C-sectionNCT03834415
Lactobacillus Reuteri DSM17938 in C-Section Infants
A study testing Lactobacillus reuteri DSM17038 in people with C-section, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.
Trial summary
RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section Read more about this study
- Who is it for?
- Ages 12 to 36 hours
- Conditions the study is for
- C-section
- What is being tested?
- Lactobacillus reuteri DSM17038
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteMexico
- Study dates
- 8 Feb 2019to 18 Jun 2019
- 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 12 to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age >37weeks +0 days and <39 weeks +0 days
- Birth weight appropriate for gestational age (AGA) or Large for Gestational Age (LGA)
- Apgar score 8 or greater
- Children will receive more than 50% of the feeding occasions with human breastmilk
- Mothers will have the intention to exclusively or predominantly breastfeed the subject. On the diary report form mother will report day by day the frequency of human lactation and the frequency and amount of infant formula.
- Readiness and the opportunity for parents to fill out a study diary, questionnaires.
- Parent(s) are willing to postpone major changes in the infant feeding mode, and
- Written informed consent from parents
Who cannot join
- Older than 24 hours after birth when given the first dose of investigational product
- Any kind of chronic or acute diseases during pregnancy that can modify fecal microbiota in children, e.g. gestational diabetes, pre-clampsia, gastrointestinal disease
- Congenital malformations or anomalies
- Maternal use of antibiotics from gestational week 33 and throughout the study period.
- Maternal use of probiotics from gestational week 33 and throughout the study period.
- Maternal severe obesity at inclusion or at delivery evaluated using Rosso Madrones centiles
Show all 12Show fewer
- Infant use of antibiotics throughout the study period.
- Infant use of probiotics throughout the study period, including infant formula and/or supplementation.
- Infants carrying out general anesthesia
- Meconium aspiration syndrome
- History of premature disruption of membranes for >24h
- Participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital General Dr. Manuel Gea Gonzalez
Mexico City, Tlalpan, 14080
About this study
Official title: Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study
RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section
Read the detailed description
RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.
- Conditions
- C-section
- Being tested
- Lactobacillus reuteri DSM17038, Placebo for Probiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus reuteri DSM17038Dietary supplement
Oil drops of L. reuteri containing 1x10>8 CFU
Placebo for ProbioticsOther
Oil drops mimicking in consistency and flavor to experimental product
| Study group | Role | What they receive |
|---|---|---|
| Lactobacillus reuteri DSM17038 | Experimental | Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days Receives: Dietary Supplement: Lactobacillus reuteri DSM17038 |
| Placebo probiotics | Placebo comparator | Placebo for probiotics, pols drops similar in consistency and flavor as experimental product Receives: Other: Placebo for Probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on fecal microbiome diversity at day 14
Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Measured: 14 days
Changes on fecal microbiome abundance at day 14
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Measured: 14 days
Changes on fecal microbiome stability at day 14
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Measured: 14 days
Secondary outcomes (5)
Changes on fecal microbiome diversity at day 7, 30 and 60
Changes on abundance evaluated by Channon Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention
Measured: 7, 30 and 60 days
Changes on fecal microbiome abundance at day 7, 30 and 60
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention
Measured: 7, 30 and 60 days
Changes on fecal microbiome stability at day 7, 30 and 60
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 7, 30 and 60 after intervention
Measured: 7, 30 and 60 days
Changes on Salivary IgA levels
Levels of salivary IgA after 7,30 and 60 days after intervention
Measured: 7, 30 and 60 days
Frequency of Adverse Event
Frequency of adverse events reported after randomization and until finish the treatment (day 30)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start8 Feb 2019
- Primary completion18 Apr 2019
- Study completion18 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for C-sectionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT two arms to evaluate the safety and efficacy of L. reuteri vs. placebo to modulate the microbiome gut profile in newborn babies delivered by C-section
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en Salud
- Sponsor type
- University, hospital or other
- Collaborators
- BioGaia AB
- Responsible party
- Principal investigator, Pedro Gutierrez Castrellon, Innovacion y Desarrollo de Estrategias en Salud
- Investigators
- Pedro Gutierrez Castrellon, MD, MSc, DSc, Principal investigator, Hospital General Dr. Manuel Gea Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03834415
- Sponsor's protocol ID
- CSUB0153
- Status last verified
- Jun 2019
- First submitted
- 5 Feb 2019
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Protocol documents and data base results will be available at international sites
Publications
Chandel DS, Perez-Munoz ME, Yu F, Boissy R, Satpathy R, Misra PR, Sharma N, Chaudhry R, Parida S, Peterson DA, Gewolb IH, Panigrahi P. Changes in the Gut Microbiota After Early Administration of Oral Synbiotics to Young Infants in India. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):218-224. doi: 10.1097/MPG.0000000000001522.
