Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404853
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2024-02-29
Brief Title:
Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation
Sponsor:
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
Organization:
Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo di Alessandria
Study Overview
Official Title:
Multicenter Open-label Noncomparative Study to Evaluate the Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation
Status:
COMPLETED
Status Verified Date:
2024-05
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:
MANNAPED
Brief Summary:
Functional constipation is a widely prevalent pediatric issue with a prevalence in some studies as high as 322
Treatment consists of a combination of behavioral and pharmacological interventions mainly administration of polyethylene glycol laxatives or the use of enemas
Glucomannan GNN is a polysaccharide of 14-D-glucose and D-mannose found in the soluble fiber of some plants While studies available in the literature to date agree that mannite is a dietary supplement with safe use the usefulness of this compound remains controversial
Treatment consists of a combination of behavioral and pharmacological interventions mainly administration of polyethylene glycol laxatives or the use of enemas
Glucomannan GNN is a polysaccharide of 14-D-glucose and D-mannose found in the soluble fiber of some plants While studies available in the literature to date agree that mannite is a dietary supplement with safe use the usefulness of this compound remains controversial
Detailed Description:
Functional constipation is a widely prevalent pediatric issue with a prevalence in some studies as high as 322 Characterized by annoying and embarrassing symptoms such as reduced number of evacuations increased stool consistency fecal incontinence and abdominal pain functional constipation has a negative impact on the quality of life of affected children and their families It is a frequent reason for referral to the general pediatrician and pediatric gastroenterologist and significantly impacts health care spending The guidelines publicized by the European Society for Pediatric Gastroenterology Hepatology and Nutrition ESPGHAN and the North American Society for Pediatric Gastroenterology Hepatology and Nutrition NASPGHAN on functional constipation in children provide the most up-to-date evidence-based recommendations for the evaluation treatment and follow-up of children with this condition Key indications include a diagnosis based on history and physical examination and a definition of functional constipation based on the criteria of Rome
Treatment consists of a combination of behavioral and pharmacological interventions mainly administration of polyethylene glycol laxatives or the use of enemas
Glucomannan GNN is a polysaccharide of 14-D-glucose and D-mannose found in the soluble fiber of some plants While studies available in the literature to date agree that mannite is a dietary supplement with safe use the usefulness of this compound remains controversial
The study aims to evaluate the effect of Mannite supplement composed of 90 Mannite from Fructose and 10 Manna from Ash as a unique therapy in the treatment of functional constipation
Treatment consists of a combination of behavioral and pharmacological interventions mainly administration of polyethylene glycol laxatives or the use of enemas
Glucomannan GNN is a polysaccharide of 14-D-glucose and D-mannose found in the soluble fiber of some plants While studies available in the literature to date agree that mannite is a dietary supplement with safe use the usefulness of this compound remains controversial
The study aims to evaluate the effect of Mannite supplement composed of 90 Mannite from Fructose and 10 Manna from Ash as a unique therapy in the treatment of 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?:
None
Is an FDA AA801 Violation?:
None