Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation

Phase

N/A

Condition

Constipation

Treatment

Manna

Clinical Study ID

NCT06404853

ASO.Ped.20.07

Ages 6-16
All Genders

Study Summary

Functional constipation is a widely prevalent pediatric issue, with a prevalence in some studies as high as 32.2%.

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 1,4-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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Diagnosis of functional constipation defined according to Rome IV criteria.
Age between 6 months and 16 years.
Informed consent signed by parent/legal guardian

Exclusion

Exclusion Criteria:

Presence of organic causes of bowel disorders (Hirschsprung's disease, spinalabnormalities or anorectal pathology; history of gastro-intestinal surgery), celiacdisease
Mental retardation
Irritable bowel syndrome
Taking medications that affect gastro-intestinal motility in the previous 4 weeks
Clinical suggestive of metabolic disease (e.g., hypothyroidism)
Known hypersensitivity to manna, mannitol, or other ingredient in the dietarysupplement mannite

Study Design

Manna

March 16, 2021

December 31, 2023

Study Description

Functional constipation is a widely prevalent pediatric issue, with a prevalence in some studies as high as 32.2%. 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.