Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Ljubljana | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri DSM 17938 | Dietary Supplement |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant weight - 1 | [kg]; to calculate body mass index | At 6 months of age |
| Bone mineral density in infants - 1 | Z-score [/] | At 6 months of age |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39486439 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D003085 | Colic |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
| ID | Term |
|---|---|
| D000667 | Ampicillin |
| D005839 | Gentamicins |
| ID | Term |
|---|---|
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
|
| ampicillin and gentamicin | Drug |
|
| Infant height - 1 | [m]; to calculate body mass index | At 6 months of age |
| Infant weight - 2 | [kg]; to calculate body mass index | At 12 months of age |
| Bone mineral density in infants - 2 | Z-score [/] | At 12 months of age |
| Infant height - 2 | [m]; to calculate body mass index | At 12 months of age |
| Body composition of infants - 1 | At 6 months of age |
| Body composition of infants - 2 | At 12 months of age |
| Amides |
| D009930 | Organic Chemicals |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |