NCT07082673 The Beneficial Effect on the Bowel Function of a Food Supplement Based on Sea Buckthorn (Hippophae Rhamnoides L.) Extract in Subjects With Primary Functional Constipation
| NCT ID | NCT07082673 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL |
| Condition | Functional Constipation (FC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2025-07-24 |
| Primary Completion | 2025-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 135 participants in total. It began in 2025-07-24 with a primary completion date of 2025-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * pregnancy * lactation * HIV positive * do not meet inclusion criteria.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07082673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Functional Constipation (FC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07082673 currently recruiting?
Yes, NCT07082673 is actively recruiting participants. Contact the research team at alessandra.baldi.alimenti@gmail.com for enrollment information.
Where is the NCT07082673 trial being conducted?
This trial is being conducted at Naples, Italy.
Who is sponsoring the NCT07082673 clinical trial?
NCT07082673 is sponsored by ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL. The trial plans to enroll 135 participants.