probiotics in neonates with withdrawal symptoms

Investigating the role of probiotics in the incidence and severity of withdrawal symptoms in neonates born from drug addict mothers

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250426065475N1

Enrollment

Registered

2025-05-29

Start date

2025-05-22

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Neonates with withdrawal syndrome.

Interventions

Intervention 1: Intervention group: Baby girls and boys with withdrawal syndrome. Intervention 2: Control group: Baby girls and boys with withdrawal syndrome.

Eligibility

Sex/Gender

All

Age

1 Days to 30 Days

Inclusion criteria

Inclusion criteria: Neonates born from mothers addicted to drugs during pregnancy, who are admitted to the neonatal unit with a diagnosis of NAS.

Exclusion criteria

Exclusion criteria: Parental disapproval The baby's vital signs are unstable.

Design outcomes

Primary

Measure	Time frame
Determining the role of probiotics on the severity of withdrawal symptoms (neurological, digestive, and breastfeeding) in infants born from addicted mothers. Timepoint: In infants with NAS, in addition to conventional drug therapy (morphine at a dose of 50 micrograms/weight per dose every three hours), an appropriate dose of probiotic containing the organism Lactobacillus reuteri will be prescribed as 5 drops of probiotic as a single dose once a day from the onset of the infant's symptoms according to the FNASS table/scoring system and Finnegan score until discharge and improvement of withdrawal symptoms according to the FNASS table and Finnegan score less than 8. Method of measurement: Review of the neonatal drug abstinence scoring system, also called the Finningan score. Before and after giving probiotics.	—

Measure

Time frame

Determining the role of probiotics on the severity of withdrawal symptoms (neurological, digestive, and breastfeeding) in infants born from addicted mothers. Timepoint: In infants with NAS, in addition to conventional drug therapy (morphine at a dose of 50 micrograms/weight per dose every three hours), an appropriate dose of probiotic containing the organism Lactobacillus reuteri will be prescribed as 5 drops of probiotic as a single dose once a day from the onset of the infant's symptoms according to the FNASS table/scoring system and Finnegan score until discharge and improvement of withdrawal symptoms according to the FNASS table and Finnegan score less than 8. Method of measurement: Review of the neonatal drug abstinence scoring system, also called the Finningan score. Before and after giving probiotics.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactSara Amini

Mashhad University of Medical Sciences

aminis@mums.ac.ir+98 51 3881 8605

Outcome results

None listed

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