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

NCT06349031 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IEC/IMS.SH/SOA/2024/683
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Total no of Days required to achieve fecal disimpaction in each arm
2. 2.Cumulative dose of PEG required for fecal disimpaction in each arm
3. 3.Proportion of subjects (\> 5 years age) reporting palatability issues in each arm
4. 4.Proportion of subjects discontinuing the treatment due to palatability issues in each arm

Conditions

Functional Constipation; Fecal Impaction; Constipation - Functional; Constipation Chronic Idiopathic; Pediatric Functional Constipation

Keywords

Functional constipation; Fecal disimpaction; pediatric; Polyethelene glycol 3350; Polyethylene glycol 4000

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving fecal disimpaction in Each Arm

  The proportion of subjects achieving fecal disimpaction in Each Arm

  6 days from allocation of treatment or resolution of fecal impaction whichever is earlier

Secondary Outcomes (4)

• Total no of Days required to achieve fecal disimpaction in each arm

  6 days from allocation of treatment or resolution of fecal impaction whichever is earlier

• Cumulative PEG dose required for fecal disimpaction in each arm

  6 days from allocation of treatment or resolution of fecal impaction whichever is earlier

• Proportion of subjects reporting palatability issues in each arm

  6 days from allocation of treatment or resolution of fecal impaction whichever is earlier

• Proportion of subjects discontinuing the treatment due to palatability issues in each arm

  6 days from allocation of treatment or resolution of fecal impaction whichever is earlier

Study Arms (2)

Polyethylene glycol (PEG) 3350 +Electrolytes ARM

ACTIVE COMPARATOR

\[PEG 33500+Electrolyte\] will be administered 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

Polyethylene glycol (PEG) 4000 ARM

EXPERIMENTAL

PEG 4000 will be administered 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) 4000 as per treatment allocation to participants

Interventions

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

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

Polyethylene glycol (PEG) 4000 ARM

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

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

Polyethylene glycol (PEG) 3350 +Electrolytes ARM

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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

You may not qualify if:

• Patients with drug-induced constipation
• 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
• Patients with previous gastrointestinal surgery (except appendectomy)
• Children with suspected gastrointestinal obstruction
• Patients taking PEG (either at the time of enrolment or within 2 month before enrolment)
• Patients receiving medication at enrolment or within 1 month before enrolment influencing gastrointestinal motility function (eg, lactulose, loperamide, cisapride)
• Known history of Allergy to PEG formulations
• Patients having comorbidity of any other system like CVS/Respiratory/CNS etc
• Known case of Chronic kidney disease or history of acute kidney injury in past 3 monthes

Sponsors & Collaborators

• Institute of Medical Sciences and SUM Hospital: lead

Study Sites (1)

Institute of Medical Sciences (IMS) and SUM Hospital

Bhubaneswar, Odisha, 751003, India

Location

Related Publications (20)

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  PMID: 15572881 RESULT

• Rubin G, Dale A. Chronic constipation in children. BMJ. 2006 Nov 18;333(7577):1051-5. doi: 10.1136/bmj.39007.760174.47. No abstract available.

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• van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006 Oct;101(10):2401-9. doi: 10.1111/j.1572-0241.2006.00771.x.

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• Tran DL, Sintusek P. Functional constipation in children: What physicians should know. World J Gastroenterol. 2023 Feb 28;29(8):1261-1288. doi: 10.3748/wjg.v29.i8.1261.

  PMID: 36925458 RESULT

• Rasquin A, Di Lorenzo C, Forbes D, Guiraldes E, Hyams JS, Staiano A, Walker LS. Childhood functional gastrointestinal disorders: child/adolescent. Gastroenterology. 2006 Apr;130(5):1527-37. doi: 10.1053/j.gastro.2005.08.063.

  PMID: 16678566 RESULT

• Shatnawi MS, Alrwalah MM, Ghanma AM, Alqura'an ML, Zreiqat EN, Alzu'bi MM. Lactulose versus polyethylene glycol for disimpaction therapy in constipated children, a randomized controlled study. Sudan J Paediatr. 2019;19(1):31-36. doi: 10.24911/SJP.106-1546805996.

  PMID: 31384086 RESULT

• Tabbers MM, DiLorenzo C, Berger MY, Faure C, Langendam MW, Nurko S, Staiano A, Vandenplas Y, Benninga MA; European Society for Pediatric Gastroenterology, Hepatology, and Nutrition; North American Society for Pediatric Gastroenterology. Evaluation and treatment of functional constipation in infants and children: evidence-based recommendations from ESPGHAN and NASPGHAN. J Pediatr Gastroenterol Nutr. 2014 Feb;58(2):258-74. doi: 10.1097/MPG.0000000000000266.

