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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
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neonatal Jaundice

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    October 5, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Chinese University of Hong Kong
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    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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