Comparison of Efficacy & Tolerability Of Polyethylene Glycol 4000 Versus Polyethylene Glycol 3350+ Electrolytes for Treatment of excessive stool loading in Children with Functional Constipatio

Phase 4

Conditions: Health Condition 1: K590- Constipation

Registration Number: CTRI/2024/03/063855

Lead Sponsor: Institute of Medical sciences (IMS) and SUM Hospitalk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

8) Patients having comorbidity of any other system like CVS/Respiratory/CNS etc

9)Known case of Chronic kidney disease or history of acute kidney injury in past 3 monthes

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects achieving fecal disimpaction in Each Arm <br/ ><br>Timepoint: 6 days from allocation of treatment or resolution of fecal impaction whichever is earlier <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Cumulative PEG dose required for fecal disimpaction in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is earlier;Proportion of subjects discontinuing the treatment due to palatability issues in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is earlier;Proportion of subjects reporting palatability issues in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is eariler;Total no of Days required to achieve fecal disimpaction in each armTimepoint: 6 days from treatment allocation/fecal impaction resolution whichever is earlier