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

NCT01295918 | Completed Phase 3 DMC

• 1 other identifier: 128/13.01.2011
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Antibiotic Associated Diarrhea; Clostridium Difficile Infection; Gastroenteritis

Keywords

probiotic; AAD; Lactobacillus reuteri; diarrhea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Incidence of mild diarrhea and severity if diarrhea in children with probiotic treatment

  2 years

• Severity of diarrhoea in patients ingesting L. reuteri versus placebo

  2 years

• Frequency of stool samples positive for C. difficile toxin A and B

  2 years

• Frequencies of other gastrointestinal symptoms

  2 years

Study Arms (2)

Placebo, antibiotic, diarrhea

NO INTERVENTION

L. reuteri, Antibiotic, diarrhoea

PLACEBO COMPARATOR

L. reuteri will be ingested by patients on antibiotic therapy, effect of probiotic on AAD will be assessed.

Dietary Supplement: L reuteri in children on antibiotics

Interventions

L reuteri in children on antibiotics DIETARY_SUPPLEMENT

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.

L. reuteri, Antibiotic, diarrhoea

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St Marina University Hospital, Varna, Bulgaria: lead

Study Sites (2)

St Marina University Hospital

Varna, 9002, Bulgaria

Location

Department of Pediatrics at St Marina University Hospital, Varna

Varna, 9010, Bulgaria

Location

MeSH Terms

Conditions

Clostridium Infections; Gastroenteritis; Diarrhea

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miglena I Georgieva, PhD

  Pediatric gastroenterology ward

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Miglena Georgieva, MD, PhD, St Marina University Hospital, Varna, Bulgaria.

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

BU (2)