Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice

Pregnancy Related Clinical Trial

Official title:

Preventive Effect of Perinatal Oral Probiotic Supplementation (POPS) on Neonatal Jaundice: A Randomized Double-Blind Placebo-Controlled Parallel-Group Superiority Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06087874
• Other study ID #: 20230317
• Status: Recruiting
• Phase: Phase 2
• Start date: March 23, 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Chinese University of Hong Kong
• Contact: Bekalu K Alemu
• Phone: (852) 63506068
• Email: bekalukassie[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Vivomixx®-probiotic product will be used as treatment and placebo as a control.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: June 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal
• Jaundice
• Jaundice, Neonatal
• Microtia
• Neonatal Jaundice
• Pregnancy Related

Intervention

Dietary Supplement:
• 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).
• Placebo
A maltose- containing product with a similar phenotype with Vivomixx®.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	New Territories

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with Skin rash	any allergic reaction	From initiation of the intervention until 1 week postpartum
Other	Number of participants with Diarrhea	Frequent loose of stool	From initiation of the intervention until 1 week postpartum
Other	Number of participants with Abdominal bloating	Any distention, gas (flatulence) and cramp on the abdomen	From initiation of the intervention until 1 week postpartum
Primary	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.	1 week since birth
Primary	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.	1 week of life (after birth)
Secondary	Preterm birth	This will be measured using the gestational age at birth	within two days of birth
Secondary	Number of participants with Initiation of labor	Spontaneous initiation of induction of labour	within two days of birth
Secondary	Mode of birth checklist	Spontaneous vaginal delivery, assisted birth or cesarean section	within two days of birth
Secondary	Birth weight	Weight of the baby at birth in grams	within two days of birth
Secondary	Apgar scores	First and fifth-minute Apgar scores of babies	within two days of birth
Secondary	Breast milk microbiome profile	Breast milk samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.	From birth seventh day of postpartum
Secondary	Stool microbiome profile	maternal and infant stool samples will be collected, bacterial DNA collected and meta-genomic sequencing will be carried out.	From birth seventh day of postpartum

External Links

•   Intervention product details.