DysbiosisNCT03675048
Lactobacillus Reuteri DSM 17938 in Gut Microbiota Development in Infant Born by Caesarean Section
A study testing BioGaia Protectis drops in people with Dysbiosis and Prophylaxis, run by BioGaia AB at 1 site in Russia.
Trial summary
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section. It is anticipated that daily using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis of gut microbiota induced by Caesarean… Read more about this study
- Who is it for?
- Ages 0 to 48 hours
- Conditions the study is for
- Dysbiosis, Prophylaxis
- What is being tested?
- BioGaia Protectis drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteRussia
- Study dates
- 1 Oct 2018to 15 Dec 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 0 to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestational age more than 37 weeks and less than 41 weeks
- age of enrolment is not more than 48 hours
- birth weight is corresponded to gestational age
- Apgar score ≥8 at 5 minutes
- Absence of congenital anomaly and/or clinical or physical abnormalities identified during clinical examination
- Primarily breastfeeding during the first days of life (more than 50%)
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- Parent(s) are willing to comply with the exclusive breastfeeding regime during study period
- Parent(s) are willing to follow dietary recommendations during study period
- Parent(s) are willing to fill in the Diary every day
- Availability of the parent(s) and the infant during study period
- Written informed consent of the parent(s)
Who cannot join
- Chronic diseases or serious health problems of mother or child
- Gastrointestinal tract diseases of mother or child
- Delay in development
- Congenital abnormalities
- Intake of antibiotics by mother orally and / or vaginally during the last trimester of pregnancy
- Intake of probiotics by mother during the last trimester of pregnancy
- Using of general anesthesia during Caesarean section
- Emergency Caesarean section
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Autonomous Healthcare Institution of the Moscow Region "Central clinical hospital of Khimki"
Khimki, Moscow Oblast, 141407
About this study
Official title: Single-center, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial on Estimating the Effect of Probiotic Strain Lactobacillus Reuteri DSM 17938 on Gut Microbiota Modulation in Infants Born by Caesarean Section
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section. It is anticipated that daily using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis of gut microbiota induced by Caesarean section.
Read the detailed description
This is a single-center prospective randomized double-blind placebo-controlled clinical study. The planned duration of the study for each included infant will be 16 weeks, 4 weeks of study drug intake and 12 weeks of follow-up. 140 healthy infants born by Caesarean section will be included in the general group of the study, and 60 healthy infants born by natural vaginal delivery will be included in the control group. For infants included in the control group, all the same protocol requirements and procedures will be applied as for infants in the general group, except for randomization and the study product / placebo intake. Infants included in the general study group will be randomly assigned into the study product / placebo subgroups in 1: 1 ratio. During the study the gut microbiota will be analyzed. Feces samples should be collected no later than 72 hours after birth, and also on 14th day of life ± 3 days, 30th day of life ± 3 days and 112th day of life ± 3 days. Short-chain fatty acids (SCFA) will be analyzed in feces samples.
- Conditions
- Dysbiosis, Prophylaxis
- Being tested
- BioGaia Protectis drops, Placebo
- Keywords
- Gut Microbiota, Cesarean Section, Dysbiosis
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioGaia Protectis dropsDietary supplement
Also called BioGaia® Probiotic. Drops for baby
food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).
PlaceboDietary supplement
Contains same excipients as study drug, without the active ingredient L. Reuteri.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will receive 5 drops (10^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks. Receives: Dietary Supplement: BioGaia Protectis drops |
| Placebo group | Placebo comparator | The placebo group will receive 5 drops twice daily during feeding for 4 weeks. Placebo composition will be identical to that of the study drug but will not contain L. reuteri. Receives: Dietary Supplement: Placebo |
| Control group | No intervention | The infants from the control group will comply with the same requirements and will undergo the same procedures as participants from the main group except for randomization and treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composition of gut microbiota in infants born by Caesarean section
Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 14+/-3 day after delivery.
Measured: 14 days
Secondary outcomes (8)
Composition of gut microbiota in infants born by vaginal delivery
Composition of gut microbiota in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 14+/-3 day after delivery.
Measured: 14 days
Composition of gut microbiota in infants born by vaginal delivery
Composition of gut microbiota in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 30+/-3 day after delivery.
Measured: 30 days
Composition of gut microbiota in infants born by Caesarean section
Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 30+/-3 day after delivery.
Measured: 30 days
Composition of gut microbiota in infants born by Caesarean section
Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 112+/-3 day (16 weeks) after delivery.
Measured: 112 days (16 weeks)
Composition of gut microbiota in infants born by vaginal delivery
Composition of gut microbiota in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 112+/-3 day (16 weeks) after delivery.
Measured: 112 days (16 weeks)
Composition of short-chain fatty acids (SCFA) in infants born by vaginal delivery
Composition of short-chain fatty acids in infants born by vaginal delivery in comparison with infants born by Caesarean section and received L. reuteri DSM 17938 at 14+/-3 day after delivery.
