Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation
- Conditions
- Constipation - Functional
- Interventions
- Dietary Supplement: Manna
- Registration Number
- NCT06404853
- Lead Sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- Diagnosis of functional constipation defined according to Rome IV criteria.
- Age between 6 months and 16 years.
- Informed consent signed by parent/legal guardian
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supplement dietary manna Manna Administration of supplement dietary manna
- Primary Outcome Measures
Name Time Method 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:
· Number of flatulence episodes within a week.
- Secondary Outcome Measures
Name Time Method 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 interventionAdditional 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
Involuntary Fecal Loss Daily for 8 weeks Daily dairy of involuntary fecal loss with Yes/No indicator.
Number of Bowel Movements Daily for 8 weeks Number of bowel movements, recorded daily
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".
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.
Trial Locations
- Locations (1)
SC Pediatria
🇮🇹Alessandria, Piedmont, Italy