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Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02865564
Recruitment Status : Active, not recruiting
First Posted : August 12, 2016
Last Update Posted : January 16, 2019
Sponsor:
Collaborator:
University of Ljubljana
Information provided by (Responsible Party):
Jana Lozar Krivec, University Medical Centre Ljubljana

Tracking Information
First Submitted Date  ICMJE August 4, 2016
First Posted Date  ICMJE August 12, 2016
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • Functional gastrointestinal dysfunction [ Time Frame: At 6 months of age ]
    Questionnaire [/]
  • Composition of gut microbiota in infants - 1 [ Time Frame: At 6 weeks after intervention ]
    [colony-forming units/ml; /]
  • Infants crying duration time [ Time Frame: At 6 months of age ]
    Questionnaire [/]
  • Composition of gut microbiota in infants - 2 [ Time Frame: At one year of age ]
    [colony-forming units/ml; /]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02865564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • Infant weight - 1 [ Time Frame: At 6 months of age ]
    [kg]; to calculate body mass index
  • Bone mineral density in infants - 1 [ Time Frame: At 6 months of age ]
    Z-score [/]
  • Infant height - 1 [ Time Frame: At 6 months of age ]
    [m]; to calculate body mass index
  • Infant weight - 2 [ Time Frame: At 12 months of age ]
    [kg]; to calculate body mass index
  • Bone mineral density in infants - 2 [ Time Frame: At 12 months of age ]
    Z-score [/]
  • Infant height - 2 [ Time Frame: At 12 months of age ]
    [m]; to calculate body mass index
  • Body composition of infants - 1 [ Time Frame: At 6 months of age ]
  • Body composition of infants - 2 [ Time Frame: At 12 months of age ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics
Official Title  ICMJE Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics on Emergence of Functional Gastrointestinal Disorders, Body Composition, Mineral Bone Density and Fecal Microbiota in Infancy
Brief Summary The aim of the study is to elucidate the relationship between postnatal antibiotic administration on development of gut microbiota and possible protective influence of simultaneously administration of probiotic during antibiotic therapy on development of gut microbiota, functional gastrointestinal disorders of infancy, weight gain and body composition.
Detailed Description

The study is double-blind, placebo-controlled randomised trial and is composed from two parts. First part of the study aims to examine any difference in gut microbiota after postnatal antibiotic administration between the neonates who received probiotic Lactobacillus reuteri DSM 17938 or placebo and to compare the gut microbiota of patients to microbiota of healthy newborns. Second part of the study aims to determine whether probiotic L. reuteri DSM 17938 supplementation to antibiotic therapy has any beneficial influence on incidence of functional gastrointestinal disorders of infancy and body composition and bone density 6 weeks and one year after inclusion in the study.

Additionally the associations of the clinical parameters with the composition and developmental characteristics of fecal microbiota during antibiotic treatment in children will be evaluated; relevant clinical data such as mode of delivery, child's nutrition, health problems, growth and developmental attributes which could be found associated with fecal microbial community, will be tracked and statistically evaluated for the investigated population.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Gastrointestinal Diseases
  • Colic
Intervention  ICMJE
  • Dietary Supplement: Lactobacillus reuteri DSM 17938
    Other Name: BioGaia
  • Dietary Supplement: Placebo
  • Drug: ampicillin and gentamicin
Study Arms  ICMJE
  • Active Comparator: Intervention group
    The intervention group will receive 5 drops, a minimum of 100 million live Lactobacillus reuteri DSM 17938 a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
    Interventions:
    • Dietary Supplement: Lactobacillus reuteri DSM 17938
    • Drug: ampicillin and gentamicin
  • Placebo Comparator: Placebo group
    Placebo group will receive 5 drops of maltodextrin in the some oil suspension a day during antibiotic treatment (empirical treatment for neonatal sepsis with ampicillin and gentamicin) and 6 consecutive weeks after finishing the antibiotic treatment.
    Interventions:
    • Dietary Supplement: Placebo
    • Drug: ampicillin and gentamicin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 14, 2019)
98
Original Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
100
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection

Exclusion Criteria:

  • gestational age under 37 weeks
  • birth weight less than 2500 grams
  • congenital malformations/syndromes
  • perinatal hypoxia
  • who had received probiotics before the randomization
  • have had cow's milk protein allergy diagnosed during the study
  • patient who will be treated with antibiotic for less than 5 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 21 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02865564
Other Study ID Numbers  ICMJE UPKLjubljana
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jana Lozar Krivec, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE University of Ljubljana
Investigators  ICMJE Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP