Gut MicrobiotaNCT05086458
Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants
A study testing probiotics in people with Gut Microbiota, run by Shanghai 10th People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section. Read more about this study
- Who is it for?
- Ages 1 hour to 42 daysHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota
- What is being tested?
- probiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Aug 2021to 17 Oct 2021
- 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 1 hour to 42 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Neonates born by caesarean section
Who cannot join
- Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases With infectious diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Rong Yang
Shanghai, 20072
Rong Yang, MD, 13321917107, yangrongtongji@163.com
Huanlong Qin, PhD
About this study
Official title: Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants: an Open-label Single-center Randomized Parallel Controlled Study
The purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.
Read the detailed description
This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants born by cesarean section.
- Conditions
- Gut Microbiota
- Being tested
- probiotics
- Keywords
- gut microbiota, probiotics, infant, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsDietary supplement
probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | the patients in this arm will not receive probiotics. |
| Dietary Supplement | Experimental | the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks. Receives: Dietary Supplement: probiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gut microbiota at 42 days between no intervention group and experimental group.
Study the microbiota change of stool samples at 42 days between no intervention group and experimental group.
Measured: 42 days
Change in gut microbiota at 14 days between no intervention and experimental group.
Study the microbiota change of stool samples 14 days between no intervention group and experimental group.
Measured: 14 days
Secondary outcomes (1)
Change in gut microbiota at birth between no intervention and experimental group.
Study the microbiota change of stool samples at birth between no intervention group and experimental group.
Measured: birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start17 Aug 2021
- Primary completion17 Oct 2021 (estimated)
- Study completion17 Oct 2021 (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 Gut MicrobiotaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huanlong Qin, Shanghai 10th People's Hospital
- Investigators
- Huanlong Qin, MD, Principal investigator, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086458
- Sponsor's protocol ID
- SHSYEK-001
- Status last verified
- Oct 2021
- First submitted
- 18 Aug 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gong Y, Zhong H, Wang J, Wang X, Huang L, Zou Y, Qin H, Yang R. Effect of Probiotic Supplementation on the Gut Microbiota Composition of Infants Delivered by Cesarean Section: An Exploratory, Randomized, Open-label, Parallel-controlled Trial. Curr Microbiol. 2023 Sep 15;80(11):341. doi: 10.1007/s00284-023-03444-4.
PubMed 37712964
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Probiotics Supplement on the Gut Microbiota in Caesarean-born Infants: an Open-label Single-center Randomized Parallel Controlled Study
- ClinicalTrials.gov ID
- NCT05086458
- Acronym / sponsor ID
- SHSYEK-001
- Conditions
- Gut Microbiota
- Keywords
- gut microbiota, probiotics, infant, cesarean section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 17 Aug 2021 (actual)
- Primary completion
- 17 Oct 2021 (estimated)
- Study completion
- 17 Oct 2021 (estimated)
- First posted
- 21 Oct 2021 (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 purpose of this study is to evaluate the effect of probiotics on the gut microbiota of infants born by cesarean section.
Detailed description
This study aims to examine the impact of probiotics administration on the gut microbiota of infants born by cesarean section. Birth,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants born by cesarean section.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –the patients in this arm will not receive probiotics. |
| Dietary Supplement | Experimental | Dietary Supplement: probioticsthe patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis for 2 weeks. |
Who may qualify
- Ages
- 1 hour to 42 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Neonates born by caesarean section
Key exclusion criteria (1 listed)
- Gestational weeks <37 Birth weight <2500g or ≥4000g History of asphyxia anoxia at birth With congenital metabolic diseases or hereditary diseases With gastrointestinal diseases With infectious diseases
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 |
|---|---|---|
| probioticsprobiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis | Dietary supplement | Dietary Supplement |
Primary outcome
Change in gut microbiota at 42 days between no intervention group and experimental group.
Time frame: 42 days
Study the microbiota change of stool samples at 42 days between no intervention group and experimental group.
Change in gut microbiota at 14 days between no intervention and experimental group.
Time frame: 14 days
Study the microbiota change of stool samples 14 days between no intervention group and experimental group.
1 secondary outcome
Change in gut microbiota at birth between no intervention and experimental group.
Time frame: birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2021.
- Derived from this study: PubMed 37712964Gong Y, Zhong H, Wang J, Wang X, Huang L, Zou Y, Qin H, Yang R. Effect of Probiotic Supplementation on the Gut Microbiota Composition of Infants Delivered by Cesarean Section: An Exploratory, Randomized, Open-label, Parallel-controlled Trial. Curr Microbiol. 2023 Sep 15;80(11):341. doi: 10.1007/s00284-023-03444-4.
- Individual participant dataSharing planned: No
Related trials for Gut Microbiota
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Active, not recruiting
SweetSpot - The Effect of Non-nutritive Sweeteners on Health
Healthy Adult
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Recruiting
The Effect of a Synbiotic on Intestinal Barrier Function and Microbiota Modulation in Middle-aged to Elderly Individuals
Gastrointestinal Microbiome (Focus), Gastrointestinal Symptoms
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.
Huanlong Qin, MD principal investigator
Shanghai 10th People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Gut Microbiota, run by Shanghai 10th People's Hospital at 1 site in China.
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 1 inclusion and 1 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 21 Oct 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 China. 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. 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?
Contact Rong Yang, MD (13321917107, yangrongtongji@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gut microbiota at 42 days between no intervention group and experimental group. (time frame: 42 days). 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?
On the ClinicalTrials.gov record for NCT05086458, 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 21 Oct 2021.