PubMed 28121648Garcia Rodenas CL, Lepage M, Ngom-Bru C, Fotiou A, Papagaroufalis K, Berger B. Effect of Formula Containing Lactobacillus reuteri DSM 17938 on Fecal Microbiota of Infants Born by Cesarean-Section. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):681-687. doi: 10.1097/MPG.0000000000001198.
PubMed 27035371Nitert MD, Barrett HL, Foxcroft K, Tremellen A, Wilkinson S, Lingwood B, Tobin JM, McSweeney C, O'Rourke P, McIntyre HD, Callaway LK. SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women. BMC Pregnancy Childbirth. 2013 Feb 25;13:50. doi: 10.1186/1471-2393-13-50.
PubMed 23442391Jansman AJ, Zhang J, Koopmans SJ, Dekker RA, Smidt H. Effects of a simple or a complex starter microbiota on intestinal microbiota composition in caesarean derived piglets. J Anim Sci. 2012 Dec;90 Suppl 4:433-5. doi: 10.2527/jas.53850.
PubMed 23365401Kuitunen M, Kukkonen K, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Haahtela T, Savilahti E. Probiotics prevent IgE-associated allergy until age 5 years in cesarean-delivered children but not in the total cohort. J Allergy Clin Immunol. 2009 Feb;123(2):335-41. doi: 10.1016/j.jaci.2008.11.019. Epub 2009 Jan 8.
PubMed 19135235
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Lactobacillus Reuteri DSM17938 on Early Gut Microbial Colonization in Infants Born by Caesarean Section: A Double-blinded, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT03834415
- Acronym / sponsor ID
- CSUB0153
- Conditions
- C-section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Innovacion y Desarrollo de Estrategias en SaludUniversity, hospital or other
- Collaborators
- BioGaia AB
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 18 Apr 2019 (actual)
- Study completion
- 18 Jun 2019 (actual)
- First posted
- 8 Feb 2019 (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.
RCT designed to evaluate the impact of Lactobacillus reuteri DSM17938 to modify gut microbiota in children delivered by C-section
Detailed description
RCT designed to evaluate the safety and efficacy of L. reuteri DSM17938 administrated to newborns babies to modify the fecal microbiome after 30 days of supplementation. Secondary Secondary endpoints will be evaluate the occurrence and frequency of AEs Day 0 to Day 60; The gut bacterial composition Day 7 and Day 30 as described in primary endpoint; the gut bacterial composition in infants born by c-section and supplemented with L. reuteri DSM17938 compared to the gut bacterial composition in infants born vaginally and the salivary concentration of IgA at 48h ±3h after birth and at Day 30.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- RCT two arms to evaluate the safety and efficacy of L. reuteri vs. placebo to modulate the microbiome gut profile in newborn babies delivered by C-section
| Arm | Type | Receives |
|---|---|---|
| Lactobacillus reuteri DSM17038 | Experimental | Dietary Supplement: Lactobacillus reuteri DSM17038Lactobacillus reuteri DSM17038, 1x108 CFU once a day for 30 days |
| Placebo probiotics | Placebo comparator | Other: Placebo for ProbioticsPlacebo for probiotics, pols drops similar in consistency and flavor as experimental product |
Who may qualify
- Ages
- 12 to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Gestational age >37weeks +0 days and <39 weeks +0 days
- Birth weight appropriate for gestational age (AGA) or Large for Gestational Age (LGA)
- Apgar score 8 or greater
- Children will receive more than 50% of the feeding occasions with human breastmilk
- Mothers will have the intention to exclusively or predominantly breastfeed the subject. On the diary report form mother will report day by day the frequency of human lactation and the frequency and amount of infant formula.
