PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their PregnancyNCT05554185
Probiotic Supplementation During Pregnancy in Preeclampsia High-risk Groups
A study testing aspirin 100mg and probiotics 1 bag in people with PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy, run by Nanfang Hospital, Southern Medical University.
Trial summary
In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
- What is being tested?
- aspirin 100mg and probiotics 1 bag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 338 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2022to 31 Dec 2024
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- PE high-risk population aged 18-50 years with gut microbiota dysbiosis
- No severe cardiopulmonary diseases
- No severe hepatic and renal insufficiency
- No severe active infection
- Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism
- No diseases affecting intestinal microecology
Show all 9Show fewer
- No history of smoking and drinking
- The researchers evaluated those pregnant women expected to deliver more than 20 weeks
- Voluntarily participate in this clinical study and sign the informed consent form
Who cannot join
- With severe cardiopulmonary, hepatic and renal insufficiency
- With uncontrolled active infections 2 weeks before enrollment
- Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism
- with diseases affecting intestinal microecology
- Smoking and drinking history
- With acute gastrointestinal ulcer
- Hemorrhagic constitution
- Other discomfort assessed by the investigato
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Probiotic Supplementation During Pregnancy on Maternal and Infant Outcomes in Preeclampsia High-risk Groups Based on Abnormal Intestinal Flora: a Randomized Controlled Clinical Trial
In this randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.
- Conditions
- PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
- Being tested
- aspirin 100mg and probiotics 1 bag
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirin 100mg and probiotics 1 bagDietary supplement
taking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery.
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | aspirin 100mg and probiotics 1 bag Receives: Dietary Supplement: aspirin 100mg and probiotics 1 bag |
| group B | Placebo comparator | aspirin 100mg and placebo1 bag Receives: Dietary Supplement: aspirin 100mg and probiotics 1 bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of preeclampsia
After 20 weeks of pregnancy, systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg, accompanied by any of the following items: urinary protein ≥ 0.3g/24h, or urinary protein / creatinine ratio ≥ 0.3,or random urinary protein ≥ (+) (examination method for unconditional protein quantification); Non-albuminuria can be accompanied by any kind of organ or system involvement: heart, lung, liver, kidney and other important organs, or abnormal changes in blood system, digestive system, nervous system, placenta-fetus, etc.
Measured: From being recruited to 6 weeks after delivery
Secondary outcomes (1)
The incidence of fetal growth restriction
due to the influence of pathological factors such as mother, fetus and placenta, fetal growth does not reach its due genetic potential, which is characterized by fetal body weight or abdominal circumference estimated by ultrasound lower than the 10th percentile of the corresponding gestational age
Measured: From being recruited to 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start21 Sep 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (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 PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their PregnancyStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 338 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554185
- Sponsor's protocol ID
- NFEC-2022-358
- Status last verified
- Sep 2022
- First submitted
- 21 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Li P, Liu M, Zheng H, He Y, Chen MX, Tang W, Yue X, Huang Y, Zhuang L, Wang Z, Zhong M, Ke G, Hu H, Feng Y, Chen Y, Yu Y, Zhou H, Huang L. Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation. Gut. 2020 Mar;69(3):513-522. doi: 10.1136/gutjnl-2019-319101. Epub 2020 Jan 3.
PubMed 31900289
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Probiotic Supplementation During Pregnancy on Maternal and Infant Outcomes in Preeclampsia High-risk Groups Based on Abnormal Intestinal Flora: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05554185
- Acronym / sponsor ID
- NFEC-2022-358
- Conditions
- PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 338 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 21 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 26 Sep 2022 (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 randomized controlled study, preventive intervention of aspirin combined with probiotics or aspirin combined with placebo would given to PE (pre-eclampsia) high-risk population with gut microbiota dysbiosis during their pregnancy, and finally assess the efficacy and safety of aspirin combined with probiotics to prevent PE.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Dietary Supplement: aspirin 100mg and probiotics 1 bagaspirin 100mg and probiotics 1 bag |
| group B | Placebo comparator | Dietary Supplement: aspirin 100mg and probiotics 1 bagaspirin 100mg and placebo1 bag |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- PE high-risk population aged 18-50 years with gut microbiota dysbiosis
- No severe cardiopulmonary diseases
- No severe hepatic and renal insufficiency
- No severe active infection
- Pregnant women did not take antibiotics or antifungal drugs 30 days before fecal sample collection; No probiotic preparation was taken 2 weeks before sample collection; Never take drugs that may interfere with glucose and lipid metabolism
Key exclusion criteria (8 listed)
- With severe cardiopulmonary, hepatic and renal insufficiency
- With uncontrolled active infections 2 weeks before enrollment
- Subjects took antibiotics or antifungal drugs 30 days before sample collection; Take probiotics 2 weeks before sample collection; Have taken drugs that may interfere with glucose and lipid metabolism
- with diseases affecting intestinal microecology
- Smoking and drinking history
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 |
|---|---|---|
| aspirin 100mg and probiotics 1 bagtaking aspirin 100mg and probiotics 1 bag per day from 14-16 weeks of pregnancy until 35 + 6 weeks of pregnancy or emergency delivery. | Dietary supplement | group A, group B |
Primary outcome
The incidence of preeclampsia
Time frame: From being recruited to 6 weeks after delivery
After 20 weeks of pregnancy, systolic blood pressure ≥ 140mmHg and / or diastolic blood pressure ≥ 90mmHg, accompanied by any of the following items: urinary protein ≥ 0.3g/24h, or urinary protein / creatinine ratio ≥ 0.3,or random urinary protein ≥ (+) (examination method for unconditional protein quantification); Non-albuminuria can be accompanied by any kind of organ or system involvement: heart, lung, liver, kidney and other important organs, or abnormal changes in blood system, digestive system, nervous system, placenta-fetus, etc.
1 secondary outcome
The incidence of fetal growth restriction
Time frame: From being recruited to 6 weeks after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Results publication: PubMed 31900289Chen X, Li P, Liu M, Zheng H, He Y, Chen MX, Tang W, Yue X, Huang Y, Zhuang L, Wang Z, Zhong M, Ke G, Hu H, Feng Y, Chen Y, Yu Y, Zhou H, Huang L. Gut dysbiosis induces the development of pre-eclampsia through bacterial translocation. Gut. 2020 Mar;69(3):513-522. doi: 10.1136/gutjnl-2019-319101. Epub 2020 Jan 3.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing aspirin 100mg and probiotics 1 bag in people with PE (Pre-eclampsia) High-risk Population With Gut Microbiota Dysbiosis During Their Pregnancy, run by Nanfang Hospital, Southern Medical University.
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 9 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: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Yichi Zhang (18774562132, 1525683944@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of preeclampsia (time frame: From being recruited to 6 weeks after delivery). 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 NCT05554185, 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 26 Sep 2022.