Actively Recruiting
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
Led by ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL · Updated on 2025-07-30
135
Participants Needed
1
Research Sites
5 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 70 years
- Able to understand and sign informed consent
- HIV negative test
- Negative pregnancy test
- Symptoms of chronic constipation for at least 3 months with onset at least 6 months earlier
- Absent or non-predominant abdominal pain occurring less than one day per week, excluding IBS-C
- Fewer than three spontaneous complete bowel movements per week
- At least one of the following in more than 25% of defecations: lumpy or hard stools (Bristol Stool Form Scale type 1 or 2), feeling of incomplete evacuation, feeling of anorectal obstruction/blockage, or need for manual maneuvers to facilitate evacuation
- Able to comply with protocol requirements
You will not qualify if you...
- Pregnancy
- Lactation
- HIV positive
- Do not meet inclusion criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
COMEGEN Soc. Coop. Sociale
Naples, Italy, 80126
Actively Recruiting
Research Team
A
Alessandra Baldi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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