A Phase 2 interventional study of Vivomixx® and Placebo in Neonatal Jaundice, Microtia and Pregnancy Related, sponsored by Chinese University of Hong Kong. Recruiting at 1 site in Hong Kong. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Prevention
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.
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.
110 studies on the registry are indexed under Jaundice, Neonatal; 28 are open to participants now.
This study's planned enrollment of 94 is below the median of 150 across 78 interventional studies indexed under Jaundice, Neonatal.
Browse Jaundice, Neonatal studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vivomixx® is a multi-strain probiotics product.
Dietary Supplement: Vivomixx®
Maltose-containing placebo product
Dietary Supplement: Placebo
Drug pages: Streptococcus thermophilus · Bifidobacterium breve · Bifidobacterium animalis subsp. lactis · Lacteol · Lactobacillus plantarum · Lacticaseibacillus paracasei · Lactobacillus helveticus
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).
A maltose- containing product with a similar phenotype with Vivomixx®.
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.
Time frame: 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.
Time frame: 1 week of life (after birth)
Preterm birth
This will be measured using the gestational age at birth
Time frame: within two days of birth
Number of participants with Initiation of labor
Spontaneous initiation of induction of labour
Time frame: within two days of birth
Mode of birth checklist
Spontaneous vaginal delivery, assisted birth or cesarean section
Time frame: within two days of birth
Birth weight
Weight of the baby at birth in grams
Time frame: within two days of birth
Apgar scores
First and fifth-minute Apgar scores of babies
Time frame: 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.
Time frame: 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.
Time frame: From birth seventh day of postpartum
Number of participants with Skin rash
any allergic reaction
Time frame: From initiation of the intervention until 1 week postpartum
Number of participants with Diarrhea
Frequent loose of stool
Time frame: From initiation of the intervention until 1 week postpartum
Number of participants with Abdominal bloating
Any distention, gas (flatulence) and cramp on the abdomen
Time frame: From initiation of the intervention until 1 week postpartum
Plan to share: 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.
Supporting information: Study protocol
Time frame: One year after initiation of the study
Access criteria: official request and memorandum of understanding signing
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Feb 2025, 11 months after the start.
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Studies of the drugs tested here: Streptococcus thermophilus · Bifidobacterium breve · Bifidobacterium animalis subsp. lactis · Lacteol · Lactobacillus plantarum · Lacticaseibacillus paracasei · Lactobacillus helveticus
Chinese University of Hong Kong →