NCT05192317

Administration of a Natural Molecular Complex in Functional Chronic Constipation

A Randomized, Parallel Group, Placebo-controlled, Double Blinded Clinical Trial to Evaluate the Efficacy and Safety of the Substance-based Medical Device (Sollievo Fisiolax) in the Treatment of Chronic Constipation.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: Aboca Spa Societa' Agricola · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double-blinded placebo controlled trial to evaluate the efficacy and safety of the substance-based medical device (Sollievo Fisiolax) in the treatment of Chronic Constipation. Treatment period for each patient is 28 days.

Detailed description

According to the criteria of Rome IV, 86 patients diagnosed from chronic constipation will be enrolled by up to ten centers. The study includes 2 visits at the site center and 1 by phone call. V-1 (eligibility assessment / screening visit): * Collection of written informed consent * Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate) * Diagnosis according to Rome IV criteria of chronic functional constipation * Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis. * Performing a colonoscopy for patients aged\> 50 who have not had one performed in the last 5 years. * Guideline for daily diary to collect the number and the consistency of the evacuations, and whether or not they occur with effort * Recording of adverse events and concomitant therapies V0 (confirmation of possession of selection criteria): * Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate) * Randomization 1:1 to Sollievo Fisiolax or Placebo * Blood and fecal sample collection for the evaluations of the exploratory objectives * Compliance of the daily diary * Administration of questionnaires: Gastrointestinal Quality of Life Index (GIQLI), PAC-SYM * Any changes in concomitant therapies and any adverse events will be recorded. V1 (end of treatment or discontinuation before study / treatment time; 4 weeks after V0): * Physical examination, including measurement of anthropometric parameters and vital signs (height, weight, diastolic / systolic pressure, heart rate) * Returned the Investigational product * Blood and fecal sample collection for the evaluations of the exploratory objectives. * Blood tests: glycemia, creatinine, complete blood count with formula, ALT, AST, ALP, calcium, potassium, sodium, C reactive protein, total bilirubin. Urinalysis. * Blood sampling for the screening of HIV, HCV, HBV and TPHA * Check of daily diary * Administration of questionnaires: Gastrointestinal Quality of Life Index (GIQLI), PAC-SYM * Any changes in concomitant therapies and any adverse events will be recorded

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DEVICE	Sollievo Fisiolax	Class IIb Medical Device
OTHER	Sollievo Fisiolax Placebo	Placebo

Timeline

• Start date: 2021-11-09
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2022-01-14
• Last updated: 2023-07-14

Locations

2 sites across 1 country: Italy