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Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics

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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

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Diseases Colic Dietary Supplement: Lactobacillus reuteri DSM 17938 Dietary Supplement: Placebo Drug: ampicillin and gentamicin Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Dietary Supplement: Lactobacillus reuteri DSM 17938
Other Name: BioGaia

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.
Dietary Supplement: Placebo
Drug: ampicillin and gentamicin



Primary Outcome Measures :
  1. Functional gastrointestinal dysfunction [ Time Frame: At 6 months of age ]
    Questionnaire [/]

  2. Composition of gut microbiota in infants - 1 [ Time Frame: At 6 weeks after intervention ]
    [colony-forming units/ml; /]

  3. Infants crying duration time [ Time Frame: At 6 months of age ]
    Questionnaire [/]

  4. Composition of gut microbiota in infants - 2 [ Time Frame: At one year of age ]
    [colony-forming units/ml; /]


Secondary Outcome Measures :
  1. Infant weight - 1 [ Time Frame: At 6 months of age ]
    [kg]; to calculate body mass index

  2. Bone mineral density in infants - 1 [ Time Frame: At 6 months of age ]
    Z-score [/]

  3. Infant height - 1 [ Time Frame: At 6 months of age ]
    [m]; to calculate body mass index

  4. Infant weight - 2 [ Time Frame: At 12 months of age ]
    [kg]; to calculate body mass index

  5. Bone mineral density in infants - 2 [ Time Frame: At 12 months of age ]
    Z-score [/]

  6. Infant height - 2 [ Time Frame: At 12 months of age ]
    [m]; to calculate body mass index

  7. Body composition of infants - 1 [ Time Frame: At 6 months of age ]
  8. Body composition of infants - 2 [ Time Frame: At 12 months of age ]


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Ages Eligible for Study:   up to 21 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02865564


Locations
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Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana

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Responsible Party: Jana Lozar Krivec, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02865564     History of Changes
Other Study ID Numbers: UPKLjubljana
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: January 16, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jana Lozar Krivec, University Medical Centre Ljubljana:
Probiotics
Anti-Bacterial Agents
Infant, Newborn
Gastrointestinal Microbiome
Colic
Gastrointestinal Diseases
Body Composition
Bone Density
Randomized Controlled Trial
Lactobacillus reuteri
Pediatrics
Feces
ultrasonography
High-Throughput Nucleotide Sequencing
Electric Impedance
Surveys and Questionnaires
Additional relevant MeSH terms:
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Ampicillin
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Gentamicins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action