Clostridium DifficilePhase 1ProbioticsNCT02589964
Probiotics in the Reduction of Antibiotic Associated Diarrhea
A Phase 1 study testing Florajen-3 in people with Clostridium Difficile, run by TriHealth Inc. at 1 site in United States.
Trial summary
The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Clostridium Difficile
- What is being tested?
- Florajen-3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 2015
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Good Samaritan Hospital
- Placed on pneumonia order set
- Age 18+
Who cannot join
- Patient with inadequate coherency to understand consent
- Active Diarrhea at admission
- Non-controlled intestinal disease
- Documented positive C. difficile infection within the 3 months before enrollment
- Antibiotic use at hospital admission
- Immunosuppressive therapy
Show all 17Show fewer
- Pregnancy
- Allergic to ingredients in Florajen-3
- Allergic to ingredients in placebo
- Immunocompromised state including:
- HIV with a low CD4 count
- Active malignancy receiving chemotherapy
- Medications including long-term steroids (>2 weeks), and disease modifying biologic agents
- Acquired immune deficiency
- Unable to take oral medication
- Less than 4 doses of probiotic or placebo
- Taking probiotic in the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital
The study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.
Read the detailed description
The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.
- Conditions
- Clostridium Difficile
- Being tested
- Florajen-3, Placebo
- Keywords
- probiotics, antibiotic associated diarrhea, clostridium difficile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florajen-3Dietary supplement
Also called probiotic
The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
PlaceboOther
The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are:
Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion Receives: Dietary Supplement: Florajen-3 |
| Placebo | Placebo comparator | Placebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are:
Rice maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic Associated Diarrhea
Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment
Measured: 21 days after starting study treatment
Secondary outcomes (4)
Length of stay
Measured: during hospitalization up to 4 weeks
Mortality
Measured: During hospitalization up to 4 weeks
Healthcare costs
Healthcare costs include direct costs during hospital stay (room, meds, procedures). This is obtained through the TriHealth Decision Support department.
Measured: During hospitalization up to 4 weeks
Clostridium difficile
Data is obtained though a follow-up call to the patient.
Measured: 21 days after initiating study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Low Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clostridium DifficileStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenni Steinbrunner, TriHealth Inc.
- Investigators
- Amita Buddhdev, MD, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589964
- Sponsor's protocol ID
- 13085
- Acronym
- Probiotics
- Status last verified
- Oct 2016
- First submitted
- 13 Apr 2015
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The study was closed due to poor recruitment, so there is no data to share.
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics in the Reduction of Antibiotic Associated Diarrhea and Clostridium Difficile in Pneumonia Patients Within a Community Teaching Hospital
- ClinicalTrials.gov ID
- NCT02589964
- Acronym / sponsor ID
- Probiotics / 13085
- Conditions
- Clostridium Difficile
- Keywords
- probiotics, antibiotic associated diarrhea, clostridium difficile
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low Recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Oct 2015 (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 study will evaluate the effectiveness of probiotic therapy in reducing the incidence of antibiotic associated diarrhea (AAD) and Clostridium difficile associated diarrhea (CDAD) in pneumonia patients.
Detailed description
The study will include patients admitted to Good Samariatan Hospital and placed on the pneumonia order set. After obtaining consent, subjects will be randomized to the proboiotic or placebo group. Subjects will be followed for 21 days after starting the study treatment to determine critical outcomes such as incidence of antibiotic-associated diarrhea and C-Diff. Other outcomes include length of stay, healthcare costs, and death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Florajen-3Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The treatment is Florajen-3. The ingredients in Florajen-3 are: Lactobacillus acidophilus-over 7.5 billion Bifidobacterium lactis-over 6.0 billion Bifidobacterium longum-over 1.5 billion |
| Placebo | Placebo comparator | Other: PlaceboPlacebo will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. The ingredients in the placebo are: Rice maltodextrin |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to Good Samaritan Hospital
- Placed on pneumonia order set
- Age 18+
Key exclusion criteria (17 listed)
- Patient with inadequate coherency to understand consent
- Active Diarrhea at admission
- Non-controlled intestinal disease
- Documented positive C. difficile infection within the 3 months before enrollment
- Antibiotic use at hospital admission
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 |
|---|---|---|
| Florajen-3Also: probioticThe probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. | Dietary supplement | Probiotic |
| PlaceboThe placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days. | Other | Placebo |
Primary outcome
Antibiotic Associated Diarrhea
Time frame: 21 days after starting study treatment
Subjects will be asked to keep a diary for 20 days after starting study treatment and will be contacted by a nurse approximately 21 days after starting study treatment
4 secondary outcomes
Length of stay
Time frame: during hospitalization up to 4 weeks
Mortality
Time frame: During hospitalization up to 4 weeks
Healthcare costs
Time frame: During hospitalization up to 4 weeks
Clostridium difficile
Time frame: 21 days after initiating study treatment
Results and safety
The study was stopped early (reason given: Low Recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
- Individual participant dataSharing planned: No. The study was closed due to poor recruitment, so there is no data to share.
Related trials for Clostridium Difficile
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Autologous Fecal Microbiota Transplantation (Auto-FMT) for Prophylaxis of Clostridium Difficile Infection in Recipients of Allogeneic Hematopoietic Stem Cell Transplantation
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Clostridioides Difficile Infection Recurrence
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VE303 for Prevention of Recurrent Clostridioides Difficile Infection
Clostridium Difficile, Clostridium Difficile Infections
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.
Amita Buddhdev, MD principal investigator
TriHealth Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Florajen-3 in people with Clostridium Difficile, run by TriHealth Inc. at 1 site 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 3 inclusion and 17 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: stopped early, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Low Recruitment). 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?
Antibiotic Associated Diarrhea (time frame: 21 days after starting study treatment). 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 31 Oct 2016.