Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation

Constipation - Functional Clinical Trial

— MANNAPED  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06404853
• Other study ID #: ASO.Ped.20.07
• Status: Completed
• Phase: N/A
• Start date: March 16, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 31, 2023
• Est. primary completion date: March 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation - Functional

Intervention

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.

Locations

Country	Name	City	State
Italy	SC Pediatria	Alessandria	Piedmont

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria	Iuppa Industriale S.r.l.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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.	At 8 weeks
Secondary	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	At 8 weeks
Secondary	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
Secondary	Number of Bowel Movements	Number of bowel movements, recorded daily	Daily for 8 weeks
Secondary	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
Secondary	Involuntary Fecal Loss	Daily dairy of involuntary fecal loss with Yes/No indicator.	Daily for 8 weeks
Secondary	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