Neonatal JaundicePhase 2NCT06087874
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
A Phase 2 study testing Vivomixx® in people with Neonatal Jaundice and Microtia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Jaundice, Microtia, Pregnancy Related
- What is being tested?
- Vivomixx®
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Mar 2024to Jun 2025
- Phase
- Phase 2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All pregnant women aged 18-45 years old.
- Gestational age of 28-34 weeks
- Normal singleton pregnancy
Who cannot join
- Foetal abnormality
- Mothers with antibiotic medication during the allocation
- Couples with glucose 6-phosphate dehydrogenase enzyme deficiency
- Couples with known rhesus or haemolytic disease history
- Plan of place of birth at other hospitals other than Prince of Wales Hospital
- known breast disorder or any contraindication for breastfeeding.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong, New Territories, 0852
Bekalu K Alemu, bekalukassie@link.cuhk.edu.hk
About this study
Official title: Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. Vivomixx®-probiotic product will be used as treatment and placebo as a control.
Read the detailed description
Neonatal jaundice is a yellowish discoloration of the skin and sclera because of over-concentration of circulating unconjugated bilirubin (hyperbilirubinemia) in the body. It can lead the baby to severe complications including death. Intestinal flora modulation by probiotics administration to the mother may tackle this problem. Therefore, investigators designed a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group). Eligible pregnant women will be recruited voluntarily at 28-36 weeks of gestation and allocated randomly to either the probiotic group (Vivomixx®) or placebo group (maltose-containing unit) which are phenotypically similar. Participants will take one sachet of the product per day starting from 36 weeks of gestation until the end of first week of postpartum. Biological samples (maternal stool, breast milk, and neonatal faeces) will be collected at different time points. Additionally, neonatal transcutaneous bilirubin will be measured on the second and seventh day of life using a Drager Meter (a transcutaneous bilirubinometer). The microbial DNA will be extracted from biological samples using commercial kits and metagenomics sequencing will be employed and will be correlated with bilirubin level using appropriate statistical methods. This study will be conducted based on the Helsinki Declaration and International Council for Harmonization Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.100-T. Written informed consent will be obtained from each participant during enrolment.
- Being tested
- Vivomixx®, Placebo
- Medical subject headings
- Jaundice, Neonatal, Congenital Microtia, Hyperbilirubinemia, Neonatal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivomixx®Dietary supplement
The probiotic group participants will receive 1 sachet of probiotic product daily from 36weeks of gestation up to 7th day of postpartum while placebo groups will 1 sachet placebo prepared with the same colour, taste, and packaging with Vivomixx® daily for the same duration of probiotic groups. Vivomixx® is a non-genetically modified (GMO), gluten-free, high potency microbiotic food supplement, containing eight strains (Streptococcus thermophilus DSM24731® / NCIMB 30438, Bifidobacterium breve DSM24732® / NCIMB 30441, Bifidobacterium longum DSM24736® / NCIMB 30435, Bifidobacterium infantis DSM24737® / NCIMB 30436*, Lactobacillus acidophilus DSM24735® / NCIMB 30442, Lactobacillus plantarum DSM24730® / NCIMB 30437, Lactobacillus paracasei DSM24733® / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM24734® / NCIMB 30440) of live bacteria (450 billion bacteria per sachet).
PlaceboDietary supplement
A maltose- containing product with a similar phenotype with Vivomixx®.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics | Experimental | Vivomixx® is a multi-strain probiotics product. Receives: Dietary Supplement: Vivomixx® |
| Placebo | Placebo comparator | Maltose-containing placebo product Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyperbilirubinemia
Investigators will measure the transcutaneous bilirubin level on the second and seventh day of life and plot the record on the nomograph. The record above the 95th percentile will be taken as considerable hyperbilirubinemia and then the baby will be investigated for total serum bilirubin measurement if needed to declare hyperbilirubinemia. The outcome will be classified as hyperbilirubinemia and non-hyperbilirubinemia.
Measured: 1 week since birth
Transcutaneous bilirubin level
Infant's skin bilirubin level on the chest measured using a non-invasive devise called Drager meter. It will be measured in milligram per decilitre or micromole per liter. This outcome will be measured as a continuous outcome.
Measured: 1 week of life (after birth)
Secondary outcomes (7)
Preterm birth
This will be measured using the gestational age at birth
Measured: within two days of birth
Number of participants with Initiation of labor
Spontaneous initiation of induction of labour
Measured: within two days of birth
Mode of birth checklist
Spontaneous vaginal delivery, assisted birth or cesarean section
Measured: within two days of birth
Birth weight
Weight of the baby at birth in grams
Measured: within two days of birth
Apgar scores
First and fifth-minute Apgar scores of babies
Measured: within two days of birth
Breast milk microbiome profile
Breast milk samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.
Measured: From birth seventh day of postpartum
Stool microbiome profile
maternal and infant stool samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.
Measured: From birth seventh day of postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start23 Mar 2024
- Primary completionFeb 2025 (estimated)
- Study completionJun 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 Neonatal JaundiceStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald Wang, Chinese University of Hong Kong
- Investigators
- Chi C Wang, Professor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06087874
- Sponsor's protocol ID
- 20230317
- Status last verified
- May 2024
- First submitted
- 5 Oct 2023
- Last updated
- 20 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be included in publications of findings as a supplementary file. It will be available to anyone based on official request from the principal investigator.
Publications
Alemu BK, Lee MW, Leung MBW, Lee WF, Wang Y, Wang CC, Lau SL. Preventive effect of prenatal maternal oral probiotic supplementation on neonatal jaundice (POPS Study): A protocol for the randomised double-blind placebo-controlled clinical trial. BMJ Open. 2024 Jun 8;14(6):e083641. doi: 10.1136/bmjopen-2023-083641.
