Antibiotic Associated DiarrheaNCT01596153
Probiotics in Hospitalized Patients Study
A study testing Go Live in people with Antibiotic Associated Diarrhea and Clostridium Difficile Associated Diarrhea, run by South Shore Hospital.
Trial summary
The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antibiotic Associated Diarrhea, Clostridium Difficile Associated Diarrhea
- What is being tested?
- Go Live
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years of age or older admitted to SSH and prescribed antibiotics for an expected duration >3 days (may include patients on antibiotics prior to admission).
Who cannot join
- 1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC <1000, AIDS/CD4 count <200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries
About this study
Official title: Randomized Double-blind, Placebo-Controlled Trial Comparing the the Effect of Enhance Probiotic (EP, Go Live Rx,) Versus Placebo (Pl) on the Incidence of Clostridium Difficile Associated Diarrhea (CDAD) or Antibiotic-Associated Diarrhea (AAD)in Hospitalized Patients Initiated on Antibiotics
The purpose of this study is to compare the effect of enhanced probiotic (EP, Live Rx) versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.
- Being tested
- Go Live
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Go LiveDietary supplement
Enhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | BID Receives: Dietary Supplement: Go Live |
| Go Live Rx Probiotic | Active comparator | BID Receives: Dietary Supplement: Go Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
Measured: 60 days after hospitalization
Secondary outcomes (1)
Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
Measured: 60 Days after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
Why it stopped: The study was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic Associated 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Shore Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596153
- Sponsor's protocol ID
- SSH 10-006
- Status last verified
- Nov 2014
- First submitted
- 8 May 2012
- Last updated
- 18 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind, Placebo-Controlled Trial Comparing the the Effect of Enhance Probiotic (EP, Go Live Rx,) Versus Placebo (Pl) on the Incidence of Clostridium Difficile Associated Diarrhea (CDAD) or Antibiotic-Associated Diarrhea (AAD)in Hospitalized Patients Initiated on Antibiotics
- ClinicalTrials.gov ID
- NCT01596153
- Acronym / sponsor ID
- SSH 10-006
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- South Shore HospitalUniversity, hospital or other
- First posted
- 10 May 2012 (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 compare the effect of enhanced probiotic (EP, Live Rx) versus placebo (PL) on the incidence of Clostridium difficile associated diarrhea (CDAD) or antibiotic associated diarrhea (AAD) in hospitalized patients initiated on antibiotics.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Go LiveBID |
| Go Live Rx Probiotic | Active comparator | Dietary Supplement: Go LiveBID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years of age or older admitted to SSH and prescribed antibiotics for an expected duration >3 days (may include patients on antibiotics prior to admission).
Key exclusion criteria (1 listed)
- 1. History of chronic diarrhea illness (Irritable Bowel Disease (IBD), Irritable Bowel Syndrome (IBS), Celiac Disease, Chronic pancreatitis 2. Diarrhea at screening 3. Active Colitis of any etiology 4. History of colectomy 5. Regular consumption of probiotics within 72 hours 6. Unable to provide written consent 7. History of or active pancreatitis 8. Severe Sepsis or Septic Shock (sepsis with end organ failure e.g. renal failure, ARDS, MS changes and or meets criteria by n ational guideline, and or requiring vasopressors) 9. Hypersensitivity to any ingredient in probiotic product 10. Severe Immunosuppression (ANC <1000, AIDS/CD4 count <200 cells, cancer on active chemothereapy, h/o of solid or bone marrow transplant) 12. Acute burn injuries
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 |
|---|---|---|
| Go LiveEnhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic | Dietary supplement | Go Live Rx Probiotic, Placebo |
Primary outcome
Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
Time frame: 60 days after hospitalization
1 secondary outcome
Incidence of Antibiotic associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo
Time frame: 60 Days after hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Go Live in people with Antibiotic Associated Diarrhea and Clostridium Difficile Associated Diarrhea, run by South Shore Hospital.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 18 Nov 2014. 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. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of Clostridium difficle associated diarrhea in patients randomized to Go Live Rx compared with those randomized to placebo (time frame: 60 days after hospitalization). 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 18 Nov 2014.