Clinical trial NCT06404853: Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Keywords: constipation
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
Collaborators: name: Iuppa Industriale S.r.l.
First posted: 2024-05-08
Enrollment: 110
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Outcome of therapeutic effect
timeFrame: At 8 weeks
measure: Outcome of therapeutic effect
timeFrame: At 8 weeks
measure: Outcome of therapeutic effect
timeFrame: At 8 weeks
measure: Outcome of therapeutic effect
timeFrame: At 8 weeks
measure: Outcome of therapeutic effect
timeFrame: At 8 weeks
measure: Outcome of therapeutic effect
timeFrame: At 8 weeks
Secondary outcomes:
measure: Outcome of safety
timeFrame: At 8 weeks
measure: Questionnaire Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module
timeFrame: Every week for 8 weeks
measure: Number of Bowel Movements
timeFrame: Daily for 8 weeks
measure: Stool Consistency
timeFrame: Daily for 8 weeks
measure: Involuntary Fecal Loss
timeFrame: Daily for 8 weeks
measure: Additional Symptoms
timeFrame: Daily for 8 weeks
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: SC Pediatria
state: Piedmont
Study officials:
affiliation: Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo
name: Enrico Felici
role: PRINCIPAL_INVESTIGATOR
References: