Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
Primary Purpose
Neonatal Jaundice, Microtia, Pregnancy Related
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vivomixx®
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Neonatal Jaundice
Eligibility Criteria
Inclusion Criteria: All pregnant women aged 18-45 years old. Gestational age of 28-34 weeks Normal singleton pregnancy Exclusion Criteria: 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Probiotics
Placebo
Arm Description
Vivomixx® is a multi-strain probiotics product.
Maltose-containing placebo product
Outcomes
Primary Outcome Measures
Neonatal Jaundice
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 jaundice and then the physician in charge will declare the diagnosis by clinical evaluation and total serum bilirubin measurement if needed. The outcome will be classified as jaundiced or non-jaundice.
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.
Secondary Outcome Measures
Preterm birth
This will be measured using the gestational age at birth
Number of participants with Initiation of labor
Spontaneous initiation of induction of labour
Mode of birth checklist
Spontaneous vaginal delivery, assisted birth or cesarean section
Birth weight
Weight of the baby at birth in grams
Apgar scores
First and fifth-minute Apgar scores of babies
Breast milk microbiome profile
Breast milk samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.
Stool microbiome profile
maternal and infant stool samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.
Full Information
NCT ID
NCT06087874
First Posted
October 5, 2023
Last Updated
October 17, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT06087874
Brief Title
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
Official Title
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Jaundice, Microtia, Pregnancy Related
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
It is a double-blind study
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Probiotics
Arm Type
Experimental
Arm Description
Vivomixx® is a multi-strain probiotics product.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltose-containing placebo product
Intervention Type
Dietary Supplement
Intervention Name(s)
Vivomixx®
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
A maltose- containing product with a similar phenotype with Vivomixx®.
Primary Outcome Measure Information:
Title
Neonatal Jaundice
Description
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 jaundice and then the physician in charge will declare the diagnosis by clinical evaluation and total serum bilirubin measurement if needed. The outcome will be classified as jaundiced or non-jaundice.
Time Frame
1 week since birth
Title
Transcutaneous bilirubin level
Description
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.
Time Frame
1 week of life (after birth)
Secondary Outcome Measure Information:
Title
Preterm birth
Description
This will be measured using the gestational age at birth
Time Frame
within two days of birth
Title
Number of participants with Initiation of labor
Description
Spontaneous initiation of induction of labour
Time Frame
within two days of birth
Title
Mode of birth checklist
Description
Spontaneous vaginal delivery, assisted birth or cesarean section
Time Frame
within two days of birth
Title
Birth weight
Description
Weight of the baby at birth in grams
Time Frame
within two days of birth
Title
Apgar scores
Description
First and fifth-minute Apgar scores of babies
Time Frame
within two days of birth
Title
Breast milk microbiome profile
Description
Breast milk samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.
Time Frame
From birth seventh day of postpartum
Title
Stool microbiome profile
Description
maternal and infant stool samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.
Time Frame
From birth seventh day of postpartum
Other Pre-specified Outcome Measures:
Title
Number of participants with Skin rash
Description
any allergic reaction
Time Frame
From initiation of the intervention until 1 week postpartum
Title
Number of participants with Diarrhea
Description
Frequent loose of stool
Time Frame
From initiation of the intervention until 1 week postpartum
Title
Number of participants with Abdominal bloating
Description
Any distention, gas (flatulence) and cramp on the abdomen
Time Frame
From initiation of the intervention until 1 week postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All pregnant women aged 18-45 years old.
Gestational age of 28-34 weeks
Normal singleton pregnancy
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
One year after initiation of the study
IPD Sharing Access Criteria
official request and memorandum of understanding signing
Links:
URL
https://www.vivomixx.eu/en/2017/09/04/vivomixx-450-billion/
Description
Intervention product details.
Learn more about this trial
Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice
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