Comparison of Efficacy & Tolerability Of PEG 4000 Versus PEG 3350+ Electrolytes for Pediatric Fecal Disimpaction
NCT ID: NCT06349031
Last Updated: 2024-04-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE4
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-15
Study Completion Date
2024-09-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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 arm
2. Cumulative dose of PEG required for fecal disimpaction in each arm
3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm
4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm
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 arm
2. Cumulative dose of PEG required for fecal disimpaction in each arm
3. Proportion of subjects (\> 5 years age) reporting palatability issues in each arm
4. Proportion of subjects discontinuing the treatment due to palatability issues in each arm
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Efficacy and Palatability of Developed Polyethylene Glycol-based Formula for Children With Functional Constipation
NCT06357897
Functional Constipation
NOT_YET_RECRUITING
NA
Maintenance Treatment for Children With Constipation
NCT01566409
Constipation
COMPLETED
NA
Dried Plums (Prunes) vs. Polyethylene Glycol 4000 for Treatment of Functional Constipation in Children
NCT03639142
Functional Constipation
UNKNOWN
PHASE3
Efficacy and Tolerability of PEG-only Laxative for Fecal Impaction and Chronic Constipation in Children
NCT01592734
Constipation
Faecal Impaction
COMPLETED
PHASE4
Polyethylene Glycol for Childhood Constipation
NCT01875744
Constipation
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide. In approximately 90-95% of children, it is of functional origin i.e., without an identifiable organic pathology. It accounts for 3% of pediatric outpatient visits and 25% of referrals to a pediatric gastroenterologist. Prevalence rates ranging from 0.7% to 29.6% with a median of 8.9% have been described in the older literature, with a higher prevalence in Asian population. However, in a recent study, using the Rome IV criteria, the pooled global prevalence of pediatric functional constipation is found to be 14.4% (95%CI: 11.2-17.6). Severe longstanding constipation is distressing for the entire family and poses a substantial psychological, social, and educational strain on the child's development.
Thirty to seventy-five percent of children with functional constipation also have fecal impaction. It typically begins after several bouts of painful bowel movements, which triggers a vicious cycle of fear-induced stool-withholding behavior leading to more stool retention. Consequently, a significant amount of feces accumulates in the rectum forming a big fecal mass or fecaloma, causing a variety of complaints, including gastrointestinal discomfort, excessive flatulence, nausea or vomiting, poor appetite, mood swings \& irritability. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) \& the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) position paper on pediatric constipation defines fecal impaction as any one of the following: i) palpation of a hard mass in the lower abdomen on physical examination, ii) a dilated rectum filled with a large amount of stool on rectal examination, iii) abdominal radiography showing excessive stool in the distal colon.
The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements. ESPGHAN \& NASPGHAN guidelines emphasize that maintenance therapy remains ineffective until disimpaction has been achieved. If initial disimpaction is skipped, oral laxative therapy may paradoxically worsen fecal incontinence/encopresis attributable to overflow diarrhea.
Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents for both disimpaction as well as maintenance therapy in childhood functional constipation. PEG, a biologically inert polymer of the formula H(OCH2CH2)nOH in which n is 68-84. These are non-absorbable polymers, that create an osmotic gradient in the intestinal lumen leading to fluid retention which in turn softens and loosens the stool. Hence, they act as osmotic laxatives. As it does not carry any electrical charge, it does not influence the movement of any other solutes. The commonly used formulations are PEG 3350 with a molecular weight between 3200 and 3700 g/mol and PEG 4000 with an approximate molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. However, there is scanty literature available comparing other aspects of various PEG formulations, such as tolerability, palatability, \& convenience of administration, which may affect treatment adherence and thus the ultimate treatment outcome. PEG + Electrolyte (E) is more widely used than PEG for the management of constipation. This might be because of the perception that PEG + E is safer in terms of preventing electrolyte imbalance.
However, several head-to-head trials using different PEG formulations in adult constipation patients, showed comparable efficacy and safety. Because of the inclusion of electrolytes, PEG+E tastes saltier than PEG. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance and treatment failure . Two studies from the adult population have demonstrated better acceptance of PEG in comparison to PEG+E . In fact, the latest meta-analysis concluded that the addition of electrolytes to PEG does not provide any clinical benefits over PEG alone.
In a recent double-blind RCT, PEG 4000 is found to be equally efficacious and safe as PEG 3350 + E as a long-term maintenance therapy in children with functional constipation . However, they have not described the tolerability or acceptability data of the cohort. There is only a single pediatric study that showed, PEG 4000 is equally effective and had a higher patient acceptance rate owing to significantly lesser nausea, vomiting episodes, and better palatability compared to PEG 3350. However, both these studies are majorly focused on the comparison between PEG 3350 + E versus PEG 4000 as a long-term maintenance therapy in pediatric functional constipation. There is only a single study that compared PEG 3350 versus PEG 3350 only laxative for fecal disimpaction. Both of them were found to almost equally effective in resolution of fecal impaction, however PEG 3350 + E group had significantly higher side effects as compared to PEG 3350 only laxative.
