgG products specific for CsbD and CS17, protect subjects against diarrhea upon challenge with a CS-17-ETEC strain LSN03-016011/A. The study will also evaluate safety and tolerability of these bovine milk IgG products and describe the immune responses following challenge.
Subjects (N=39) will be randomized into three groups receiving anti-CS17 bovine milk IgG, anti-CsbD bovine milk IgG, or a placebo control (a commercially available lactose-free infant formula called LactoFree® Lipil®) on study day -2. Subjects will receive three doses a day of the test article 15 minutes (range 10 - 25 minutes) after each of their three daily meals (breakfast, lunch and dinner) for a period of 7 days (i.e., from study day -2 to study day 4). The study will be divided into two cohorts, An initial cohort of 9 subjects (3 per treatment group), will be admitted to the General Clinical Research Center (GCRC) of the Johns Hopkins Hospital for the initial testing of the bovine milk IgG products. A second cohort of 30 subjects will then be admitted to the Bayview inpatient facility to complete the prophylaxis study. Logistical considerations and/or withdrawals or disqualifications prior to admission or after randomization, but prior to receiving the ETEC challenge, may require a third cohort to be admitted to either of these facilities. Allowing for these contingencies, the minimum number of subjects to be challenged with ETEC is 33 total and the maximum number of subjects will be 42. The GCRC Project Review Committee will review the protocol prior to subject admission at the GCRC. A brief description of the two inpatient facilities to be used in this study is provided in Section 6.1.2. Unit doses of the test article powders (as detailed in Table 5) will be suspended in 150 mL of water containing 2 grams of sodium bicarbonate buffer. Doses of the test articles/placebo will be prepared by study staff under the supervision of the research pharmacist. The study staff involved in dose preparation will not be collecting clinical data on subjects. On the fourth day of the inpatient phase (study day 0), after their morning meal and receipt of test article/placebo, subjects will be given 120mL of sodium bicarbonate buffer to neutralize their stomach acidity. About 1 minute later they will ingest a dose of CS17-ETEC strain LSN03-016011/A (5 X 109 cfu) diluted in 30 ml sodium bicarbonate buffer. Subjects will continue to receive three doses a day of the test articles/placebo until study day 4. Subjects meeting preset criteria will be treated with antibiotics within 24 hours of determination by the investigator and test article/placebo administration will be discontinued with initiation of treatment. Subjects who do not receive early antibiotic treatment will start antibiotic treatment on study day 5. Routine discharge is scheduled for day 7, when most subjects are expected to meet the discharge criteria of: they feel well(clinical symptoms resolved or resolving and have taken at least one dose of antibiotic and have 1 stool culture negative for the challenge strain. Subjects may be discharged earlier than day 7 on a case-by-case basis if they meet discharge criteria. The duration of the active study period is approximately seven months, encompassing up to 6 and 1/2 weeks of screening/enrollment, 4 weeks of the inpatient/outpatient phase when data and samples will be collected, 12 weeks for immunology assays, and 2 months for analysis and report.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anti-CsbD Bovine IgG | Experimental | Other: Placebo, Biological: Anti-CS17 Bovin IgGAnti CsbD Bovine Milk Immunoglobulin |
| Placebo | Experimental | Biological: Anti-CS17 Bovin IgGLacto-free milk supplement |
| Anti-CS17 Bovin IgG | Experimental | Biological: Anti-CsbD Bovine IgG, Biological: Anti-CS17 Bovin IgGAnti-CS17 Bovin Milk Immunoglobulin |
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 exam findings or clinically significant lab abnormalities, as determined by the PI
- Demonstrate comprehension of the protocol procedures and knowledge of ETEC illness by passing a written exam (pass grade ≥ 70%)
- Willing to participate after informed consent obtained
- Available for all planned follow-up visits
Key exclusion criteria (21 listed)
- Presence of significant medical conditions such as psychiatric conditions, gastrointestinal disease (such as peptic ulcer, active gastritis or gastroesophageal reflux disease, inflammatory bowel disease), alcohol or illicit drug abuse/dependency, or lab 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 or HCV antibodies, or HBsAg
- Significant abnormalities in screening hematology, serum chemistry, urinalysis or EKG (EKG in subjects ≥ 40 years), as determined by the PI
- Allergy to fluoroquinolones, trimethoprim-sulfamethoxazole, or ampicillin/penicillin (excluded if allergic to 2 of 3)
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-CsbD Bovine IgGAlso: ExperimentalThree times a day for seven days | Biological | Anti-CS17 Bovin IgG |
| PlaceboAlso: Lacto-Free milk supplementThree times a day for seven days | Other | Anti-CsbD Bovine IgG |
| Anti-CS17 Bovin IgGAlso: ExperimentalThree times a day for seven days | Biological | Anti-CS17 Bovin IgG, Anti-CsbD Bovine IgG, Placebo |
Primary outcome
Prevention of ETEC diarrhea
Time frame: 120 hours after challenge
1 secondary outcome
Prevention of moderate to severe ETEC diarrhea
Time frame: 120 hours after challenge
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 5 Apr 2017.
- Derived from this study: PubMed 30897198Savarino SJ, McKenzie R, Tribble DR, Porter CK, O'Dowd A, Sincock SA, Poole ST, DeNearing B, Woods CM, Kim H, Grahek SL, Brinkley C, Crabb JH, Bourgeois AL. Hyperimmune Bovine Colostral Anti-CS17 Antibodies Protect Against Enterotoxigenic Escherichia coli Diarrhea in a Randomized, Doubled-Blind, Placebo-Controlled Human Infection Model. J Infect Dis. 2019 Jul 2;220(3):505-513. doi: 10.1093/infdis/jiz135.
- Individual participant dataSharing planned: No
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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 Bloomberg School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anti-CsbD Bovine IgG and Anti-CS17 Bovin IgG in people with Travelers' 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 21 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 5 Apr 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Prevention of ETEC diarrhea (time frame: 120 hours after challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00524004, which also lists 1 linked publication.
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 5 Apr 2017.