PubMed 38851232
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
- ClinicalTrials.gov ID
- NCT06087874
- Acronym / sponsor ID
- 20230317
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Oct 2023 (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.
This is a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group) to investigate the effect of maternal perinatal probiotic supplementation on neonatal jaundice, breast milk microbiome, maternal stool, and infant fecal microbiome. Vivomixx®-probiotic product will be used as treatment and placebo as a control.
Detailed description
Neonatal jaundice is a yellowish discoloration of the skin and sclera because of over-concentration of circulating unconjugated bilirubin (hyperbilirubinemia) in the body. It can lead the baby to severe complications including death. Intestinal flora modulation by probiotics administration to the mother may tackle this problem. Therefore, investigators designed a randomized double-blind placebo-controlled parallel group superiority clinical trial among 94 pregnant women (47 in each group). Eligible pregnant women will be recruited voluntarily at 28-36 weeks of gestation and allocated randomly to either the probiotic group (Vivomixx®) or placebo group (maltose-containing unit) which are phenotypically similar. Participants will take one sachet of the product per day starting from 36 weeks of gestation until the end of first week of postpartum. Biological samples (maternal stool, breast milk, and neonatal faeces) will be collected at different time points. Additionally, neonatal transcutaneous bilirubin will be measured on the second and seventh day of life using a Drager Meter (a transcutaneous bilirubinometer). The microbial DNA will be extracted from biological samples using commercial kits and metagenomics sequencing will be employed and will be correlated with bilirubin level using appropriate statistical methods. This study will be conducted based on the Helsinki Declaration and International Council for Harmonization Requirements for Pharmaceuticals for Human Use (ICH) Guideline for Good Clinical Practice (GCP) standards. Ethical approval is obtained from the Joint Chinese University of Hong Kong and New Territories East Cluster (CUHK-NTEC) Clinical Research Ethics Committee, Hong Kong with reference number: 2023.100-T. Written informed consent will be obtained from each participant during enrolment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics | Experimental | Dietary Supplement: Vivomixx®Vivomixx® is a multi-strain probiotics product. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMaltose-containing placebo product |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- All pregnant women aged 18-45 years old.
- Gestational age of 28-34 weeks
- Normal singleton pregnancy
Key exclusion criteria (6 listed)
- Foetal abnormality
- Mothers with antibiotic medication during the allocation
- Couples with glucose 6-phosphate dehydrogenase enzyme deficiency
- Couples with known rhesus or haemolytic disease history
- Plan of place of birth at other hospitals other than Prince of Wales Hospital
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 |
|---|---|---|
| Vivomixx®The probiotic group participants will receive 1 sachet of probiotic product daily from 36weeks of gestation up to 7th day of postpartum while placebo groups will 1 sachet placebo prepared with the same colour, taste, and packaging with Vivomixx® daily for the same duration of probiotic groups. Vivomixx® is a non-genetically modified (GMO), gluten-free, high potency microbiotic food supplement, containing eight strains (Streptococcus thermophilus DSM24731® / NCIMB 30438, Bifidobacterium breve DSM24732® / NCIMB 30441, Bifidobacterium longum DSM24736® / NCIMB 30435, Bifidobacterium infantis DSM24737® / NCIMB 30436*, Lactobacillus acidophilus DSM24735® / NCIMB 30442, Lactobacillus plantarum DSM24730® / NCIMB 30437, Lactobacillus paracasei DSM24733® / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM24734® / NCIMB 30440) of live bacteria (450 billion bacteria per sachet). | Dietary supplement | Probiotics |
| PlaceboA maltose- containing product with a similar phenotype with Vivomixx®. | Dietary supplement | Placebo |
Primary outcome
Hyperbilirubinemia
Time frame: 1 week since birth
Investigators will measure the transcutaneous bilirubin level on the second and seventh day of life and plot the record on the nomograph. The record above the 95th percentile will be taken as considerable hyperbilirubinemia and then the baby will be investigated for total serum bilirubin measurement if needed to declare hyperbilirubinemia. The outcome will be classified as hyperbilirubinemia and non-hyperbilirubinemia.
Transcutaneous bilirubin level
Time frame: 1 week of life (after birth)
Infant's skin bilirubin level on the chest measured using a non-invasive devise called Drager meter. It will be measured in milligram per decilitre or micromole per liter. This outcome will be measured as a continuous outcome.
7 secondary outcomes
Preterm birth
Time frame: within two days of birth
Number of participants with Initiation of labor
Time frame: within two days of birth
Mode of birth checklist
Time frame: within two days of birth
Birth weight
Time frame: within two days of birth
Apgar scores
Time frame: within two days of birth
Breast milk microbiome profile
Time frame: From birth seventh day of postpartum
Stool microbiome profile
Time frame: From birth seventh day of postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Derived from this study: PubMed 38851232Alemu BK, Lee MW, Leung MBW, Lee WF, Wang Y, Wang CC, Lau SL. Preventive effect of prenatal maternal oral probiotic supplementation on neonatal jaundice (POPS Study): A protocol for the randomised double-blind placebo-controlled clinical trial. BMJ Open. 2024 Jun 8;14(6):e083641. doi: 10.1136/bmjopen-2023-083641.
- Individual participant dataSharing planned: Yes. Individual participant data will be included in publications of findings as a supplementary file. It will be available to anyone based on official request from the principal investigator.
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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.
Chi C Wang, Professor principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vivomixx® in people with Neonatal Jaundice and Microtia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 6 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 20 May 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 Hong Kong. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Bekalu K Alemu ((852) 63506068, bekalukassie@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyperbilirubinemia (time frame: 1 week since birth). 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 NCT06087874, 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 20 May 2024.