NCT02865564

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3.3 years

First QC Date

August 4, 2016

Last Update Submit

January 29, 2024

Conditions

Gastrointestinal DiseasesColic

Keywords

ProbioticsAnti-Bacterial AgentsInfant, NewbornGastrointestinal MicrobiomeColicGastrointestinal DiseasesBody CompositionBone DensityRandomized Controlled TrialLactobacillus reuteriPediatricsFecesultrasonographyHigh-Throughput Nucleotide SequencingElectric ImpedanceSurveys and Questionnaires

Outcome Measures

Primary Outcomes (4)

  • Functional gastrointestinal dysfunction

    Questionnaire \[/\]

    At 6 months of age

  • Composition of gut microbiota in infants - 1

    \[colony-forming units/ml; /\]

    At 6 weeks after intervention

  • Infants crying duration time

    Questionnaire \[/\]

    At 6 months of age

  • Composition of gut microbiota in infants - 2

    \[colony-forming units/ml; /\]

    At one year of age

Secondary Outcomes (8)

  • Infant weight - 1

    At 6 months of age

  • Bone mineral density in infants - 1

    At 6 months of age

  • Infant height - 1

    At 6 months of age

  • Infant weight - 2

    At 12 months of age

  • Bone mineral density in infants - 2

    At 12 months of age

  • +3 more secondary outcomes

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

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 17938Drug: ampicillin and gentamicin

Placebo group

PLACEBO COMPARATOR

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: PlaceboDrug: ampicillin and gentamicin

Interventions

Lactobacillus reuteri DSM 17938DIETARY_SUPPLEMENT
Also known as: BioGaia
Intervention group
PlaceboDIETARY_SUPPLEMENT
Placebo group
ampicillin and gentamicinDRUG
Intervention groupPlacebo group

Eligibility Criteria

AgeUp to 21 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (1)

  • Lozar Krivec J, Bratina P, Valcl A, Lozar Manfreda K, Petrovcic A, Benedik E, Obermajer T, Bogovic Matijasic B, Setina U, Rupnik M, Mahnic A, Paro-Panjan D. Effects of Limosilactobacillus reuteri DSM 17938 in neonates exposed to antibiotics: a randomised controlled trial. Benef Microbes. 2024 Oct 31;16(2):157-169. doi: 10.1163/18762891-bja00049.

    PMID: 39486439DERIVED

MeSH Terms

Conditions

Gastrointestinal DiseasesColic

Interventions

AmpicillinGentamicins

Condition Hierarchy (Ancestors)

Digestive System DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Penicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 12, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)