Key exclusion criteria (12 listed)
- Older than 24 hours after birth when given the first dose of investigational product
- Any kind of chronic or acute diseases during pregnancy that can modify fecal microbiota in children, e.g. gestational diabetes, pre-clampsia, gastrointestinal disease
- Congenital malformations or anomalies
- Maternal use of antibiotics from gestational week 33 and throughout the study period.
- Maternal use of probiotics from gestational week 33 and throughout the study period.
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 DSM17038Oil drops of L. reuteri containing 1x10>8 CFU | Dietary supplement | Lactobacillus reuteri DSM17038 |
| Placebo for ProbioticsOil drops mimicking in consistency and flavor to experimental product | Other | Placebo probiotics |
Primary outcome
Changes on fecal microbiome diversity at day 14
Time frame: 14 days
Changes on diversity evaluated by Shannon Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Changes on fecal microbiome abundance at day 14
Time frame: 14 days
Changes on abundance evaluated by Simpson Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
Changes on fecal microbiome stability at day 14
Time frame: 14 days
Changes on stability evaluated by Chao Index of firmicutes, bacteroidetes and actinobacteria at day 14 after intervention
5 secondary outcomes
Changes on fecal microbiome diversity at day 7, 30 and 60
Time frame: 7, 30 and 60 days
Changes on fecal microbiome abundance at day 7, 30 and 60
Time frame: 7, 30 and 60 days
Changes on fecal microbiome stability at day 7, 30 and 60
Time frame: 7, 30 and 60 days
Changes on Salivary IgA levels
Time frame: 7, 30 and 60 days
Frequency of Adverse Event
Time frame: 30 days
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 Jun 2019.
- Background: PubMed 28121648Chandel DS, Perez-Munoz ME, Yu F, Boissy R, Satpathy R, Misra PR, Sharma N, Chaudhry R, Parida S, Peterson DA, Gewolb IH, Panigrahi P. Changes in the Gut Microbiota After Early Administration of Oral Synbiotics to Young Infants in India. J Pediatr Gastroenterol Nutr. 2017 Aug;65(2):218-224. doi: 10.1097/MPG.0000000000001522.
- Background: PubMed 27035371Garcia Rodenas CL, Lepage M, Ngom-Bru C, Fotiou A, Papagaroufalis K, Berger B. Effect of Formula Containing Lactobacillus reuteri DSM 17938 on Fecal Microbiota of Infants Born by Cesarean-Section. J Pediatr Gastroenterol Nutr. 2016 Dec;63(6):681-687. doi: 10.1097/MPG.0000000000001198.
- Background: PubMed 23442391Nitert MD, Barrett HL, Foxcroft K, Tremellen A, Wilkinson S, Lingwood B, Tobin JM, McSweeney C, O'Rourke P, McIntyre HD, Callaway LK. SPRING: an RCT study of probiotics in the prevention of gestational diabetes mellitus in overweight and obese women. BMC Pregnancy Childbirth. 2013 Feb 25;13:50. doi: 10.1186/1471-2393-13-50.
- Background: PubMed 23365401Jansman AJ, Zhang J, Koopmans SJ, Dekker RA, Smidt H. Effects of a simple or a complex starter microbiota on intestinal microbiota composition in caesarean derived piglets. J Anim Sci. 2012 Dec;90 Suppl 4:433-5. doi: 10.2527/jas.53850.
- Background: PubMed 19135235Kuitunen M, Kukkonen K, Juntunen-Backman K, Korpela R, Poussa T, Tuure T, Haahtela T, Savilahti E. Probiotics prevent IgE-associated allergy until age 5 years in cesarean-delivered children but not in the total cohort. J Allergy Clin Immunol. 2009 Feb;123(2):335-41. doi: 10.1016/j.jaci.2008.11.019. Epub 2009 Jan 8.
- Individual participant dataSharing planned: Yes. Protocol documents and data base results will be available at international sites
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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.
Pedro Gutierrez Castrellon, MD, MSc, DSc principal investigator
Hospital General Dr. Manuel Gea Gonzalez
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 DSM17038 in people with C-section, run by Innovacion y Desarrollo de Estrategias en Salud at 1 site in Mexico.
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 8 inclusion and 12 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 Jun 2019. 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 Mexico. 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?
Changes on fecal microbiome diversity at day 14 (time frame: 14 days). The study lists 3 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 NCT03834415, which also lists 5 linked publications.
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 Jun 2019.