To date, no pediatric trials have compared PEG versus PEG+E on a head-to-head basis for the treatment of the initial but most important \& crucial step of pediatric function constipation management i.e. Fecal disimpaction. Since fecal disimpaction requires administration of a significantly larger volume of PEG administration, palatability becomes a major factor determining the success of disimpaction. On the other hand, there is also of higher possibility of side effects like electrolyte \& acid base imbalances because of higher purge rate during disimpaction. Comparison of both these parameters namely tolerability/palatability and safety/side effects profile of PEG versus PEG + E during fecal disimpaction in pediatric population has not been studied previously.
Therefore, the present study has been planned with an aim to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ electrolytes for fecal disimpaction in paediatric functional constipation.
Thirty to seventy-five percent of children with functional constipation also have fecal impaction. It typically begins after several bouts of painful bowel movements, which triggers a vicious cycle of fear-induced stool-withholding behavior leading to more stool retention. Consequently, a significant amount of feces accumulates in the rectum forming a big fecal mass or fecaloma, causing a variety of complaints, including gastrointestinal discomfort, excessive flatulence, nausea or vomiting, poor appetite, mood swings \& irritability. European Society for Pediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) \& the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (NASPGHAN) position paper on pediatric constipation defines fecal impaction as any one of the following: i) palpation of a hard mass in the lower abdomen on physical examination, ii) a dilated rectum filled with a large amount of stool on rectal examination, iii) abdominal radiography showing excessive stool in the distal colon.
The treatment strategy for functional constipation includes fecal disimpaction and maintenance therapy to ensure regular bowel movements. ESPGHAN \& NASPGHAN guidelines emphasize that maintenance therapy remains ineffective until disimpaction has been achieved. If initial disimpaction is skipped, oral laxative therapy may paradoxically worsen fecal incontinence/encopresis attributable to overflow diarrhea.
Polyethylene glycol (PEG) based laxatives have been recommended as the first-line therapeutic agents for both disimpaction as well as maintenance therapy in childhood functional constipation. PEG, a biologically inert polymer of the formula H(OCH2CH2)nOH in which n is 68-84. These are non-absorbable polymers, that create an osmotic gradient in the intestinal lumen leading to fluid retention which in turn softens and loosens the stool. Hence, they act as osmotic laxatives. As it does not carry any electrical charge, it does not influence the movement of any other solutes. The commonly used formulations are PEG 3350 with a molecular weight between 3200 and 3700 g/mol and PEG 4000 with an approximate molecular weight of 4000 g/mol. Both are shown to be effective in pediatric constipation management in placebo-controlled trials. However, there is scanty literature available comparing other aspects of various PEG formulations, such as tolerability, palatability, \& convenience of administration, which may affect treatment adherence and thus the ultimate treatment outcome. PEG + Electrolyte (E) is more widely used than PEG for the management of constipation. This might be because of the perception that PEG + E is safer in terms of preventing electrolyte imbalance.
However, several head-to-head trials using different PEG formulations in adult constipation patients, showed comparable efficacy and safety. Because of the inclusion of electrolytes, PEG+E tastes saltier than PEG. Many patients struggle to tolerate the unpleasant taste resulting in the high incidence of non-compliance and treatment failure . Two studies from the adult population have demonstrated better acceptance of PEG in comparison to PEG+E . In fact, the latest meta-analysis concluded that the addition of electrolytes to PEG does not provide any clinical benefits over PEG alone.
In a recent double-blind RCT, PEG 4000 is found to be equally efficacious and safe as PEG 3350 + E as a long-term maintenance therapy in children with functional constipation . However, they have not described the tolerability or acceptability data of the cohort. There is only a single pediatric study that showed, PEG 4000 is equally effective and had a higher patient acceptance rate owing to significantly lesser nausea, vomiting episodes, and better palatability compared to PEG 3350. However, both these studies are majorly focused on the comparison between PEG 3350 + E versus PEG 4000 as a long-term maintenance therapy in pediatric functional constipation. There is only a single study that compared PEG 3350 versus PEG 3350 only laxative for fecal disimpaction. Both of them were found to almost equally effective in resolution of fecal impaction, however PEG 3350 + E group had significantly higher side effects as compared to PEG 3350 only laxative.
To date, no pediatric trials have compared PEG versus PEG+E on a head-to-head basis for the treatment of the initial but most important \& crucial step of pediatric function constipation management i.e. Fecal disimpaction. Since fecal disimpaction requires administration of a significantly larger volume of PEG administration, palatability becomes a major factor determining the success of disimpaction. On the other hand, there is also of higher possibility of side effects like electrolyte \& acid base imbalances because of higher purge rate during disimpaction. Comparison of both these parameters namely tolerability/palatability and safety/side effects profile of PEG versus PEG + E during fecal disimpaction in pediatric population has not been studied previously.
Therefore, the present study has been planned with an aim to evaluate the efficacy \& tolerability of PEG 4000 versus PEG 3350+ electrolytes for fecal disimpaction in paediatric functional constipation.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Functional Constipation
Fecal Impaction
Constipation - Functional
Constipation Chronic Idiopathic
Pediatric Functional Constipation
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
DOUBLE BLIND RANDOMIZED CONTROLLED TRIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
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.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Polyethylene glycol (PEG) 3350 +Electrolytes ARM
\[PEG 33500+Electrolyte\] 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
Group Type
ACTIVE_COMPARATOR
Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants
Intervention Type
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) 4000 ARM
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
Group Type
EXPERIMENTAL
Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants
Intervention Type
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Administration of Polyethylene Glycol (PEG) 4000 as per treatment allocation to participants
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
Intervention Type
DRUG
Administration of Polyethylene Glycol (PEG) 3350 + Electrolyte as per treatment allocation to participants
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
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
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
Minimum Eligible Age
1 Year
Maximum Eligible Age
16 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Institute of Medical Sciences and SUM Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Kalpana Panda
Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kalpana Panda, MD, DM
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute of Medical Sciences (IMS) and SUM Hospital
Bhubaneswar, Odisha, India
Site Status
Countries
Review the countries where the study has at least one active or historical site.
India
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Benninga MA, Voskuijl WP, Taminiau JA. Childhood constipation: is there new light in the tunnel? J Pediatr Gastroenterol Nutr. 2004 Nov;39(5):448-64. doi: 10.1097/00005176-200411000-00002. No abstract available.
Reference Type
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.
Reference Type
RESULT
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.
Reference Type
RESULT
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Alper A, Pashankar DS. Polyethylene glycol: a game-changer laxative for children. J Pediatr Gastroenterol Nutr. 2013 Aug;57(2):134-40. doi: 10.1097/MPG.0b013e318296404a.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IEC/IMS.SH/SOA/2024/683
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
PolyethyleneGlycol3350 Laxative vs Placebo in Constipated Children
NCT00153114
COMPLETED
PHASE4
Comparison Trial of Enema vs. PEG 3350 for Constipation
NCT00467350
TERMINATED
NA
To Determine the Effect of Forlax® Treatment in Children With Chronic Constipation Who May Also Suffer From Soiling/ Faecal Incontinence.
NCT00255372
COMPLETED
PHASE3
Efficacy and Safety of Polyethylene Glycol 3350 (PEG 3350) for Relief of Constipation (MK-8114-005)
NCT02292459
WITHDRAWN
PHASE3
Prucalopride in Pediatric Subjects With Functional Constipation
NCT01330381
COMPLETED
PHASE3
Dose-Finding Trial of Polyethylene Glycol 3350 Laxative Plus Electrolytes for the Treatment of Constipation (Protocol P07515)
NCT01212445
COMPLETED
PHASE2
RCE With FMT in the Treatment of Childhood Constipation
NCT05035784
COMPLETED
NA
Comparison of PolyethyleneGlycol and Placebo for Relief of Constipation From Constipating Medications
NCT00153127
COMPLETED
PHASE4
The Efficacy Side Effects and the Tolerance of Polyethylene Glycol 3350 as a Bowel Prep in Children
NCT01164410
COMPLETED
Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months
NCT02751411
COMPLETED
PHASE4
A Trial to Evaluate the Efficacy and Safety of PMF104 Compared to a Conventional PEG-electrolyte Solution in Children
NCT03106922
UNKNOWN
PHASE3
A Pilot Study of a New MiraLax® Dose Formulation For Use in Constipated Children
NCT00319670
COMPLETED
PHASE4
Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children
NCT01518790
COMPLETED
NA
A Study of Prucalopride For Functional Constipation in Children and Teenagers
NCT04759833
TERMINATED
PHASE3
Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.
NCT03177434
UNKNOWN
PHASE4
Different Bowel Preparations for Colonoscopy In Children
NCT01711437
UNKNOWN
PHASE4
Evaluation of One-day Polyethylene Glycol Powder Solution for Colonoscopy in Children
NCT01626040
COMPLETED
Polyethyleneglycol3350 vs Tegaserod in Treatment of Patients With Chronic Constipation
NCT00153140
COMPLETED
PHASE4
Safety and Tolerability of Oral Polyethylene Glycol (PEG 3350) Solution in Participants With Constipation (MK-8114-003)
NCT01885104
COMPLETED
PHASE2
Comparison of PEG Solutions With and Without Electrolytes in the Treatment of Constipation
NCT00603681
COMPLETED
PHASE4
Randomized, Double-Blinded, Placebo-Controlled Trial of Laxatives for Children With Urge Syndrome
NCT00765557
COMPLETED
EARLY_PHASE1
Movicol in Childhood Constipation (ProMotion Study)
NCT00404040
COMPLETED
PHASE2
Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
NCT03957668
UNKNOWN
PHASE3
PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy
NCT01531140
COMPLETED
PHASE4