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Comparison of Polyethylene glycol 3350 and 4000 in children with chronic constipation

A comparative study of Polyethylene glycol 3350 and 4000 in the treatment of functional constipation in children aged 4-18 years:A randomised controlled trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041995
Enrollment
90
Registered
2022-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: Polyethylene Glycol 3350 /4000: One group will receive PEG 4000/3350 using Sequentially Numbered Opaque Sealed Envelope (SNOSE) Technique at dose of 0.4-0.8gm/kg/day in 1-2 divided dose

Sponsors

Dr SNIGDHA
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Duration of more than 4 weeks for all ages . Presence of >=2 of the following : 1) Defecation frequency 2) Fecal incontinence >=1 times per week after the acquisition of toileting skills , 3) history of excessive stool retention ( retentive posture, stool witholding behaviour) 4) history of painful or hard bowel movements , 5) presence of a large mass in the rectum or on per abdomen examination 6) history of large diameter stools that may obstruct the toilet.

Exclusion criteria

Exclusion criteria: (Based on History , Physical Examination and Exclusion of Red Flags) 1) Motility related disorders -Hirschprung disease 2) Congenital anomalies -Anal stenosis , anteriorly displaced Anus,spinal cord anomalies( tethered cord , spina bifida) 3) Devlopmental defect -mental retardation , autism OR cerebral palsy 4) use of PEG with 2 months before inclusion or concurrent use of other drugs influencing gastrointestinal motility -opiates, anticholinergic agents,phenobarbitone,vincristine.

Design outcomes

Primary

MeasureTime frame
Stool frequency per weekTimepoint: over the 24 weeks of treatment

Secondary

MeasureTime frame
1)Stool consistency ( According to Bristol stool chart , Type 3 and beyond ) 2)Frequency of pain or difficulty in passing stools (no of episodes per week ) 3)Frequency of soiling episodes (no. of episodes per week) 4)Compliance with the preparation ( 80% of the prescribed dose) 5)side effects like nausea,diarrhea , abdominal pain 6)use of any rescue therapyTimepoint: over the 24 weeks of treatment

Countries

India

Contacts

Public ContactSnigdha

Eras Lucknow Medical College

drshrishbhatnagar@gmail.com9918208555

Outcome results

None listed

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