Microbiota, Cesarean Section, Probiotics, DysbiosisNCT03657485
Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section
A study testing containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A in people with Microbiota, Cesarean Section, Probiotics, Dysbiosis, run by Jagiellonian University.
Trial summary
Objectives: The gut microbiota plays pivotal role in the maintenance of human health. There are numerous factors, including the mode of delivery, that impact early gut colonization. Recent research focuses on probiotics' use in prophylaxy of gut dysbiosis in the newborns delivered by CS. Read more about this study
- Who is it for?
- Ages 1 hour to 1 day
- Conditions the study is for
- Microbiota, Cesarean Section, Probiotics, Dysbiosis
- What is being tested?
- containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Apr 2017
- 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 1 hour to 1 day
- All sexes
- No healthy volunteers
- Child
Inclusion Criteria:38-40 gestational age, normal, healthy pregnancy, delivery by CS, good clinical condition after birth, Apgar scale- 8-10 points, proper gestational mass> 2500g, informed consent of parents.
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Exclusion Criteria:conditions mentioned above were not fulfilled, lack of informed consent of the parents or their resignation from the study.
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About this study
Official title: Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section: a Randomized, Prospective Clinical Trials
Objectives: The gut microbiota plays pivotal role in the maintenance of human health. There are numerous factors, including the mode of delivery, that impact early gut colonization. Recent research focuses on probiotics' use in prophylaxy of gut dysbiosis in the newborns delivered by CS. We aimed to investigate whether a probiotic supplement in the newborns delivered by CS alter the pattern of gut colonization and has effect on decreasing risk of dysbiosis.
Methods: a prospective, randomized trial with a control group. 150 newborns, born in 38-40 gestational age, delivered by CS were included to the study. They were randomized into 2 groups- interventional supplemented with the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) and control. Stool samples were obtained on 5th and 6th day of life and after one month of life, and analyzed microbiologically in the lab. Bacterial colonies' genre and species were next identified and quantified.
Read the detailed description
The aim of the study was to assess the effect of the probiotic supplementation on microbiota composition of the gut in healthy newborns delivered by CS. We studied colonization of GI tract on the day of discharge from hospital and after a month of life.
It was a prospective, randomized trial with the control group, conducted in the Neonatal Clinic of the Jagiellonian University Hospital in Kraków, lasting from April 2014 to April 2017.
The patients we recruited were randomized into 2 groups- interventional or control group. In the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).
The permission for the clinical trial was granted by the regional medical Bioethical Committee of the Jagiellonian University. (The number of decision- KBET/46/B/2014 from the 27th of March 2014)
- Being tested
- containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53ADietary supplement
Also called FFBaby
we supplemented the probiotic orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).
| Study group | Role | What they receive |
|---|---|---|
| interventional | Experimental | In the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFbaby, IBSS Biomed SA, Poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria). Receives: Dietary Supplement: containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A |
| control | No intervention | No intervention. Feeding with mother milk |
| comperative | No intervention | Comparing stool composition of vaginally born newborns |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota colonization
Stool microbiotic composition
Measured: 1 month of life
Secondary outcomes (1)
respiratory infection, gastrointestinal infection
frequency of respiratory and gastrointestinal infection
Measured: 1 year of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study startApr 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbiota, Cesarean Section, Probiotics, DysbiosisStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients we recruited were randomized into 2 groups- interventional or control group. For comparison we examined the stool samples of 32 healthy newborns delivered vaginally
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Hurkała, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657485
- Sponsor's protocol ID
- KBET/46/B/2014
- Status last verified
- Aug 2018
- First submitted
- 31 Aug 2018
- Last updated
- 5 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participant data available for study statistics and laboratory stuff
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotic Supplementation in the Term Newborns Delivered by Caesarean Section: a Randomized, Prospective Clinical Trials
- ClinicalTrials.gov ID
- NCT03657485
- Acronym / sponsor ID
- KBET/46/B/2014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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.
Objectives: The gut microbiota plays pivotal role in the maintenance of human health. There are numerous factors, including the mode of delivery, that impact early gut colonization. Recent research focuses on probiotics' use in prophylaxy of gut dysbiosis in the newborns delivered by CS. We aimed to investigate whether a probiotic supplement in the newborns delivered by CS alter the pattern of gut colonization and has effect on decreasing risk of dysbiosis.
Methods: a prospective, randomized trial with a control group. 150 newborns, born in 38-40 gestational age, delivered by CS were included to the study. They were randomized into 2 groups- interventional supplemented with the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) and control. Stool samples were obtained on 5th and 6th day of life and after one month of life, and analyzed microbiologically in the lab. Bacterial colonies' genre and species were next identified and quantified.
Detailed description
The aim of the study was to assess the effect of the probiotic supplementation on microbiota composition of the gut in healthy newborns delivered by CS. We studied colonization of GI tract on the day of discharge from hospital and after a month of life.
It was a prospective, randomized trial with the control group, conducted in the Neonatal Clinic of the Jagiellonian University Hospital in Kraków, lasting from April 2014 to April 2017.
The patients we recruited were randomized into 2 groups- interventional or control group. In the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFBaby, IBSS BioMed SA, Poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).
The permission for the clinical trial was granted by the regional medical Bioethical Committee of the Jagiellonian University. (The number of decision- KBET/46/B/2014 from the 27th of March 2014)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The patients we recruited were randomized into 2 groups- interventional or control group. For comparison we examined the stool samples of 32 healthy newborns delivered vaginally
| Arm | Type | Receives |
|---|---|---|
| interventional | Experimental | Dietary Supplement: containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53AIn the interventional group we supplemented the probiotic containing Bifidobacterium breve PB04 i Lactobacillus rhamnosus KL53A (FFbaby, IBSS Biomed SA, Poland) orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria). |
| control | No intervention | –No intervention. Feeding with mother milk |
| comperative | No intervention | –Comparing stool composition of vaginally born newborns |
Who may qualify
- Ages
- 1 hour to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53AAlso: FFBabywe supplemented the probiotic orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria). | Dietary supplement | interventional |
Primary outcome
microbiota colonization
Time frame: 1 month of life
Stool microbiotic composition
1 secondary outcome
respiratory infection, gastrointestinal infection
Time frame: 1 year of life
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 5 Sep 2018.
- Individual participant dataSharing planned: No. participant data available for study statistics and laboratory stuff
Related trials for Microbiota, Cesarean Section, Probiotics, Dysbiosis
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Infant Microbiota Restoration With Maternal Microbes
Infant, Newborn, Gut -Microbiota
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.
Questions about this trial
What is this clinical trial studying?
A study testing containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A in people with Microbiota, Cesarean Section, Probiotics, Dysbiosis, run by Jagiellonian University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
microbiota colonization (time frame: 1 month of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2018.