Skip to content

Clinical study of probiotics for jaundice neonate during phototherapy based on gene and metabonomics

Clinical study of probiotics for jaundice neonate during phototherapy based on gene and metabonomics

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036013
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

jaundice

Interventions

Full term infant breast feeding group jaundice group:Addition of probiotics
Prrterm infant breast feeding group jaundice group:Addition of probiotics
Full term infantformular feeding group jaundice group:Addition of probiotics
Preterm infant formular feeding group jaundice group:Addition of probiotics
Full term infantbreast and formular feeding group jaundice group:Addition of probiotics
Preterm infantbreast and formular feeding group jaundice group:Addition of probiotics

Sponsors

East Hospital of Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 1 Years

Inclusion criteria

Inclusion criteria: 1. Full term infants gestational age 37 to 42 weeks; preterm infants gestational age 32 to 37 weeks; 2. day age <=2 weeks; 3. full term infant's birth weight 2500g to 4000g; premature infant's birth weight 1500g to 2500g; 4. no antibiotic micro and ecological preparation was used before collection; 5. mother was in good health during pregnancy, had no history of special drug use, and did not take it before, during and after delivery In addition, antibiotics and probiotics were used; 6. breast feeding or artificial feeding were selected before admission; 7. probiotics screening experimental group: neonatal pathological jaundice defined in "practical neonatology" only needed light treatment (admitted to the hospital); probiotics screening control group was jaundice at the same gestational age, but not enough phototherapy indications, and continued outpatient dynamic follow-up Children with jaundice were interviewed; 8. Clinical trial application of probiotics: the experimental group and the control group were those with pathological jaundice defined in "practical neonatology" and only needed light treatment (admitted to the hospital), and then they were randomly divided into experimental group and control group according to the principle of digital random control.

Exclusion criteria

Exclusion criteria: 1. bilirubin level up to exchange transfusion standard; direct bilirubin increase; 2. pneumonia, sepsis and other diseases; 3. severe immune deficiency; 4. genetic metabolic disease; 5. congenital biliary tract malformation or other organ malformation; 6. drug allergy; 7. antibiotics after admission And probiotics.

Design outcomes

Primary

MeasureTime frame
Occurrence of side effects in clinical phototherapy;

Secondary

MeasureTime frame
Jaundice index;Changes of intestinal flora and metabolism in children;

Countries

China

Contacts

Public ContactJINPING ZHANG
zhang-jin-ping@163.com+86 18017579729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026