Impact of Oral Supplementation With Bioactive Collagen Peptides and Other Functional Ingredients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age45-65
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Genitourinary Syndrome of Menopause (GSM), characterized by vaginal dryness, pain, urinary incontinence, and other symptoms, can be mitigated through both hormonal and non-hormonal treatments. Collagen peptides have shown promising results in improving skin, cartilage, and exhibiting antioxidative activities in studies. This study evaluates changes of quality of life and sexual function, related to vulvovaginal atrophy (VVA) and initial urinary incontinence (UI) in women with GSM symptoms, with the intake of a daily oral food supplement containing 2.5 g of Bioactive Collagen Peptides (BCP®) and other functional ingredients over a 16-week period . This can represent a new therapeutic option for these patients, particularly when hormonal therapy is not an option.

Eligibility criteria

Qualifiers

Menopausal women (at least 12 months since last menstrual period or bilateral oophorectomy)

Patients with Genitourinary Syndrome and the presence of vulvovaginal atrophy/vestibular trophism alteration (defined as Vaginal Health Index - VHI - less than 15; and Vestibular Trophic Health Score - VeTH - more than 5) and/or initial urinary incontinence based on patient history (stress incontinence , urge incontinence, nicturia reported by patients,) positive IU tests (Stamey score 1: loss of urine with sudden increase in abdominal pressure such as from coughing, sneezing, or laughing) and on a standardized stress test provocation [(cough test supine and in a standing position with a full bladder (300 ml)] in healthy post-menopausal women and/or positive OABSS score for overactive bladder.

Patients willing to provide Informed consent to participate in the study.

Women aged between 45 and 65 years.

Disqualifiers

Renal insufficiency or sever nephropathy.

In case of known hypersensitivity to one or more of the components contained in the food supplement.

Active or recent (30 days) genitourinary tract infection.

Abnormal uterine bleeding.

Trial design

Treatments tested in this trial

  • Collagendep

Treatment groups

No treatment groups listed

Locations

This trial has no locations