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

NCT07082673 | Recruiting

• 1 other identifier: OLIVGUT2501
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Constipation (FC)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  [Time frame: T0 (baseline), T1 (28 days of treatment)].

Secondary Outcomes (4)

• 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.

  [Time frame: T0 (baseline), T1 (28 days of treatment)].

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

  [Time frame: up to 28 days].

• Possible use of "salvage treatment".

  [Time frame: up to 28 days].

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

  [Time frame: T0 (baseline), T1 (28 days of treatment)].

Study Arms (3)

GROUP 1: subjects who will take the dietary supplement based on sea buckthorn extract 500 mg dose.

EXPERIMENTAL

GROUP 1: subjects who will take the 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).

Dietary Supplement: Sea Buckthorn (Hippophae rhamnoides L.) botanical extract 500 mg.

GROUP 2 subjects who will take the food supplement based on sea buckthorn 1500 mg dose.

EXPERIMENTAL

GROUP 2 subjects who will take the food supplement based on sea buckthorn (Hippophae rhamnoides L.), at a dose of 1500 mg - DOSE B (3 capsules of supplement).

Dietary Supplement: Sea buckthorn (Hippophae rhamnoides L.) 1500 mg.

GROUP 3 subjects who will take placebo.

PLACEBO COMPARATOR

GROUP 3 subjects who will take placebo (3 capsules of placebo).

Dietary Supplement: Placebo

Interventions

Sea Buckthorn (Hippophae rhamnoides L.) botanical extract 500 mg. DIETARY_SUPPLEMENT

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).

GROUP 1: subjects who will take the dietary supplement based on sea buckthorn extract 500 mg dose.

Sea buckthorn (Hippophae rhamnoides L.) 1500 mg. DIETARY_SUPPLEMENT

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

GROUP 2 subjects who will take the food supplement based on sea buckthorn 1500 mg dose.

Placebo DIETARY_SUPPLEMENT

Placebo (3 capsules of placebo).

GROUP 3 subjects who will take placebo.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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)
• 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

You may not qualify if:

• pregnancy
• lactation
• HIV positive

Sponsors & Collaborators

• ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL: lead

Study Sites (1)

COMEGEN Soc. Coop. Sociale

Napoli, 80126, Italy

RECRUITING

Central Study Contacts

Alessandra Baldi

CONTACT

+393483854114; alessandra.baldi.alimenti@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, placebo-controlled, parallel-arm, double-blind clinical trial.

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: July 24, 2025
• Study Start: July 24, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)