Constipation - Functional
Conditions
Keywords
constipation
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.
Interventions
DIETARY_SUPPLEMENTManna
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.
Sponsors
Iuppa Industriale S.r.l.
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome of therapeutic effect | At 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module | Every week for 8 weeks | The questionnaire PedsQL Gastrointestinal Symptoms Module has a scale that typically ranges from 0 to 100: higher scores indicate a better outcome, representing fewer symptoms and higher health-related quality of life. |
| Number of Bowel Movements | Daily for 8 weeks | Number of bowel movements, recorded daily |
| Outcome of safety | At 8 weeks | The safety outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoints: * Absence of gastrointestinal-related adverse events during the study period. * Other adverse events (mild or severe) reported by parents during the study period, including pain, infections, or any other events related to the intervention |
| Involuntary Fecal Loss | Daily for 8 weeks | Daily dairy of involuntary fecal loss with Yes/No indicator. |
| Additional Symptoms | Daily for 8 weeks | Daily dairy of additional symptoms such as bloating (sensation of a swollen belly), abdominal pain, discomfort (general abdominal disturbance), and straining during defecation |
| Stool Consistency | Daily for 8 weeks | Daily dairy of stool consistency, assessed using the Bristol Stool Scale, which categorizes stool types from 1 very costipated to 7 Inflammation and Diarrhea. |
Countries
Italy
Outcome results
None listed