Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349031
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-03-30
Brief Title:
Comparison of Efficacy Tolerability Of PEG 4000 Versus PEG 3350 Electrolytes for Pediatric Fecal Disimpaction
Sponsor:
Institute of Medical Sciences and SUM Hospital
Organization:
Institute of Medical Sciences and SUM Hospital
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 gmol and PEG 4000 with molecular weight of 4000 gmol 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 3350E 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 3350E at a ratio of 11 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 15 gmkgday 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 gmol and PEG 4000 with molecular weight of 4000 gmol 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 3350E 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 3350E at a ratio of 11 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 15 gmkgday 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
Detailed Description:
Childhood constipation is a common but serious gastrointestinal disorder prevalent worldwide In approximately 90-95 of children it is of functional origin ie 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 07 to 296 with a median of 89 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 144 95CI 112-176 Severe longstanding constipation is distressing for the entire family and poses a substantial psychological social and educational strain on the childs 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 incontinenceencopresis 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 HOCH2CH2nOH 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 gmol and PEG 4000 with an approximate molecular weight of 4000 gmol 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 PEGE 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 PEGE 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 PEGE on a head-to-head basis for the treatment of the initial but most important crucial step of pediatric function constipation management ie 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 tolerabilitypalatability and safetyside 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 incontinenceencopresis 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 HOCH2CH2nOH 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 gmol and PEG 4000 with an approximate molecular weight of 4000 gmol 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 PEGE 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 PEGE 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 PEGE on a head-to-head basis for the treatment of the initial but most important crucial step of pediatric function constipation management ie 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 tolerabilitypalatability and safetyside 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None