An interventional study of Manna in Constipation - Functional, sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria. Completed at 1 site in Italy. Open to participants aged 6 Months to 16 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria · Not applicable, Interventional, and Treatment
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.
1,041 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's enrollment of 110 is above the median of 78 across 867 interventional studies indexed under Constipation.
Browse Constipation studies →Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria is the lead sponsor of 37 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Administration of supplement dietary manna
Dietary Supplement: Manna
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 8 weeks
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: * 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
Time frame: 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.
Time frame: Every week for 8 weeks
Number of Bowel Movements
Number of bowel movements, recorded daily
Time frame: 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".
Time frame: Daily for 8 weeks
Involuntary Fecal Loss
Daily dairy of involuntary fecal loss with Yes/No indicator.
Time frame: 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
Time frame: Daily for 8 weeks
Ran from Mar 2021 to primary completion in Mar 2022, 12 months.
Of 229 non-industry interventional studies with no phase under Constipation, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's 12 months is below that.
Counting every sponsor, half of 296 studies reached it within 14 months; a quarter within 7 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria