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Clinical Trials/CTRI/2024/03/063855
CTRI/2024/03/063855
Not Yet Recruiting
Phase 4

Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes For Fecal Disimpaction in Pediatric Functional Constipation: A Double-Blind Randomized Controlled Trial - NI

Institute of Medical sciences (IMS) and SUM Hospitalk0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: K590- Constipation
Sponsor
Institute of Medical sciences (IMS) and SUM Hospitalk
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Institute of Medical sciences (IMS) and SUM Hospitalk

Eligibility Criteria

Inclusion Criteria

  • 1\-16 years age admitted to the inpatient department
  • 2\. Having h/o functional constipation as per ROME IV criteria
  • 3\)with Fecal impaction defined as
  • A hard mass in the lower abdomen identified on physical examination or
  • Dilated rectum filled with large amount of stool on per rectal Examination or
  • Excessive stool in the colon on abdominal radiography as determined by a radiologist

Exclusion Criteria

  • 1\) Patients with drug\-induced constipation
  • 2\) Organic constipation ie,
  • I.Neurological disorders eg. Neural tube defects/cerebral/motor neuron diseases/neuro regression syndromes
  • II.Hirschsprung disease, or anal anomalies
  • III.Known metabolic or endocrine disorders
  • 3\) Patients with previous gastrointestinal surgery (except appendectomy)
  • 4\) Children with suspected gastrointestinal obstruction
  • 5\) Patients taking PEG (either at the time of enrolment or within 2 month before enrolment)
  • 6\) Patients receiving medication at enrolment or within 1 month before enrolment influencing gastrointestinal motility function (eg, lactulose, loperamide, cisapride)
  • 7\) Known history of Allergy to PEG formulations

Outcomes

Primary Outcomes

Not specified

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