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  PMID: 23591910 RESULT

• Treepongkaruna S, Simakachorn N, Pienvichit P, Varavithya W, Tongpenyai Y, Garnier P, Mathiex-Fortunet H. A randomised, double-blind study of polyethylene glycol 4000 and lactulose in the treatment of constipation in children. BMC Pediatr. 2014 Jun 19;14:153. doi: 10.1186/1471-2431-14-153.

  PMID: 24943105 RESULT

• Candy DC, Edwards D, Geraint M. Treatment of faecal impaction with polyethelene glycol plus electrolytes (PGE + E) followed by a double-blind comparison of PEG + E versus lactulose as maintenance therapy. J Pediatr Gastroenterol Nutr. 2006 Jul;43(1):65-70. doi: 10.1097/01.mpg.0000228097.58960.e6.

  PMID: 16819379 RESULT

• Youssef NN, Peters JM, Henderson W, Shultz-Peters S, Lockhart DK, Di Lorenzo C. Dose response of PEG 3350 for the treatment of childhood fecal impaction. J Pediatr. 2002 Sep;141(3):410-4. doi: 10.1067/mpd.2002.126603.

  PMID: 12219064 RESULT

• Bekkali NL, van den Berg MM, Dijkgraaf MG, van Wijk MP, Bongers ME, Liem O, Benninga MA. Rectal fecal impaction treatment in childhood constipation: enemas versus high doses oral PEG. Pediatrics. 2009 Dec;124(6):e1108-15. doi: 10.1542/peds.2009-0022.

  PMID: 19948614 RESULT

• Miller MK, Dowd MD, Friesen CA, Walsh-Kelly CM. A randomized trial of enema versus polyethylene glycol 3350 for fecal disimpaction in children presenting to an emergency department. Pediatr Emerg Care. 2012 Feb;28(2):115-9. doi: 10.1097/PEC.0b013e3182442c0a.

  PMID: 22270500 RESULT

• Seinela L, Sairanen U, Laine T, Kurl S, Pettersson T, Happonen P. Comparison of polyethylene glycol with and without electrolytes in the treatment of constipation in elderly institutionalized patients: a randomized, double-blind, parallel-group study. Drugs Aging. 2009;26(8):703-13. doi: 10.2165/11316470-000000000-00000.

  PMID: 19685935 RESULT

• Chaussade S, Minic M. Comparison of efficacy and safety of two doses of two different polyethylene glycol-based laxatives in the treatment of constipation. Aliment Pharmacol Ther. 2003 Jan;17(1):165-72. doi: 10.1046/j.1365-2036.2003.01390.x.

  PMID: 12492746 RESULT

• Szojda MM, Mulder CJ, Felt-Bersma RJ. Differences in taste between two polyethylene glycol preparations. J Gastrointestin Liver Dis. 2007 Dec;16(4):379-81.

  PMID: 18193118 RESULT

• Katelaris P, Naganathan V, Liu K, Krassas G, Gullotta J. Comparison of the effectiveness of polyethylene glycol with and without electrolytes in constipation: a systematic review and network meta-analysis. BMC Gastroenterol. 2016 Mar 31;16:42. doi: 10.1186/s12876-016-0457-9.

  PMID: 27029340 RESULT

• Bekkali NLH, Hoekman DR, Liem O, Bongers MEJ, van Wijk MP, Zegers B, Pelleboer RA, Verwijs W, Koot BGP, Voropaiev M, Benninga MA. Polyethylene Glycol 3350 With Electrolytes Versus Polyethylene Glycol 4000 for Constipation: A Randomized, Controlled Trial. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):10-15. doi: 10.1097/MPG.0000000000001726.

  PMID: 28906317 RESULT

• Savino F, Viola S, Erasmo M, Di Nardo G, Oliva S, Cucchiara S. Efficacy and tolerability of peg-only laxative on faecal impaction and chronic constipation in children. A controlled double blind randomized study vs a standard peg-electrolyte laxative. BMC Pediatr. 2012 Nov 15;12:178. doi: 10.1186/1471-2431-12-178.

  PMID: 23152962 RESULT

• Boles EE, Gaines CL, Tillman EM. Comparison of Polyethylene Glycol-Electrolyte Solution vs Polyethylene Glycol-3350 for the Treatment of Fecal Impaction in Pediatric Patients. J Pediatr Pharmacol Ther. 2015 May-Jun;20(3):210-6. doi: 10.5863/1551-6776-20.3.210.

  PMID: 26170773 RESULT

MeSH Terms

Conditions

Fecal Impaction

Interventions

Electrolytes

Condition Hierarchy (Ancestors)

Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Kalpana Panda, MD, DM

  Associate Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kalpana Panda, MD, DM

CONTACT

91-9717133189; drkalpanapanda@gmail.com

J Bikrant Kumar Prusty, MD

CONTACT

91-9090205041; princjammy142@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL

Study Record Dates

• First Submitted: March 30, 2024
• First Posted: April 5, 2024
• Study Start: April 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: September 15, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)