Effect of probiotic consumption versus placebo in lactating mothers with low birth weight or very low birth weight infants on weight gain, serum bilirubin level and the incidence of necrotizing enterocolitis

Effect of probiotic consumption versus placebo in lactating mothers with low birth weight or very low birth weight infants on weight gain, serum bilirubin level and the incidence of necrotizing enterocolitis: a triple-blind randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120215009014N466

Enrollment

Registered

2023-03-30

Start date

2023-04-04

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Low birth weight. Extremely low birth weight newborn

Interventions

Intervention 1: Intervention group: Oral Kidilact sachet (probiotic + prebiotic) 1 gr once daily for 28 days. Intervention 2: Control group: Oral placebo (starch) sachet once daily for 28 days.

Eligibility

Sex/Gender

Female

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Age of 15 to 45 years Mothers with low birth weight or very low birth weight infants

Exclusion criteria

Exclusion criteria: A baby who is not able to feed with breast milk

Design outcomes

Primary

Measure	Time frame
The mean weight of the newborns. Timepoint: Before the intervention and on the 14th and 28th days after the intervention. Method of measurement: Using weights.;The mean serum bilirubin level of newborns. Timepoint: Before the intervention and on the 14th and 28th days after the intervention. Method of measurement: Using a laboratory test.	—

Secondary

Measure	Time frame
Occurrence of necrotizing enterocolitis. Timepoint: 28 days after the intervention. Method of measurement: By taking history and clinical examination.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Sharaflari

Hamedan University of Medical Sciences

sarasharaflari@gmail.com+98 81 3838 0572

Outcome results

None listed

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