Fecal Microbiota TransplantationMT-SECFLORNCT04173208
Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
A study testing Fecal microbial transplant in people with Fecal Microbiota Transplantation and Cesarean Section, Affecting Fetus or Newborn, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. 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
- Fecal Microbiota Transplantation, Cesarean Section, Affecting Fetus or Newborn, Intestinal Microbiome
- What is being tested?
- Fecal microbial transplant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFinland
- Study dates
- 10 Nov 2019to 31 Jan 2025
- 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
- non-eventful pregnancy
- planned elective CS
- Finnish language competency
Who cannot join
- Mother:
- maternal refusal
- positive findings in screening samples
- maternal antibiotic treatment within 4 weeks of delivery (excluding the antibiotic given immediately prior to clamping of the umbilical cord)
- travel outside European Union during 3 months prior to delivery
- CS after the onset of labor (non-elective CS)
Show all 11Show fewer
- Newborn:
- birth below 37 weeks of gestation
- Apgar score of less than 8
- disturbances of neonatal adaptation (such as transient tachypnea of the newborn)
- antibiotic treatment of the newborn before discharge
Trial locations and contacts
1 site in 1 country.
Finland1 site
Children's Hospital, Helsinki University Hospital, Pediatric Research Center
Helsinki, Uusimaa, 00029
About this study
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome.
Read the detailed description
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. After faecal microbiota transfer, the children are followed for 24 months for the evaluation of markers of, for example, atopy-related diseases, and changes in immunomarkers associated with the transfer.
- Conditions
- Fecal Microbiota Transplantation, Cesarean Section, Affecting Fetus or Newborn, Intestinal Microbiome
- Being tested
- Fecal microbial transplant, Placebo
- Keywords
- Transplant, Cesarean section, inflammatory response, Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbial transplantOther
Fecal microbial transplant
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbial transplant | Experimental | The participants of the experimental arm will receive an oral fecal microbial transplant after delivery Receives: Other: Fecal microbial transplant |
| Placebo group | Placebo comparator | The participants of the placebo arm will receive an oral placebo after delivery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age
Measured: At three months of age
Secondary outcomes (4)
Difference in markers of cow milk immunoglobulin Es
The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.
Measured: At 12 months of age
Difference in markers of aeroallergen immunoglobulin Es
The difference in markers of allergen-specific immunoglobulin Es between the intervention group and the placebo group.
Measured: At 24 months of age
Difference in tetanus and measles, mumps and rubella vaccine responses
The difference in vaccine responses between the intervention group and the placebo group (as Immunoglobulin G milli-International Units/milliliter).
Measured: At 12 and 24 months of age
Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age
Measured: At 6, 12 and 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start10 Nov 2019
- Primary completion16 Jan 2024
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fecal Microbiota TransplantationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Number of enrolled mothers describes the number of mothers included for screening.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki
- Responsible party
- Principal investigator, Otto Helve, Helsinki University Central Hospital
- Investigators
- Otto Helve, MD, PhD, Principal investigator, Children's Hospital, Helsinki University Hospital and the University of Helsinki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173208
- Sponsor's protocol ID
- MT-SECFLOR
- Acronym
- MT-SECFLOR
- Status last verified
- Jan 2024
- First submitted
- 25 Apr 2019
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Carpen N, Brodin P, de Vos WM, Salonen A, Kolho KL, Andersson S, Helve O. Transplantation of maternal intestinal flora to the newborn after elective cesarean section (SECFLOR): study protocol for a double blinded randomized controlled trial. BMC Pediatr. 2022 Sep 29;22(1):565. doi: 10.1186/s12887-022-03609-3.
PubMed 36175995
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Main Trial of the Cesarean Section and Intestinal Flora of the Newborn Study
- ClinicalTrials.gov ID
- NCT04173208
- Acronym / sponsor ID
- MT-SECFLOR / MT-SECFLOR
- Conditions
- Fecal Microbiota Transplantation, Cesarean Section, Affecting Fetus or Newborn, Intestinal Microbiome
- Keywords
- Transplant, Cesarean section, inflammatory response, Infant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- University of Helsinki
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 21 Nov 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.
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome.
Detailed description
In this study the investigators assess whether, in CS-delivered infants, the intestinal microbiome could be successfully and safely normalised by postnatal oral transfer of maternal fecal microbiome. After faecal microbiota transfer, the children are followed for 24 months for the evaluation of markers of, for example, atopy-related diseases, and changes in immunomarkers associated with the transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Number of enrolled mothers describes the number of mothers included for screening.
| Arm | Type | Receives |
|---|---|---|
| Fecal microbial transplant | Experimental | Other: Fecal microbial transplantThe participants of the experimental arm will receive an oral fecal microbial transplant after delivery |
| Placebo group | Placebo comparator | Other: PlaceboThe participants of the placebo arm will receive an oral placebo after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- non-eventful pregnancy
- planned elective CS
- Finnish language competency
Key exclusion criteria (11 listed)
- maternal refusal
- positive findings in screening samples
- maternal antibiotic treatment within 4 weeks of delivery (excluding the antibiotic given immediately prior to clamping of the umbilical cord)
- travel outside European Union during 3 months prior to delivery
- CS after the onset of labor (non-elective CS)
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 |
|---|---|---|
| Fecal microbial transplantFecal microbial transplant | Other | Fecal microbial transplant |
| PlaceboPlacebo | Other | Placebo group |
Primary outcome
Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
Time frame: At three months of age
Developmental trajectory of the intestinal microbiota, assessed with 16s rRNA gene amplicon and shotgun sequencing of fecal DNA to determine the changes in the intestinal microbiota composition, diversity and functionality from birth to three months of age
4 secondary outcomes
Difference in markers of cow milk immunoglobulin Es
Time frame: At 12 months of age
Difference in markers of aeroallergen immunoglobulin Es
Time frame: At 24 months of age
Difference in tetanus and measles, mumps and rubella vaccine responses
Time frame: At 12 and 24 months of age
Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing
Time frame: At 6, 12 and 24 months of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Derived from this study: PubMed 36175995Carpen N, Brodin P, de Vos WM, Salonen A, Kolho KL, Andersson S, Helve O. Transplantation of maternal intestinal flora to the newborn after elective cesarean section (SECFLOR): study protocol for a double blinded randomized controlled trial. BMC Pediatr. 2022 Sep 29;22(1):565. doi: 10.1186/s12887-022-03609-3.
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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.
Otto Helve, MD, PhD principal investigator
Children's Hospital, Helsinki University Hospital and the University of Helsinki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbial transplant in people with Fecal Microbiota Transplantation and Cesarean Section, Affecting Fetus or Newborn, run by Helsinki University Central Hospital at 1 site in Finland.
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 11 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 1 Feb 2024. 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 Finland. 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?
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?
Longitudinal change of intestinal microbiota assessed with 16S rRNA and shotgun sequencing (time frame: At three months of age). 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 NCT04173208, which also lists 1 linked publication.
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 1 Feb 2024.