protocolSection identificationModule nctId: NCT06349031, orgStudyIdInfo id: IEC/IMS.SH/SOA/2024/683, briefTitle: Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-15, primaryCompletionDateStruct date: 2024-09-15, completionDateStruct date: 2024-09-15, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Institute of Medical Sciences and SUM Hospital, class: OTHER, descriptionModule briefSummary: Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In 90-95% of children, it is of functional origin. Thirty to seventy-five percent of children with functional constipation also have fecal impaction. The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements.Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents. The commonly used formulations are PEG 3350 with a molecular weight between 3200- 3700 g/mol and PEG 4000 with molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. PEG 3350 + Electrolyte (E) is more widely used than PEG 4000 for the management of constipation. This might be because of the perception that PEG 3350 + E is safer in terms of preventing electrolyte imbalance. However, because of the inclusion of electrolytes, PEG 3350+ E solution taste saltier than PEG 4000. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance. To date, no pediatric trials have compared PEG 4000 versus PEG 3350+E for management of Fecal disimpaction.Present study has been planned to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ E for fecal disimpaction in pediatric functional constipation. Patients between age 1-16 years having functional constipation (as per ROME IV criteria) with fecal impaction will be included. Subjects will be randomly assigned to either PEG 4000 or PEG 3350+E at a ratio of 1:1. They will be stratified into 3 different age groups: 1-5 years, 6-11 years, and 12-16 years. They will receive either of the PEG solutions (as per allocation) at a dose of 1.5 gm/kg/day for 6 consecutive days or till the resolution of fecal impaction whichever is earlier. The resolution of fecal impaction is defined as the passage of clear liquid stool and the disappearance of palpable abdominal fecolith.Primary outcome is defined as the proportion of subjects achieving fecal disimpaction in each arm.Secondary outcomes are defined as follows:1. Total no of Days required to achieve fecal disimpaction in each arm2. Cumulative dose of PEG required for fecal disimpaction in each arm3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm, conditionsModule conditions: Functional Constipation, conditions: Fecal Impaction, conditions: Constipation - Functional, conditions: Constipation Chronic Idiopathic, conditions: Pediatric Functional Constipation, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: One member of the research group will do the treatment allocation and will not be involved in clinical evaluation and collection of outcome data. Both study medications will be provided by him/her in opaque bottles with identical packaging and labeling. Neither the participants nor the rest of the study personnel will be aware of the treatment allocation., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants, interventions name: Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants, outcomesModule primaryOutcomes measure: Proportion of subjects achieving fecal disimpaction in Each Arm, secondaryOutcomes measure: Total no of Days required to achieve fecal disimpaction in each arm, secondaryOutcomes measure: Cumulative PEG dose required for fecal disimpaction in each arm, secondaryOutcomes measure: Proportion of subjects reporting palatability issues in each arm, secondaryOutcomes measure: Proportion of subjects discontinuing the treatment due to palatability issues in each arm, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Institute of Medical Sciences (IMS) and SUM Hospital, city: Bhubaneswar, state: Odisha, zip: 751003, country: India, contacts name: Kalpana Panda, MD, DM, role: CONTACT, phone: 91-9717133189, email: drkalpanapanda@gmail.com, contacts name: J Bikrant kumar Prusty, MD, role: CONTACT, phone: 91-9090205041, email: princejammy142@gmail.com, contacts name: Mrutunjay Dash, MD, role: SUB_INVESTIGATOR, contacts name: Basudev Biswal, MD, role: SUB_INVESTIGATOR, contacts name: Mamta Devi Mohanty, MD, role: SUB_INVESTIGATOR, contacts name: Prasant Saboth, MD, role: SUB_INVESTIGATOR, geoPoint lat: 20.27241, lon: 85.83385, hasResults: False