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The study compares two commonly used medicines to see which baby with colic cry less and feel more comfortable

Effect of Probiotics versus Probiotics combined with simethicone in the Management of Infantile Colic - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105287
Enrollment
80
Registered
2026-03-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Nil: Nil

Sponsors

Manthri Lochana Latha Sree
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Term infants more than or equal to 37 weeks of gestation Infants age between 0-12 months Infants diagnosed with Infantile colic based on Wessel s criteria Crying more than 3 hours per day more than 3days per week more than 3 consecutive weeks Term Infants and birth weight more than 2.5 kg Exclusively or predominantly breastfed infants Parents or guardians willing to participate and give written informed consent

Exclusion criteria

Exclusion criteria: Preterm infants Infants with underlying gastrointestinal, metabolic, or neurological disorders Infants receiving antibiotics, probiotics, or simethicone in the past 7 days Known hypersensitivity to study medications

Design outcomes

Primary

MeasureTime frame
Reduction in daily duration and frequency of crying episodes in infants with colic after 7 days of treatment.Timepoint: AT 7 TH DAY—

Secondary

MeasureTime frame
Time to symptomatic relief & caregiver satisfaction (5-point Likert scale), assessed during follow-ups on days 14 & 28.Timepoint: AT 14 & 28 th day—

Countries

India

Contacts

Public ContactT Bharath Kumar

Sri Manakula Vinayagar Medical College

scooby_25575@yahoo.com9003468873

Outcome results

None listed

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