- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01295918
Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children (AADreuter)
September 7, 2013 updated by: Miglena Georgieva, St Marina University Hospital, Varna, Bulgaria
Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents
The purpose of this study is to determine if the daily intake of the probiotic Lactobacillus reuteri prevents antibiotic-associated diarrhoea and related Clostridium difficile infections in children and adolescents.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Antibiotic-associated diarrhoea (AAD) occurs in up to 25% of all individuals receiving antibiotics (Bartlett, 2002).
In hospitalized patients, AAD is related to significant increases in mortality, length of stay, and cost of medical care (McFarland, 2006).
Twenty-nine percent of hospitalized patients may develop diarrhoea after antibiotic use; therefore, identifying strategies to minimize antibiotic-associated diarrhoea could be of significant medical and economic advantage (McFarland, 1998).
A promising tool in this area is the probiotic Lactobacillus reuteri
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Varna, Bulgaria, 9002
- St Marina University Hospital
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Varna, Bulgaria, 9010
- Department of Pediatrics at St Marina University Hospital, Varna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 3 - 18 years of age
- Receiving antibiotics for not more than 48 hours prior to enrolment and free from diarrhoea
- The signed informed consent by one/both parents / legal guardian and by the subject if she/he is 12 years or older
- Available throughout the study period
- No use of any other probiotic products during the study period (Bulgarian yoghurt without added probiotics can be used)
- Subject or parents/guardian should have the mental ability to understand and willingness to fulfil 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
- Enteral or parenteral nutrition only
- Requiring care in an intensive care unit
- Status post-bowel resection during hospitalization
- Receiving antibiotics four weeks prior to hospitalization
- Patient with severe life threatening illness or immunocompromised (HIV/AIDS, cancer, genetic disorders including cystic fibrosis, children with opportunistic infections, metabolic diseases)
- Pregnancy
- Lack of possibility to store the study product in a temperature below 25°C during the hot season of the year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Placebo, antibiotic, diarrhea
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Placebo Comparator: L. reuteri, Antibiotic, diarrhoea
L. reuteri will be ingested by patients on antibiotic therapy, effect of probiotic on AAD will be assessed.
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Each patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance.
The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess if the probiotic L. reuteri is effective in preventing AAD in children
Time Frame: 2 years
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Incidence of diarrhea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period, measured as mean number of episodes per patient.
An episode of diarrhea is defined as three or more (≥ 3) soft and unformed or watery bowel movements per day for at least 48 hours.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment
Time Frame: 2 years
|
Incidence of mild diarrhoea during and after treatment with antibiotics in patients ingesting L. reuteri versus placebo during the study period is measured as mean number of episodes per patient.
An episode of mild diarrhoea is defined as any soft and unformed or watery bowel movements not fulfilling the definition of AAD.
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2 years
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Severity of diarrhoea in patients ingesting L. reuteri versus placebo
Time Frame: 2 years
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Severity of diarrhoea in patients ingesting L. reuteri versus placebo is measured as the total number of soft and unformed or watery bowel movements during an episode of diarrhoea and the presence of blood and mucus in faeces.
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2 years
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Frequency of stool samples positive for C. difficile toxin A and B
Time Frame: 2 years
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Frequency of stool samples positive for C. difficile toxin A and B at baseline, when presenting with diarrhoea during the study period, and at the follow-up 21 days post-antibiotic treatment is done to detect possible clearance of C. difficile, in patients ingesting L. reuteri versus placebo.
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2 years
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Frequencies of other gastrointestinal symptoms
Time Frame: 2 years
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Frequencies of other gastrointestinal symptoms during antibiotic use and 7 and 21 days after cessation of antibiotic use, in the L. reuteri group versus placebo is to be assessed by the validated GSRS score (Gastrointestinal Symptom Rating Score, Svedlund et al., 1988).
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Miglena I Georgieva, PhD, Pediatric gastroenterology ward
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
February 14, 2011
First Submitted That Met QC Criteria
February 14, 2011
First Posted (Estimate)
February 15, 2011
Study Record Updates
Last Update Posted (Estimate)
September 10, 2013
Last Update Submitted That Met QC Criteria
September 7, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease Attributes
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Infections
- Communicable Diseases
- Diarrhea
- Gastroenteritis
- Clostridium Infections
- Anti-Infective Agents
- Anti-Bacterial Agents
Other Study ID Numbers
- 128/13.01.2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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