Investigating the effect of probiotics on neonatal jaundice

Investigating the effect of probiotic supplements on hyperbilirubinemia in term neonates

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230816059167N1

Enrollment

Registered

2023-08-21

Start date

2023-08-23

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Neonatal hyperbilirubinemia. Neonatal jaundice, unspecified

Interventions

Intervention 1: 1st Intervention group: Once daily and each time 5 drops of probiotic supplement containing Lactobacillus Reuteri prepared by Fara Daru Fanavar Mehr (Farabiotic) pharmaceutical company

Eligibility

Sex/Gender

All

Age

1 Days to 14 Days

Inclusion criteria

Inclusion criteria: 35 to 42 weeks of gestation Birth weight between 10th and 90th percentile Newborns aged from birth to 14 days Hyperbilirubinemia based on Bhutani Nomogram

Exclusion criteria

Exclusion criteria: Unwillingness to cooperate (lack of parental consent) Taking antibiotics Any acute or active infection Occurrence of any side effects Not consuming breast milk exclusively Thyroid disorders Presence of respiratory distress NICU admission Congenital heart disease The presence of hemolysis, hemoglobinopathies, and hemolytic blood diseases such as G6PD deficiency, blood group incompatibility Cephal hematoma and subgaleal hemorrhage Phenobarbital consumption by the mother in the last month of pregnancy Non-physiological hyperbilirubinemia Presence of a life-threatening congenital disorder Blood exchange Outpatient treatment

Design outcomes

Primary

Measure	Time frame
Total Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum total bilirubin (mg/mL).;Direct Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum direct bilirubin (mg/mL).;Indirect Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum indirect bilirubin (mg/mL).	—

Measure

Time frame

Total Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum total bilirubin (mg/mL).;Direct Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum direct bilirubin (mg/mL).;Indirect Bilirubin. Timepoint: At the beginning of the study and 24, 48, 72 and 96 hours after the intervention. Method of measurement: Serum indirect bilirubin (mg/mL).

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Secondary

Measure	Time frame
Length of hospital stay. Timepoint: At the time of discharge. Method of measurement: Days.;Defecation. Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: Number of defecations per day.;Complications including allergic reactions, gastrointestinal complications and . Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: History taking and physical examination.	—

Measure

Time frame

Length of hospital stay. Timepoint: At the time of discharge. Method of measurement: Days.;Defecation. Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: Number of defecations per day.;Complications including allergic reactions, gastrointestinal complications and . Timepoint: on a daily basis from the day the intervention started until 96 hours later. Method of measurement: History taking and physical examination.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyyed Ramin Madani

Kashan University of Medical Sciences

drraminmadani@gmail.com+98 31 5554 0026

Outcome results

None listed

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