BridgeMD
New treatment option for Functional Constipation (FC)
Official title 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
ClinicalTrials.gov ID: NCT07082673
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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)
You likely can't join if
- pregnancy
- lactation
- HIV positive
- do not meet inclusion criteria.
See the full eligibility 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
- pregnancy
- lactation
- HIV positive
- do not meet inclusion criteria.
The study team makes the final eligibility decision.
Where it's taking place
- Naples, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Naples, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.