Efficacy and Tolerability of a Food Supplement Based on a Sea Buckthorn (Hippophae Rhamnoides L.) Extract Taken at Two Different Doses for the Management of Balance in Bowel Function in Subjects With Primary Functional Constipation: Single-center, Randomized, Placebo-controlled, Parallel-arm, Double-blind Clinical Trial
The study will aim to evaluate the efficacy and tolerability of a supplementation with Sea Buckthorn (Hippophae rhamnoides L.) at two different dosages for the management of the balance of intestinal function in subjects with primary functional constipation. The primary outcome is the improvement of the frequency of bowel movements (SCBM) in subjects with functional constipation; then the secondary outcomes are the 1) improvement in stool consistency, assessed through the Bristol Stool Form Scale (BSFS) and 2) reduction in the typical symptoms of constipation, such as feeling of bloating and abdominal distension, feeling of heaviness, abdominal pain and flatulence, improving the quality of life of the subjects affected by primary functional constipation.
• aged between 18 and 70 years
• able to understand and sign informed consent
• HIV negative test
• negative pregnancy test
• with symptoms of chronic constipation for at least 3 months (with onset at least 6 months earlier)
• absent/non-predominant abdominal pain that occurs less than one day per week and, therefore, not affected by IBS-C
• who have less than three SCBWs per week and at least one of the following conditions:
‣ in more than 25%\* of defecatory acts
⁃ lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements
⁃ feeling of incomplete evacuation in more than 25% of defecations
⁃ feeling of anorectal obstruction/blockage in more than 25% of defecations
⁃ carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations
• able to understand and comply with the requirements of the protocol