Insufficient Intestinal Microbiota Diversity After C-section BirthRESTORENCT02567071
Natural Microbiota Restoration After C-section Birth
A study testing perineal impregnated swab and clean swab in people with Insufficient Intestinal Microbiota Diversity After C-section Birth, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insufficient Intestinal Microbiota Diversity After C-section Birth
- What is being tested?
- perineal impregnated swab and clean swab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2016to Apr 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- over the age of legal majority
- delivery by planned C-section at term or vaginal delivery at term
- registered at a social security service
Who cannot join
- HIV or other STD patients
- immunocompromised patients
- known streptococcus B carriers
- known vaginal or perineal herpes infections
- chronic disease patients (obesity, diabetes, IBD)
- IMC before pregnancy > 30 kg/m²
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- antibiotic treatments one month before delivery
- emergency C-section
- Premature delivery (<37 amenorrhea weeks)
- hospitalized for more than one week before delivery
- known HVC infections
- for the newborns: every diagnosed anomaly
- patients who do not understand the research procedures or those that are institutionalized, or those unable to give informed consent
- patients deprived of ther liberty by legal or administrative decisions
- patients under an exclusion period from another study
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Gynécologie-Obstétrique, Groupe Hospitalier Pitié-Salpêtrière
Paris, 75013
About this study
Official title: Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne
The proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery.
The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.
- Being tested
- perineal impregnated swab, clean swab
- Keywords
- C-section, Microbiota
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal impregnated swabOther
After planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions.
clean swabOther
After planned C-section birth, newborns will suck on clean swab.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 75 children born by planned C-section will be exposed to the perineal microbiota of their mothers through perineal impregnated swab. Receives: Other: perineal impregnated swab |
| Placebo Group | Placebo comparator | 75 children born by planned C-section will be exposed to clean swab. Receives: Other: clean swab |
| Control Group | No intervention | 75 children born vaginally. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diversity of the intestinal microbiota
Intestinal microbiota diversity will be evluated through metagenomics.
Measured: 1 year
Secondary outcomes (1)
Health status
Health status of the newborn will be evaluated through questionnaries.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study start6 Apr 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insufficient Intestinal Microbiota Diversity After C-section BirthStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Jacky Nizard, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567071
- Sponsor's protocol ID
- C14-70
- Other IDs
- 2015-A00586-43
- Acronym
- RESTORE
- Status last verified
- Aug 2021
- First submitted
- 15 Sep 2015
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retablissement Du Microbiote Naturel Apres Naissance Par Cesarienne
- ClinicalTrials.gov ID
- NCT02567071
- Acronym / sponsor ID
- RESTORE / C14-70
- Keywords
- C-section, Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Apr 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 2 Oct 2015 (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 proportion of cesarean deliveries reached 30% of births in the US in 2008, while in the 1970s, it rarely reached 15%, as recommended by WHO. According to recent reports in some hospitals in China the use of cesarean section increased from 5% in the 1970s to over 60%. The use of C-section continues to grow in every countries of the world despite that current knowledge leads us to think that the vaginal birth, retained through millennia during mammalian evolution, guarantees the implementation of the best suited intestinal microbiota to build immunity and beneficial protective functions under the balanced mutual association between the host and its microbiota. Oral administration of a previously impregnated swab, by vaginal and maternal perineal secretions, following birth by planned C-section, would restore the normal development of the newborn intestinal microbiota mimicking exposure to these secretions during vaginal delivery.
The expected benefit is the establishment of a rich and diverse microbiota in individuals in the intervention group and by extension improving the overall health of these individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: perineal impregnated swab75 children born by planned C-section will be exposed to the perineal microbiota of their mothers through perineal impregnated swab. |
| Placebo Group | Placebo comparator | Other: clean swab75 children born by planned C-section will be exposed to clean swab. |
| Control Group | No intervention | –75 children born vaginally. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- over the age of legal majority
- delivery by planned C-section at term or vaginal delivery at term
- registered at a social security service
Key exclusion criteria (15 listed)
- HIV or other STD patients
- immunocompromised patients
- known streptococcus B carriers
- known vaginal or perineal herpes infections
- chronic disease patients (obesity, diabetes, IBD)
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 |
|---|---|---|
| perineal impregnated swabAfter planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions. | Other | Intervention Group |
| clean swabAfter planned C-section birth, newborns will suck on clean swab. | Other | Placebo Group |
Primary outcome
Diversity of the intestinal microbiota
Time frame: 1 year
Intestinal microbiota diversity will be evluated through metagenomics.
1 secondary outcome
Health status
Time frame: 1 year
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 24 Apr 2026.
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.
Jacky Nizard, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing perineal impregnated swab and clean swab in people with Insufficient Intestinal Microbiota Diversity After C-section Birth, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 3 inclusion and 15 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 24 Apr 2026. 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 France. 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?
Diversity of the intestinal microbiota (time frame: 1 year). 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 24 Apr 2026.