Probiotic Lactobacillus Reuteri to Prevent Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children

Clostridium Difficile Infection Clinical Trial

— AADreuter  

Official title:

Efficacy of the Probiotic Lactobacillus Reuteri in Prevention of Antibiotic-associated Diarrhea and Clostridium Difficile-related Infections in Hospitalized Children and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01295918
• Other study ID #: 128/13.01.2011
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2011
• Last updated: September 7, 2013
• Start date: February 2011
• Est. completion date: September 2013

Study information

• Verified date: September 2013
• Source: St Marina University Hospital, Varna, Bulgaria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Ethics committee at St Marina University Hospital, Varna
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Antibiotic Associated Diarrhea
• Clostridium Difficile Infection
• Diarrhea
• Gastroenteritis
• Infection

Intervention

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Bulgaria	Department of Pediatrics at St Marina University Hospital, Varna	Varna
Bulgaria	St Marina University Hospital	Varna

Sponsors (1)

Lead Sponsor	Collaborator
St Marina University Hospital, Varna, Bulgaria

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess if the probiotic L. reuteri is effective in preventing AAD in children	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	Yes
Secondary	Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment	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.	2 years	Yes
Secondary	Severity of diarrhoea in patients ingesting L. reuteri versus placebo	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.	2 years	Yes
Secondary	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 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.	2 years	Yes
Secondary	Frequencies of other gastrointestinal symptoms	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).	2 years	Yes