Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional… (NCT06404853) | Clinical Trial Compass
CompletedNot Applicable
Effect and Safety of the Dietary Supplement Mannite in Pediatric Patients With Chronic Functional Constipation
Italy110 participantsStarted 2021-03-16
Plain-language 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.
Who can participate
Age range
6 Months – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Outcome of therapeutic effect
Timeframe: At 8 weeks
2
Outcome of therapeutic effect
Timeframe: At 8 weeks
3
Outcome of therapeutic effect
Timeframe: At 8 weeks
4
Outcome of therapeutic effect
Timeframe: At 8 weeks
5
Outcome of therapeutic effect
Timeframe: At 8 weeks
6
Outcome of therapeutic effect
Timeframe: At 8 weeks
Trial details
NCT IDNCT06404853
SponsorAzienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria