Gastrointestinal DiseasesNCT02865564
Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics
A study testing Lactobacillus reuteri DSM 17938 and ampicillin and gentamicin in people with Gastrointestinal Diseases and Colic, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 21 days
- Conditions the study is for
- Gastrointestinal Diseases, Colic
- What is being tested?
- Lactobacillus reuteri DSM 17938 and ampicillin and gentamicin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteSlovenia
- Study dates
- Nov 2016to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Gastrointestinal Diseases, Colic
- Being tested
- Lactobacillus reuteri DSM 17938, Placebo, ampicillin and gentamicin
- Keywords
- 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
- Medical subject headings
- Gastrointestinal Diseases, Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM 17938Dietary supplement
Also called BioGaia
PlaceboDietary supplement
ampicillin and gentamicinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Lactobacillus reuteri DSM 17938; Drug: 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. Receives: Dietary Supplement: Placebo; Drug: ampicillin and gentamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional gastrointestinal dysfunction
Questionnaire [/]
Measured: At 6 months of age
Composition of gut microbiota in infants - 1
[colony-forming units/ml; /]
Measured: At 6 weeks after intervention
Infants crying duration time
Questionnaire [/]
Measured: At 6 months of age
Composition of gut microbiota in infants - 2
[colony-forming units/ml; /]
Measured: At one year of age
Secondary outcomes (8)
Infant weight - 1
[kg]; to calculate body mass index
Measured: At 6 months of age
Bone mineral density in infants - 1
Z-score [/]
Measured: At 6 months of age
Infant height - 1
[m]; to calculate body mass index
Measured: At 6 months of age
Infant weight - 2
[kg]; to calculate body mass index
Measured: At 12 months of age
Bone mineral density in infants - 2
Z-score [/]
Measured: At 12 months of age
Infant height - 2
[m]; to calculate body mass index
Measured: At 12 months of age
Body composition of infants - 1
Measured: At 6 months of age
Body composition of infants - 2
Measured: At 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Jana Lozar Krivec, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865564
- Sponsor's protocol ID
- UPKLjubljana
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2016
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 39486439
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02865564
- Acronym / sponsor ID
- UPKLjubljana
- Conditions
- Gastrointestinal Diseases, Colic
- Keywords
- Probiotics, Anti-Bacterial Agents, Infant, Newborn, Gastrointestinal Microbiome, Colic, Gastrointestinal Diseases, Body Composition, Bone Density
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- Nov 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: Lactobacillus reuteri DSM 17938, Drug: ampicillin and gentamicinThe 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 | Dietary Supplement: Placebo, Drug: ampicillin and gentamicinPlacebo 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. |
Who may qualify
- Ages
- Up to 21 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- term neonates whom antibiotic treatment will be introduced due to clinical suspicion of infection
Key exclusion criteria (7 listed)
- gestational age under 37 weeks
- birth weight less than 2500 grams
- congenital malformations/syndromes
- perinatal hypoxia
- who had received probiotics before the randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus reuteri DSM 17938Also: BioGaia | Dietary supplement | Intervention group |
| Placebo | Dietary supplement | Placebo group |
| ampicillin and gentamicin | Drug | Intervention group, Placebo group |
Primary outcome
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; /]
8 secondary outcomes
Infant weight - 1
Time frame: At 6 months of age
Bone mineral density in infants - 1
Time frame: At 6 months of age
Infant height - 1
Time frame: At 6 months of age
Infant weight - 2
Time frame: At 12 months of age
Bone mineral density in infants - 2
Time frame: At 12 months of age
Infant height - 2
Time frame: At 12 months of age
Body composition of infants - 1
Time frame: At 6 months of age
Body composition of infants - 2
Time frame: At 12 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 39486439Lozar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus reuteri DSM 17938 and ampicillin and gentamicin in people with Gastrointestinal Diseases and Colic, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional gastrointestinal dysfunction (time frame: At 6 months of age). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02865564, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.