Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 15, 2024

Primary Completion Date

September 15, 2024

Study Completion Date

September 15, 2024

Conditions
Functional ConstipationFecal ImpactionConstipation - FunctionalConstipation Chronic IdiopathicPediatric Functional Constipation
Interventions
DRUG

Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants

As per treatment allocation, PEG 4000 will be administered to participants at a dose of 1.5 gm/kg/day dissolved in water until resolution of fecal impaction or a maximum till 6 days whichever is earlier. Fecal impaction Resolution is defined as : Passage of clear liquid stool and no palpable abdominal fecolith

DRUG

Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants

As per treatment allocation, PEG 3350 + Electrolytes will be administered to participants at a dose of 1.5 gm/kg/day dissolved in water until resolution of fecal impaction or a maximum till 6 days whichever is earlier. Fecal impaction Resolution is defined as : Passage of clear liquid stool and no palpable abdominal fecolith

Trial Locations (1)

751003

Institute of Medical Sciences (IMS) and SUM Hospital, Bhubaneswar

All Listed Sponsors
lead

Institute of Medical Sciences and SUM Hospital

OTHER

NCT06349031 - Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction | Biotech Hunter | Biotech Hunter