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Completed

NCT Number: NCT06404853

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

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.

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Key information

Conditions

Constipation - Functional Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

6 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SC Pediatria

Alessandria, Piedmont, 15121, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Outcome of therapeutic effect

    Time frame: 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.

  2. Outcome of therapeutic effect

    Time frame: 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:

    · Absence of soiling episodes.

  3. Outcome of therapeutic effect

    Time frame: 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 painful evacuations or evacuations with hard stools per week.

  4. Outcome of therapeutic effect

    Time frame: 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 episodes of abdominal pain per week.

  5. Outcome of therapeutic effect

    Time frame: 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:

    · Need for evacuative enema treatment due to lack of evacuation for three consecutive days.

  6. Outcome of therapeutic effect

    Time frame: 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 outcomes

  1. Outcome of safety

    Time frame: 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

  2. Questionnaire Pediatric Quality of Life Inventory Gastrointestinal Symptoms Module

    Time frame: 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.

  3. Number of Bowel Movements

    Time frame: Daily for 8 weeks

    Number of bowel movements, recorded daily

  4. Stool Consistency

    Time frame: 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".

  5. Involuntary Fecal Loss

    Time frame: Daily for 8 weeks

    Daily dairy of involuntary fecal loss with Yes/No indicator.

  6. Additional Symptoms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria

Other

Collaborators

  • Iuppa Industriale S.r.l.

Registry information

Official study title

Multicenter Open-label Noncomparative Study to Evaluate the Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation

Acronym: MANNAPED

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 8, 2024
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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