Development of Clostridium Difficile Associated DiarrheaNCT01873872
Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
A study testing Theralac probiotic and Culturelle probiotic in people with Development of Clostridium Difficile Associated Diarrhea, run by St. Vincent's East, Birmingham, Alabama at 1 site in United States.
Trial summary
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea in a population of general inpatients who are receiving antibiotics. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Development of Clostridium Difficile Associated Diarrhea
- What is being tested?
- Theralac probiotic and Culturelle probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2014
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Feeding tube in place
- Pregnancy
- Milk or soy allergy
- Sensitivity to lactose
- Immunocompromised defined as:
- Absolute neutrophil count (ANC) ≤ 500 cells/mm3
Show all 12Show fewer
- HIV
- Cancer patient receiving chemotherapy or radiation therapy
- Immune deficiency
- Post organ transplant
- Participants will be withdrawn from the study if they develop any of the exclusion criteria during the hospitalization.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St. Vincent's East
Birmingham, Alabama, 35235
Leanne Phillips, Pharm.D, 205-838-3109, leanne.phillips@stvhs.com
Mark Middlebrooks, MD, 205-380-0848, markmiddlebrooks@bellsouth.net
About this study
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea
in a population of general inpatients who are receiving antibiotics.
Read the detailed description
General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.
- Being tested
- Theralac probiotic, Culturelle probiotic, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Theralac probioticDietary supplement
Culturelle probioticDietary supplement
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| Theralac probiotic | Active comparator | Not described Receives: Dietary Supplement: Theralac probiotic |
| Culturelle probiotic | Active comparator | Not described Receives: Dietary Supplement: Culturelle probiotic |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014 (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 Development of Clostridium Difficile 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Vincent's East, Birmingham, Alabama
- Sponsor type
- University, hospital or other
- Collaborators
- Master Supplements, Inc
- Responsible party
- Sponsor
- Investigators
- Leanne Phillips, Pharm.D, Principal investigator, St. Vincent's EastWalter Ross, MD, Principal investigator, St. Vincent's EastMark Middlebrooks, MD, Principal investigator, St. Vincent's EastLee Wimberly, MD, Principal investigator, St. Vincent's EastLinda Adams, RPh, Principal investigator, St. Vincent's EastCarrie Castleberry, RN, Principal investigator, St. Vincent's East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873872
- Sponsor's protocol ID
- PROBIOTIC
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 28 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Probiotics and the Development of Clostridium Difficile Associated Diarrhea in Patients Receiving Antibiotics
- ClinicalTrials.gov ID
- NCT01873872
- Acronym / sponsor ID
- PROBIOTIC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Vincent's East, Birmingham, AlabamaUniversity, hospital or other
- Collaborators
- Master Supplements, Inc
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 10 Jun 2013 (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.
We have designed this study to measure the effect of normal flora supplementation, using available probiotics, on the incidence of Clostridium difficile-associated diarrhea
in a population of general inpatients who are receiving antibiotics.
Detailed description
General medical-surgical patients in a community hospital who are receiving antibiotics, and who agree to participate, will be given one of two different probiotics, or placebo. Data will be gathered during their hospitalization, and at one and three months following hospital discharge. We expect to see a lower incidence of Clostridium difficile-associated diarrhea in the probiotic groups when compared to the placebo group. We will also be looking for differences between the effects of the two probiotics, which differ in strain types and number of colony forming units per dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Theralac probiotic | Active comparator | Dietary Supplement: Theralac probiotic |
| Culturelle probiotic | Active comparator | Dietary Supplement: Culturelle probiotic |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (12 listed)
- Feeding tube in place
- Pregnancy
- Milk or soy allergy
- Sensitivity to lactose
- Immunocompromised defined as:
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 |
|---|---|---|
| Theralac probiotic | Dietary supplement | Theralac probiotic |
| Culturelle probiotic | Dietary supplement | Culturelle probiotic |
| placebo | Other | Placebo |
Primary outcome
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics
Time frame: Up to six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
Related trials for Development of Clostridium Difficile Associated Diarrhea
RecruitingObservational study
Natural History of Clostridioides Difficile Infection
Clostridium Difficile Infection, Health Care Associated Infection
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.
Leanne Phillips, Pharm.D principal investigator
St. Vincent's East
Walter Ross, MD principal investigator
St. Vincent's East
Mark Middlebrooks, MD principal investigator
St. Vincent's East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theralac probiotic and Culturelle probiotic in people with Development of Clostridium Difficile Associated Diarrhea, run by St. Vincent's East, Birmingham, Alabama 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 0 inclusion and 12 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 28 Mar 2014. 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.
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?
Contact Mark Middlebrooks, MD (205-380-0848, markmiddlebrooks@bellsouth.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Clostridium difficile associated diarrhea in patients receiving antibiotics (time frame: Up to six months). 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 28 Mar 2014.