Lactase enzyme drops use in infant colic

To study the clinical efficacy of lactase enzyme supplementation in infant colic - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/06/068617

Enrollment

120

Registered

2024-06-10

Start date

Unknown

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

Health Condition 1: R109- Unspecified abdominal pain

Interventions

Intervention1: Supplementation of lactase enzyme: 5 drops of lactase enzyme 4 times a day before feed for 4 weeks Control Intervention1: Placebo: 5 drops of placebo 4 times a day orally before every f

Eligibility

Inclusion criteria

Inclusion criteria: crying more than 3 hours a day for atleast 3 days a week and for more than 3 weeks

Exclusion criteria

Exclusion criteria: Infants born before completing 34 weeks of gestation Infants weighing less than 2500g Infants with history of trauma Infants with gastrointestinal disorders Infants with previous abdominal surgery Infants with history of fever Failure to thrive infants Infants with respiratory illness

Design outcomes

Secondary

Measure	Time frame
Comparing the adverse effects after 4 weeks of lactase enzyme supplementationTimepoint: 4 weeks	—

Primary

Measure	Time frame
To study the clinical efficacy of lactase enzyme supplementation in infant colic in terms of improvement in duration of baby cry period .Timepoint: 4weeks	—

Countries

India

Contacts

Public ContactDr Prabha KhaireMore

Government Medical College And Hospital Aurangabad

pmorekhaire@rediffmail.com9850947118

Outcome results

None listed

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