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| Name | Class |
|---|---|
| Iuppa Industriale S.r.l. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supplement dietary manna | Other | Administration of supplement dietary manna |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Outcome of safety | The safety outcome assessment of the mannitol-based dietary supplement in the treatment of pediatric constipation will be evaluated through the following endpoints:
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enrico Felici | Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SC Pediatria | Alessandria | Piedmont | 15121 | Italy |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C022901 | (1-6)-alpha-glucomannan |
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| At 8 weeks |
| At 8 weeks |
| Questionnaire Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module | 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. | Every week for 8 weeks |
| Number of Bowel Movements | Number of bowel movements, recorded daily | Daily for 8 weeks |
| Stool Consistency | Daily dairy of stool consistency, assessed using the Bristol Stool Scale, which categorizes stool types from 1 "very costipated" to 7 "Inflammation and Diarrhea". | Daily for 8 weeks |
| Involuntary Fecal Loss | Daily dairy of involuntary fecal loss with Yes/No indicator. | Daily for 8 weeks |
| Additional Symptoms | Daily dairy of additional symptoms such as bloating (sensation of a swollen belly), abdominal pain, discomfort (general abdominal disturbance), and straining during defecation | Daily for 8 weeks |