The Beneficial Effect on the Bowel Function of a Food Supplement Based on Sea Buckthorn (Hippopha… (NCT07082673) | Clinical Trial Compass
RecruitingNot Applicable
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
Italy135 participantsStarted 2025-07-24
Plain-language 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.
Who can participate
Age range
18 Years – 70 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:
* 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.
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
Evaluate the efficacy of the sea buckthorn-based dietary supplement in improving the frequency of Spontaneous Complete Bowel Movement (SCBM).
Timeframe: [Time frame: T0 (baseline), T1 (28 days of treatment)].