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

Condition(s) studied

Investigational drug(s) / intervention(s)

Sea Buckthorn (Hippophae rhamnoides L.) botanical extract 500 mg.: Dietary supplement based on sea buckthorn extract (Hippophae rhamnoides L.) at a dose of 500 mg - DOSE A (1 capsule of supplement + 2 capsules of placebo).

Sea buckthorn (Hippophae rhamnoides L.) 1500 mg.: Dietary supplement based on sea buckthorn (Hippophae rhamnoides L.), at a dose of 1500 mg - DOSE B (3 capsules of supplement).

Placebo: Placebo (3 capsules of placebo).

Study 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

Primary outcome measure(s)

• Evaluate the efficacy of the sea buckthorn-based dietary supplement in improving the frequency of Spontaneous Complete Bowel Movement (SCBM). — [Time frame: T0 (baseline), T1 (28 days of treatment)].
  Frequency of Spontaneous Complete Bowel Movement (SCBM), defined by EMA as an appropriate primary endpoint in the clinical evaluation of the efficacy of active ingredients for chronic functional constipation as it incorporates the concept of spontaneity without taking any salvage treatment (drugs or any other laxative, including dietary supplements, enemas or suppositories) within 24 hours before the bowel movement, as well as the completeness of the bowel movement. EVALUATION METHOD: Average value of the number of SCBMs/week in the previous month: 1. referred by the subject at the recruitment visit (T0) and reported by the investigator physician on the patient record (Case Reporting Form - CRF), and 2. calculated at the final visit (T1) on the basis of what the subject reported in the bowel function diary.

Trial sites (1)

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