Caesarean Section;StillbirthPhase 4NCT03154866
Lactobacillus Kefiri LKF01 (DSM32079) in Newborns Born by Caesarian Section
A Phase 4 study testing Lactobacillus kefiri LKF01 DSM32079 in people with Caesarean Section;Stillbirth and Microbial Colonization, run by Policlinico Hospital at 1 site in Italy.
Trial summary
The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life. Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. Read more about this study
- Who is it for?
- Ages 1 hour to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Caesarean Section;Stillbirth, Microbial Colonization
- What is being tested?
- Lactobacillus kefiri LKF01 DSM32079
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2017to 30 Jun 2018
- Phase
- Phase 4
- 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 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Term newborn
- Adeguate for gestational age
- Born by elective cesarean section
- Otherwise healthy newborn
Who cannot join
- major acute or chronic disease
- use of probiotics/antibiotics
- gastrointestinal malformation, cystic fibrosis, other genetic diseases
- concurrent participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Italy1 site
Dept Of Obstetrics and Neonatology - Section of Neonatology University of Bari Policlinico Hospital
Bari, 70124
About this study
Official title: Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section
The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.
Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.
- Being tested
- Lactobacillus kefiri LKF01 DSM32079, Placebo
- Keywords
- Lactobacillus kefiri LKF01 DSM32079, Microbial Colonization
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus kefiri LKF01 DSM32079Dietary supplement
Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
PlaceboDietary supplement
Placebo in drop formulation. 5 drop/daily for 21 days
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus kefiri LKF01 DSM32079 | Experimental | Not described Receives: Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079 |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology.
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample.
Measured: 21 days after supplementation start
Number of participants with treatment-related adverse event
A structured diary on possible treatment-related adverse event will be given to mothers.
Measured: During 21 days after supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 Dec 2017 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Section;StillbirthStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Policlinico Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Maria Elisabetta Baldassarre, Policlinico Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03154866
- Sponsor's protocol ID
- KEFINEO1
- Status last verified
- May 2017
- First submitted
- 10 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ability of Lactobacillus Kefiri LKF01 (DSM32079) to Colonize the Intestinal Environment and Modify the Gut Microbiota Composition of Newborns Born by Caesarian Section
- ClinicalTrials.gov ID
- NCT03154866
- Acronym / sponsor ID
- KEFINEO1
- Keywords
- Lactobacillus kefiri LKF01 DSM32079, Microbial Colonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Policlinico HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 Dec 2017 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 16 May 2017 (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.
The mode of delivery affects the diversity and colonization pattern of the gut microbiota during the first year of infants' life.
Probiotics have been observed to positively influence the host's health, but to date few data about the ability of probiotics to modify the gut microbiota composition exist. 40 newborns born by elective caesarian sectional be randomized to a Lactobacillus kefiri LKF01 DSM32079 (LKEF) supplementation or placebo for 21 days. Changes in the gut microbiota composition were detected by using a Next Generation Sequencing technology.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus kefiri LKF01 DSM32079 | Experimental | Dietary Supplement: Lactobacillus kefiri LKF01 DSM32079 |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 1 hour to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Term newborn
- Adeguate for gestational age
- Born by elective cesarean section
- Otherwise healthy newborn
Key exclusion criteria (4 listed)
- major acute or chronic disease
- use of probiotics/antibiotics
- gastrointestinal malformation, cystic fibrosis, other genetic diseases
- concurrent participation in other clinical trials
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 kefiri LKF01 DSM32079Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days | Dietary supplement | Lactobacillus kefiri LKF01 DSM32079 |
| PlaceboPlacebo in drop formulation. 5 drop/daily for 21 days | Dietary supplement | Placebo |
Primary outcome
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample
Time frame: 21 days after supplementation start
To evaluate the ability of Lactobacillus kefiri LKF01 DSM32079 (LKEF) to colonize the intestinal environment of newborns born by caesarian section and modify the gut microbiota composition by using a Next Generation Sequencing technology. Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample.
Number of participants with treatment-related adverse event
Time frame: During 21 days after supplementation
A structured diary on possible treatment-related adverse event will be given to mothers.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: No
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 Phase 4 study testing Lactobacillus kefiri LKF01 DSM32079 in people with Caesarean Section;Stillbirth and Microbial Colonization, run by Policlinico Hospital at 1 site in Italy.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 May 2017. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Presence of Lactobacillus kefiri LKF01 DSM32079 (LKEF) in fecal sample (time frame: 21 days after supplementation start). The study lists 2 primary outcomes in all. 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 18 May 2017.