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

Evaluate the efficacy of the sea buckthorn-based dietary supplement in improving the frequency of Spontaneous Complete Bowel Movement (SCBM).

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.

Stool consistency, which together with the frequency of SCBM, has been indicated in the EMA and EFSA guidelines as an equally valid indicator of the condition of functional constipation.

EVALUATION METHOD: Bristol Stool Form Scale (BSFS), a validated instrument that assesses stool consistency on a spectrum of seven types. Type 1 and 2 stools denote hard or lumpy stools, while type 6 and 7 stools are indicative of loose or watery stools. The stools that characterize subjects with constipation are type 1 or 2. The consistency of the stool, expressed by the Bristol Scale, will be: 1) reported 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.

Assessment of the characteristic symptoms of the constipated subject: Feeling of bloating and abdominal distension, Feeling of heaviness, Abdominal pain, Flatulence (Bowel Function Diary).

Bowel Function diary (BF diary). The diary consists of: 1. parts that the subject will need to fill out at the time of bowel evacuation (date and time, BSFS) 2. parts that the subject will have to fill in every day, regardless of the occurrence of an SCBM, such as: the evaluation of the characteristic symptoms of the constipated subject (feeling of bloating and abdominal distension, feeling of heaviness, abdominal pain, flatulence), through the compilation of a 5-point Likert scale (1 no discomfort - 5 maximum discomfort), 3. the possible use of "salvage treatment", 4. recording of daily fluid intake. The extent of the symptoms, expressed through the 5-point Likert Scale, will be: 1. reported 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 on the function diary.

Possible use of "salvage treatment".

Entry in the bowel function diary (BF diary). Subjects will have to record in the diary the possible use of "salvage treatment" (drugs or any other laxative, including food supplements, enemas or suppositories) in order to improve intestinal function. Taking such treatments will not directly result in the exclusion of the subject from the study or the discontinuation of the investigational treatments, but whether or not the subject's data will be retained in the analysis of the results will be evaluated by the principal investigator. Subjects will be instructed prior to initiation of treatment on whether to take salvage treatment by the investigators. In particular, the intake of rescue treatments will be allowed if recorded in the diary and if the subject should incur a decrease of at least one SCBM per week.

Evaluation of the impact of constipation on perceived quality of life in the last 4 weeks.

Quality of Life Questionnaire (Short Form Health Survey-12 -SF-12) was developed in a multi-year study of patients with chronic conditions. It is a validated questionnaire widely used in clinical practice for self-assessment of quality of life against a generic disorder. Quality of life will be assessed through the SF-12 questionnaire score: 1. as reported by the subject at the recruitment visit (T0) and 2. as reported by the subject at the final visit (T1).