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

NCT06404853 | Completed

• 1 other identifier: ASO.Ped.20.07
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Constipation - Functional

Keywords

constipation

Outcome Measures

Primary Outcomes (6)

• Outcome of therapeutic effect

  The therapeutic outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoint: · Spontaneous bowel movements more than twice per week.

  At 8 weeks

• Outcome of therapeutic effect

  The therapeutic outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoint: · Absence of soiling episodes.

  At 8 weeks

• Outcome of therapeutic effect

  The therapeutic outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoint: · Number of painful evacuations or evacuations with hard stools per week.

  At 8 weeks

• Outcome of therapeutic effect

  The therapeutic outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoint: · Number of episodes of abdominal pain per week.

  At 8 weeks

• Outcome of therapeutic effect

  The therapeutic outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoint: · Need for evacuative enema treatment due to lack of evacuation for three consecutive days.

  At 8 weeks

• Outcome of therapeutic effect

  The therapeutic outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoint: · Number of flatulence episodes within a week.

  At 8 weeks

Secondary Outcomes (6)

• Outcome of safety

  At 8 weeks

• Questionnaire Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module

  Every week for 8 weeks

• Number of Bowel Movements

  Daily for 8 weeks

• Stool Consistency

  Daily for 8 weeks

• Involuntary Fecal Loss

  Daily for 8 weeks

Study Arms (1)

Supplement dietary manna

OTHER

Administration of supplement dietary manna

Dietary Supplement: Manna

Interventions

Manna 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.

Supplement dietary manna

Eligibility Criteria

• Age: 6 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria: lead
• Iuppa Industriale S.r.l.: collaborator

Study Sites (1)

SC Pediatria

Alessandria, Piedmont, 15121, Italy

Location

MeSH Terms

Conditions

Constipation

Interventions

(1-6)-alpha-glucomannan

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Felici

  Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: May 8, 2024
• Study Start: March 16, 2021
• Primary Completion: March 16, 2022
• Study Completion: December 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

IT (1)