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A study to evaluate the role of laxatives in childhood foreign body ingestion

A study to evaluate the efficacy and safety of laxatives (Polyethylene glycol) vs placebo in pediatric foreign body ingestion: A randomized controlled trial - NIL

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064508
Enrollment
148
Registered
2024-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Health Condition 1: K929- Disease of digestive system, unspecified

Interventions

Intervention1: Active drug (Syrup Polyethylene glycol): Syrup Polyethylene glycol will be administered at a dose of 1g/kg/day in two divided doses. The syrup used would have a concentration of 52.5g/1

Sponsors

Bangalore Medical College and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children presenting with ingestion of foreign body to the Department of Pediatric Surgery, Bangalore Medical College and Research Institute.

Exclusion criteria

Exclusion criteria: 1. Children with features of intestinal obstruction or perforation peritonitis. 2. Children with esophageal foreign body, multiple magnets, magnet and a metal, biologically active foreign body, radiolucent foreign body, or impacted foreign body. 3. Children with history of gastrointestinal pathology or gastrointestinal surgery. 4. Children with phenylketonuria or seizure disorder.

Design outcomes

Primary

MeasureTime frame
Rate of passage of ingested foreign bodyTimepoint: At the time of presentation, at 7 days, 14 days, 28 days, and monthly till the passage of foreign body.

Secondary

MeasureTime frame
Need for invasive interventionTimepoint: On admission and on follow-up;Occurrence of adverse eventsTimepoint: On follow-up

Countries

India

Contacts

Public ContactVeerabhadra R

Bangalore Medical College and Research Institute

vbrps2016@gmail.com9901021289

Outcome results

None listed

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