Measured: 14 days
Composition of short-chain fatty acids (SCFAs) in infants born by Caesarean section
Composition of short-chain fatty acids in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 14+/-3 day after delivery.
Measured: 14 days
Adverse events assessment
Incidence of adverse events observed during usage of L. reuteri DSM 17938 in drop form.
Measured: 112 days (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start1 Oct 2018
- Primary completion5 Oct 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675048
- Sponsor's protocol ID
- CSUB0142
- Status last verified
- Sep 2021
- First submitted
- 14 Sep 2018
- Last updated
- 20 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial on Estimating the Effect of Probiotic Strain Lactobacillus Reuteri DSM 17938 on Gut Microbiota Modulation in Infants Born by Caesarean Section
- ClinicalTrials.gov ID
- NCT03675048
- Acronym / sponsor ID
- CSUB0142
- Conditions
- Dysbiosis, Prophylaxis
- Keywords
- Gut Microbiota, Cesarean Section, Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 18 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.
The aim of this study is to assess influence of probiotic Lactobacillus reuteri DSM 17938 on formation of gut microbiota in infant born by Caesarean section. It is anticipated that daily using of probiotic Lactobacillus reuteri DSM 17938 can prevent development of early dysbiosis of gut microbiota induced by Caesarean section.
Detailed description
This is a single-center prospective randomized double-blind placebo-controlled clinical study. The planned duration of the study for each included infant will be 16 weeks, 4 weeks of study drug intake and 12 weeks of follow-up. 140 healthy infants born by Caesarean section will be included in the general group of the study, and 60 healthy infants born by natural vaginal delivery will be included in the control group. For infants included in the control group, all the same protocol requirements and procedures will be applied as for infants in the general group, except for randomization and the study product / placebo intake. Infants included in the general study group will be randomly assigned into the study product / placebo subgroups in 1: 1 ratio. During the study the gut microbiota will be analyzed. Feces samples should be collected no later than 72 hours after birth, and also on 14th day of life ± 3 days, 30th day of life ± 3 days and 112th day of life ± 3 days. Short-chain fatty acids (SCFA) will be analyzed in feces samples.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: BioGaia Protectis dropsThe intervention group will receive 5 drops (10^8 cfu Lactobacillus reuteri DSM 17938) twice daily during feeding for 4 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThe placebo group will receive 5 drops twice daily during feeding for 4 weeks. Placebo composition will be identical to that of the study drug but will not contain L. reuteri. |
| Control group | No intervention | –The infants from the control group will comply with the same requirements and will undergo the same procedures as participants from the main group except for randomization and treatment. |
Who may qualify
- Ages
- 0 to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- gestational age more than 37 weeks and less than 41 weeks
- age of enrolment is not more than 48 hours
- birth weight is corresponded to gestational age
- Apgar score ≥8 at 5 minutes
- Absence of congenital anomaly and/or clinical or physical abnormalities identified during clinical examination
Key exclusion criteria (8 listed)
- Chronic diseases or serious health problems of mother or child
- Gastrointestinal tract diseases of mother or child
- Delay in development
- Congenital abnormalities
- Intake of antibiotics by mother orally and / or vaginally during the last trimester of pregnancy
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 |
|---|---|---|
| BioGaia Protectis dropsAlso: BioGaia® Probiotic. Drops for babyfood supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938). | Dietary supplement | Intervention group |
| PlaceboContains same excipients as study drug, without the active ingredient L. Reuteri. | Dietary supplement | Placebo group |
Primary outcome
Composition of gut microbiota in infants born by Caesarean section
Time frame: 14 days
Composition of gut microbiota in infants born by Caesarean section in group received L. reuteri DSM 17938 versus placebo group at 14+/-3 day after delivery.
8 secondary outcomes
Composition of gut microbiota in infants born by vaginal delivery
Time frame: 14 days
Composition of gut microbiota in infants born by vaginal delivery
Time frame: 30 days
Composition of gut microbiota in infants born by Caesarean section
Time frame: 30 days
Composition of gut microbiota in infants born by Caesarean section
Time frame: 112 days (16 weeks)
Composition of gut microbiota in infants born by vaginal delivery
Time frame: 112 days (16 weeks)
Composition of short-chain fatty acids (SCFA) in infants born by vaginal delivery
Time frame: 14 days
Composition of short-chain fatty acids (SCFAs) in infants born by Caesarean section
Time frame: 14 days
Adverse events assessment
Time frame: 112 days (16 weeks)
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 20 Sep 2021.
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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 BioGaia Protectis drops in people with Dysbiosis and Prophylaxis, run by BioGaia AB at 1 site in Russia.
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 11 inclusion and 8 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 20 Sep 2021. 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 Russia. 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?
Composition of gut microbiota in infants born by Caesarean section (time frame: 14 days). 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 20 Sep 2021.