Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children
NCT ID: NCT01295918
Last Updated: 2013-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2011-02-28
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Placebo, antibiotic, diarrhea
No interventions assigned to this group
L. reuteri, Antibiotic, diarrhoea
L. reuteri will be ingested by patients on antibiotic therapy, effect of probiotic on AAD will be assessed.
L reuteri in children on antibiotics
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.
Interventions
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L reuteri in children on antibiotics
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
3 Years
18 Years
ALL
No
Sponsors
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St Marina University Hospital, Varna, Bulgaria
OTHER
Responsible Party
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Miglena Georgieva
Assoc Prof Miglena Georgieva, MD, PhD, St Marina University Hospital, Varna, Bulgaria.
Principal Investigators
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Miglena I Georgieva, PhD
Role: PRINCIPAL_INVESTIGATOR
Pediatric gastroenterology ward
Locations
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St Marina University Hospital
Varna, , Bulgaria
Department of Pediatrics at St Marina University Hospital, Varna
Varna, , Bulgaria
Countries
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Other Identifiers
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128/13.01.2011
Identifier Type: -
Identifier Source: org_study_id