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

NCT ID: NCT06404853

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2023-12-31

Brief 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.

Detailed 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.

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.

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.

Conditions

Constipation - Functional

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Supplement dietary manna

Administration of supplement dietary manna

Group Type: OTHER

Manna

Intervention Type: DIETARY_SUPPLEMENT

Administration is by the oral route according to weight at a dosage of 1 g/kg/day, dissolved in a glass of water, up to a maximum of 30 g. Administration should be repeated every 24 h for 8 weeks, accompanied by plenty of hydration.

In case an effective dosage is achieved (evacuation within 72 h) it will be maintained until the end of the study. If evacuation has not occurred after 72 h, evacuative enema and increased dosage to 1.5 g/kg/day will be indicated. If further evacuative enema is needed, product administration will be discontinued and classical polyethylene glycol therapy will be started as per guidelines.

Interventions

Manna

Administration is by the oral route according to weight at a dosage of 1 g/kg/day, dissolved in a glass of water, up to a maximum of 30 g. Administration should be repeated every 24 h for 8 weeks, accompanied by plenty of hydration.

In case an effective dosage is achieved (evacuation within 72 h) it will be maintained until the end of the study. If evacuation has not occurred after 72 h, evacuative enema and increased dosage to 1.5 g/kg/day will be indicated. If further evacuative enema is needed, product administration will be discontinued and classical polyethylene glycol therapy will be started as per guidelines.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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 Criteria

• Presence of organic causes of bowel disorders (Hirschsprung's disease, spinal abnormalities or anorectal pathology; history of gastro-intestinal surgery), celiac disease
• 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 dietary supplement mannite

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iuppa Industriale S.r.l.

UNKNOWN

Sponsor Role: collaborator

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Felici

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

Locations

SC Pediatria

Alessandria, Piedmont, Italy

Countries

Italy

Other Identifiers

ASO.Ped.20.07

Identifier Type: -

Identifier Source: org_study_id