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Investigation of the Effect of Lactase Drops on Infantile Colic

Efficacy of lactase drops in infant colic

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241130063897N1
Enrollment
136
Registered
2025-05-05
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

Infant colic.

Interventions

Intervention 1: Intervention group: For infants who are breastfed, mothers will be instructed to pour 10 milliliters of foremilk, which contains the highest lactose concentration, into a teaspoon or a

Sponsors

Gorgan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Days to 3 Months

Inclusion criteria

Inclusion criteria: Infants (under 3 months old) who meet the Rome IV diagnostic criteria for infantile colic Absence of acute and chronic illness Breastfeeding

Exclusion criteria

Exclusion criteria: Incomplete consumption of the prescribed medication Infants born before completing 34 weeks of gestation or with a birth weight under 2500 grams and insufficient weight gain of less than 125 grams per week will be excluded from the trial. Infants with known gastrointestinal disorders, previous abdominal surgery, known galactosemia, or diabetes mellitus will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The intended outcome is the effect of lactase drops on reducing the duration of crying in infants. Timepoint: Infants will also be invited on days 7, 14, and 21 during the treatment period, and at each visit, a specialist will assess the infant's symptoms and weight. Method of measurement: How to measure the outcome variable: The duration of the child's crying during the treatment period is recorded by the parents using a designed checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ehsan Alaee

Gorgan University of Medical Sciences

dralaei@goums.ac.ir+98 17 3243 0310

Outcome results

None listed

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