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Clinical study on the development of probiotics beneficial for alleviating neonatal jaundice based on breast milk microbiota

Clinical study on the development of probiotics beneficial for alleviating neonatal jaundice based on breast milk microbiota

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076544
Enrollment
Unknown
Registered
2023-10-11
Start date
2023-11-01
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Neonatal jaundice

Interventions

Control group:Oral placebo
Health group:None
Jaundice group:None

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Term infants are 37 <= gestational age < 42 weeks; 2. The newborns were dynamically followed up from the 3rd day after birth to the 7th day, 14th day and 28th day; 3. Full-term infants weigh 2,500 g <= birth weight < 4,000 g; 4. None of the newborns used antibiotics (all antibiotics) and micro-ecological agents (including bifidobacteria and lactic acid bacteria) during the experiment; 5. The mother is healthy during pregnancy, has no history of using special drugs, and has not taken antibiotics and microecological agents before, during and after delivery (within 28 days); 6. Select the children who were exclusively breastfed before admission and their nursing mothers.

Exclusion criteria

Exclusion criteria: 1. The bilirubin level (mainly direct bilirubin) is increased; 2. Patients with pneumonia, septicemia and other diseases; 3. People with severe immunodeficiency; 4. Those with hereditary metabolic diseases; 5. Those with congenital biliary tract malformation or other organ malformations; 6. Those who are allergic to test strains or to auxiliary materials.

Design outcomes

Primary

MeasureTime frame
bilirubin;Breast milk flora;Intestinal flora;

Countries

China

Contacts

Public ContactZhang Jinping

Shanghai Sixth People's Hospital

zhang-jin-ping@163.com+86 180 1757 9729

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026