DiarrheaNCT02076438
Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease
A study testing Probiotics in people with Diarrhea, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Diarrhea
- What is being tested?
- Probiotics
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Sep 2016
- 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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.
Who cannot join
- Diarrhea on admission or within the preceding week
- Reported recurrent diarrhea
- Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
- Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
- Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
- Bowel surgery causing liquid stools
- Regular probiotic intake before admission
- Lactose intolerance or intolerance to dairy products
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Peters University Hospital
New Brunswick, New Jersey, 08824
About this study
Official title: Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial
The study will evaluate if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.
Read the detailed description
Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is:
- Diarrhea on admission or within the preceding week
- Reported recurrent diarrhea
- Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
- Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
- Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
- Bowel surgery causing liquid stools
- Regular probiotic intake before admission
- Lactose intolerance or intolerance to dairy products.
- Conditions
- Diarrhea
- Being tested
- Probiotics
- Keywords
- antibiotics, diarrhea, c diff, Hospitalized patients
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticsDietary supplement
Also called Lactobacillus Rhamnosus GG 10 billion cfu bid
Randomized to receive probiotics or placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules Receives: Dietary Supplement: Probiotics |
| Probiotics | Experimental | Lactobacillus Rhamnosus GG 10 billion cfu BID Receives: Dietary Supplement: Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diarrhea
Diarrhea associated with antibiotics
Measured: 4 weeks
Secondary outcomes (1)
Tolerability of probiotics
Patient experience with use of probiotics
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionSep 2016
Why it stopped: Lack of recruitment
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.
- More trials run by Rutgers, The State University of New JerseyThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Peters University Hospital
- Responsible party
- Principal investigator, Amita Avadhani, DNP, DCC, ACNP, ANP, CCRN, Rutgers, The State University of New Jersey
- Investigators
- Amita Avadhani, DNP, Principal investigator, Rutgers University and Saint Peters University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076438
- Sponsor's protocol ID
- Pro2012002450
- Other IDs
- Grant# PC 14-13
- Status last verified
- Nov 2016
- First submitted
- 25 Feb 2014
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics for Prevention of Antibiotic Associated Diarrhea and Clostridium Difficile Associated Disease in Hospitalized Adults-A Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02076438
- Acronym / sponsor ID
- Pro2012002450
- Conditions
- Diarrhea
- Keywords
- antibiotics, diarrhea, c diff, Hospitalized patients
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Saint Peters University Hospital
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Mar 2014 (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 if administration of probiotic Culturelle (Lactobacillus Rhamnosus GG) along with antibiotics can help decrease the occurrence of diarrhea caused by antibiotics as well as Clostridium difficile Diarrhea.
Detailed description
Inpatient adult males and females who are at least 18 years of age or older, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics. The setting is an academic hospital.The patients are screened and potentially recruited upon initiation of antibiotic treatment regardless of indication for antibiotic prescription. The participants are patients being admitted to any inpatient units of the hospital for treatment with antibiotics. Exclusion criteria is:
- Diarrhea on admission or within the preceding week
- Reported recurrent diarrhea
- Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
- Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
- Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
- Bowel surgery causing liquid stools
- Regular probiotic intake before admission
- Lactose intolerance or intolerance to dairy products.
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 |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: ProbioticsPlacebo capsules |
| Probiotics | Experimental | Dietary Supplement: ProbioticsLactobacillus Rhamnosus GG 10 billion cfu BID |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatient adult males and females who are at least 18-89 years of age, undergoing treatment with antibiotics irrespective of indication and the type of antibiotics.
Key exclusion criteria (8 listed)
- Diarrhea on admission or within the preceding week
- Reported recurrent diarrhea
- Bowel pathology that could result in diarrhea (including preexisting Inflammatory Bowel disease{IBD}, all forms for colitis or any other condition resulting in preexisting diarrhea)
- Intake of high risk antibiotics (clindamycin, cephalosporins, aminopenicillins→ well known to cause CDAD) and or more than two courses of other antibiotics in the past four weeks to exclude pre-existing diarrhea associated with antibiotic use
- Immunosuppression (Chronic steroid use, Active chemotherapy, Active radiotherapy, HIV or any other disorder resulting in a compromise in participants immune status)
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 |
|---|---|---|
| ProbioticsAlso: Lactobacillus Rhamnosus GG 10 billion cfu bidRandomized to receive probiotics or placebo | Dietary supplement | Placebo, Probiotics |
Primary outcome
Diarrhea
Time frame: 4 weeks
Diarrhea associated with antibiotics
1 secondary outcome
Tolerability of probiotics
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
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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.
Amita Avadhani, DNP principal investigator
Rutgers University and Saint Peters University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in people with Diarrhea, run by Rutgers, The State University of New Jersey 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 1 inclusion and 8 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 23 Nov 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.
Are results available for this study?
The study was stopped early (reason given: Lack of 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?
Diarrhea (time frame: 4 weeks). 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 23 Nov 2016.