Sea buckthorn supplement to improve bowel function in primary functional constipation

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

This study will test whether a sea buckthorn (Hippophae rhamnoides) supplement at two different doses helps adults with primary functional constipation have more frequent, softer bowel movements and less bloating.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Istituto Farmochimico Fitoterapico: Epo Srl (Industry-sponsored)
• Locations: 1 site (Naples)
• Trial ID: NCT07082673 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled trial will assign 135 adults with primary functional constipation into three parallel groups (45 per group) to receive sea buckthorn extract 500 mg, 1500 mg, or placebo. Participants are adults aged 18–70 with chronic constipation symptoms and fewer than three spontaneous complete bowel movements per week. The primary outcome is change in spontaneous complete bowel movements (SCBM) frequency; secondary outcomes include stool consistency by the Bristol Stool Form Scale and typical constipation symptoms (bloating, abdominal distension, pain, flatulence) and quality of life. The trial uses standardized dosing and blinded allocation to compare efficacy and tolerability of the supplement versus placebo.

Who should consider this trial

Good fit: Adults aged 18–70 with primary functional constipation (chronic symptoms for ≥3 months, onset ≥6 months earlier, and ≤3 SCBMs per week with supporting symptom criteria) who can consent and attend the study site.

Not a fit: Patients who are pregnant, breastfeeding, HIV positive, have predominant abdominal pain suggestive of IBS-C, or have secondary causes of constipation are unlikely to qualify or benefit from this intervention.

Why it matters

Potential benefit: If successful, the supplement could offer a well-tolerated, plant-based option to increase bowel movement frequency and reduce constipation symptoms.

How similar studies have performed: Some small clinical and preclinical studies and traditional use suggest sea buckthorn may improve intestinal motility and stool hydration, but high-quality randomized evidence is limited.

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.

Where this trial is running

Naples

• COMEGEN Soc. Coop. Sociale — Naples, Italy (Recruiting)

Study contacts

• Study coordinator: Alessandra Baldi

Conditions Functional Constipation; Functional constipation; Food supplement; sea buckthorn; Hippophae rhamnoides L.