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A study to compare safety and efficacy of Polyethylene glycol (PEG 3350) and Lactulose for treating functional constipation in children (1-4years)

COMPARISON OF POLYETHYLENE GLYCOL (PEG 3350) AND LACTULOSE IN FUNCTIONAL CONSTIPATION IN CHILDREN(1-4years);DOUBLE BLINDED-RANDOMISED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/01/039517
Enrollment
70
Registered
2022-01-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system

Interventions

Intervention1: Polyethylene glycol (3350): 2ml/kg in two divided doses, oral Control Intervention1: Lactulose: 2ml/kg in two divided doses, oral

Sponsors

Geetanjali Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children (1to 4years) with functional constipation (newly as well as previously diagnosed). 2. Rome IV criteria are used to define functional constipation for children from 1 to 4 years of age.

Exclusion criteria

Exclusion criteria: 1. Children with organic cause(s) of constipation 2. Refusal for consent.

Design outcomes

Primary

MeasureTime frame
relief in constipationTimepoint: at 4, 8 and 12 weeks—

Secondary

MeasureTime frame
Safety and efficacy of both drugTimepoint: at 4,8 and 12 weeks—

Countries

India

Contacts

Public ContactDr Anjali Vyas

Geetanjali Medical College and Hospital

drmandot@yahoo.com9462022900

Outcome results

None listed

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