Lactobacillus Reuteri in the Prevention of Antibiotic Associated-diarrhea and Clostridium Difficile
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | May 2010 |
| End Date: | December 31, 2017 |
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.
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.
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:
1. 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.
2. 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.
3. 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.
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:
1. 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.
2. 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.
3. 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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
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