Antibiotic-associated DiarrheaNCT02127814
Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile
A study testing Lactobacillus reuteri in people with Antibiotic-associated Diarrhea and Clostridium Difficile, run by Case Western Reserve University at 1 site in United States.
Trial summary
The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic-associated Diarrhea, Clostridium Difficile
- What is being tested?
- Lactobacillus reuteri
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to 31 Dec 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea
- able to understand and sign informed consent and HIPPA
- available throughout the study period
- subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol
Who cannot join
- three or more soft and unformed or watery stools per day at admission
- receiving chemotherapy or radiation therapy
- diagnosis of inflammatory bowel disease
- NPO without PO meds
- neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL)
- HIV positive with a CD4+ T-lymphocyte count <400 per mcL blood
Show all 11Show fewer
- requiring care in an intensive care unit
- status-post bowel resection during hospitalization
- patient's receiving antibiotics four weeks prior to hospitalization
- patient with severe life threatening illness or immunocompromised
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Efficacy and Safety of the Probiotic Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile Related Infections in Hospitalized Adult Patients
The purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.
Read the detailed description
The data being measured for this study include:
Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later.
Secondary variables:
- severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return.
- frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo.
- frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.
- Being tested
- Lactobacillus reuteri
- Keywords
- induced diarrhea, Clostridium difficile toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteriDietary supplement
Also called BioGaia, Probiotic Chewable Tablets
One chewable tablet of 1E8 CFU L. reuteri, once per day
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Experimental | Not described Receives: Dietary Supplement: Lactobacillus reuteri |
| Identical Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Lactobacillus reuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
diarrhea
Instances of diarrhea
Measured: 28+ days
Secondary outcomes (3)
Severity of diarrhea
measured as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return.
Measured: 28+ days
Frequency of stool samples positive for C. difficile toxin A and B
Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post antibiotic-treatment to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo.
Measured: baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days
Frequencies of other gastrointestinal symptoms
Frequencies of other gastrointestinal symptoms at 1, 2 and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score).
Measured: 1, 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2014 (estimated)
- Study startMay 2010
- Primary completionAug 2014
- Study completion31 Dec 2017
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Alison Steiber, Case Western Reserve University
- Investigators
- Alison L Steiber, PhD, RD, LD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127814
- Sponsor's protocol ID
- RES504803
- Status last verified
- Jan 2019
- First submitted
- 23 Jun 2010
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Probiotic Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile Related Infections in Hospitalized Adult Patients
- ClinicalTrials.gov ID
- NCT02127814
- Acronym / sponsor ID
- RES504803
- Keywords
- induced diarrhea, Clostridium difficile toxicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- May 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 May 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 purpose of this study is to find whether Lactobacillus reuteri prevents antibiotic-associated diarrhea and related Clostridium difficile infections. Subjects will be admitted from the University Hospitals Case Medical Center. They will be randomly assigned to an intervention group receiving L. reuteri or a placebo. Supplementation will occur during antibiotic treatment and for an additional 7 days after cessation of treatment. Data collection will occur at baseline, end of antibiotic use, 7 days after antibiotic cessation, and 21 days after antibiotic cessation. Primary data includes diarrhea instances. Secondary data includes severity of diarrhea, presence of C. difficile toxins, and presence of other GI symptoms.
Detailed description
The data being measured for this study include:
Primary outcome = incidence of diarrhea during and after treatment with antibiotics. An episode of diarrhea is defined as the discrete period between the time when stool output meets or exceeds three soft and unformed or watery bowel movements to the time when formed stools return, which must be at least 48 hours later.
Secondary variables:
- severity of diarrhea measured as the discrete period between the time when stool output meets or exceeds 3 soft and unformed or watery bowel movements to the time when formed stools return.
- frequency of stool samples positive for C. Difficile toxin A or B at baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days post-antibiotic-treatment to detect possible clearance of C. Difficile, in patients ingesting L. reuteri versus placebo.
- frequencies of other gastrointestinal symptoms at 1, 2, and 4 weeks, in the L. reuteri group versus placebo and assessed by the validated Gastrointestinal Symptom Rating Score.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri | Experimental | Dietary Supplement: Lactobacillus reuteri |
| Identical Placebo | Placebo comparator | Dietary Supplement: Lactobacillus reuteri |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving antibiotics for not more than 48 hours prior to enrollment and free from diarrhea
- able to understand and sign informed consent and HIPPA
- available throughout the study period
- subjects should have the mental ability to understand and willingness to fulfill all the details of the protocol
Key exclusion criteria (11 listed)
- three or more soft and unformed or watery stools per day at admission
- receiving chemotherapy or radiation therapy
- diagnosis of inflammatory bowel disease
- NPO without PO meds
- neutropenia (an absolute neutrophil count (ANC) of less than 1500/microL)
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 |
|---|---|---|
| Lactobacillus reuteriAlso: BioGaia, Probiotic Chewable TabletsOne chewable tablet of 1E8 CFU L. reuteri, once per day | Dietary supplement | Identical Placebo, L. reuteri |
Primary outcome
diarrhea
Time frame: 28+ days
Instances of diarrhea
3 secondary outcomes
Severity of diarrhea
Time frame: 28+ days
Frequency of stool samples positive for C. difficile toxin A and B
Time frame: baseline, when presenting with diarrhea during the study period, and at the follow-up 21 days
Frequencies of other gastrointestinal symptoms
Time frame: 1, 2 and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2019.
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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.
Alison L Steiber, PhD, RD, LD principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri in people with Antibiotic-associated Diarrhea and Clostridium Difficile, run by Case Western Reserve University 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 4 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: finished, as of the sponsor's last update on 9 Jan 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 28+ days). 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 9 Jan 2019.