DiarrheaPhase 3NCT01382199
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
A Phase 3 study testing Lactoferrin in people with Diarrhea, run by Ventria Bioscience.
Trial summary
The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Diarrhea
- What is being tested?
- Lactoferrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Mar 2014
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must meet all of the inclusion criteria listed below at the time of enrollment.
- Male and female patients 50 years of age and older.
- Resident of a participating long term care facility.
- Able to consume 30 mL of liquid solution two time per day by mouth or enteral feeding tube.
- Patient has had no antibiotics in the 4 weeks preceding enrollment in the study.
- Patient has been started on a broad spectrum antibiotic(s) for an infection other than gastroenteritis.
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- Patient has a life expectancy greater than 6 months.
- Patient or health care agent is able and willing to sign a written informed consent.
- Patient or caregiver is able and willing to complete diary of daily bowel movement information (number, formed or unformed, time) during any portion of the 8 week study.
Who cannot join
- Patient has an ileostomy.
- Patient has a prior history of major gastrointestinal surgery such as partial small bowel or colon resection or gastric bypass.
- Patient has a history of inflammatory bowel disease.
- Patient has a history of chronic diarrhea associated with irritable bowel syndrome or other etiologies.
- Patient has a history of severe constipation requiring use of enemas or disimpaction within 30 days prior to enrollment.
- Patient has signs or symptoms of C. difficile infection including diarrhea.
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- Patient has signs or symptoms of acute or chronic diarrhea.
- Patient has known sensitivity or allergy to rice or rice products.
- Patient has significant medical problems which in the judgment of the principal investigator or medical monitor may interfere with participation in the study.
- Patient is not receiving an antibiotic regimen consisting of a broad spectrum antibiotic.
- Patient has participated in an investigational study using an investigational product within 30 days of randomization.
About this study
Official title: A Phase III Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
The purpose of the study is to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients.
- Conditions
- Diarrhea
- Being tested
- Lactoferrin
- Keywords
- Antibiotic Associated Diarrhea in Adult Patients
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoferrinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ven100 | Experimental | Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients Receives: Drug: Lactoferrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of days of antibiotic associated diarrhea during the treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2013 (estimated)
- Study completionMar 2014 (estimated)
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ventria Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Investigators
- Ning Huang, Ph.D., Study director, Ventria Bioscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382199
- Sponsor's protocol ID
- VB-Ven100-2011-01
- Other IDs
- R44AG037211
- Status last verified
- Jun 2011
- First submitted
- 21 Jun 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized, Double Blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
- ClinicalTrials.gov ID
- NCT01382199
- Acronym / sponsor ID
- VB-Ven100-2011-01
- Conditions
- Diarrhea
- Keywords
- Antibiotic Associated Diarrhea in Adult Patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Ventria BioscienceIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2011
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 27 Jun 2011 (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 the study is to Evaluate the Efficacy and Safety of Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ven100 | Experimental | Drug: LactoferrinRecombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- All patients must meet all of the inclusion criteria listed below at the time of enrollment.
Key exclusion criteria (11 listed)
- Patient has an ileostomy.
- Patient has a prior history of major gastrointestinal surgery such as partial small bowel or colon resection or gastric bypass.
- Patient has a history of inflammatory bowel disease.
- Patient has a history of chronic diarrhea associated with irritable bowel syndrome or other etiologies.
- Patient has a history of severe constipation requiring use of enemas or disimpaction within 30 days prior to enrollment.
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 |
|---|---|---|
| Lactoferrin | Drug | Ven100 |
Primary outcome
Reduction in the number of days of antibiotic associated diarrhea during the treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Ning Huang, Ph.D. study director
Ventria Bioscience
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lactoferrin in people with Diarrhea, run by Ventria Bioscience.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Reduction in the number of days of antibiotic associated diarrhea during the treatment period. 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 27 Jun 2011.