PCOS'ta Probiyotik Müdahalesi

Sade dilde özet

Bu çalışma, polikistik over sendromu (polycystic ovary syndrome, PCOS) olan kadınlarda probiyotik takviyesinin ve Metformin'in etkilerini karşılaştırmalı olarak incelemektedir. Çalışmaya, Rotterdam ölçütlerine göre PCOS tanısı almış kadınlar dahil edilmiştir. Çalışma Faz 4 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 4 (Phase 4)

Durum

Tamamlandı

Sponsor

Medical University of Graz

Müdahale

Probiotic, Metformin Hydrochloride, Probiotic Placebo

Başlangıç

03.11.2020

Tahmini bitiş

16.10.2023

Ülkeler

Austria

İlgili genler

Merkezler

• Graz, Austria

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Polycystic Ovary Syndrome diagnosed based on at least two out of three rotterdam criteria: hyperandrogenism, polycystic ovarian morphology, oligo-/anovulation
* signed informed consent

Exclusion Criteria:

* Missing or withdrawn consent
* Hyperandrogenism of a cause other than PCOS (Cushing´s syndrome, hyperprolactinemia, adrenal tumours, congenital adrenal hyperplasia, rare genetic disorders)
* Pregnancy or nursing period (first 6 months after giving birth)
* Soy or other allergies with respect to study procedures
* Diabetes mellitus type 1
* Chronic inflammatory bowel disease, history of cancer in the gastrointestinal tract or acute gastrointestinal infection
* Any malignancies that required treatment within the last 3 years prior to study procedures
* Any other chronic disease requiring medical check-ups or hospital treatments at least once every three months (exception: diabetes mellitus type 2)
* Major surgery in the gastrointestinal tract (e.g. colectomy, gut segment excision with stoma surgery, Whipple´s surgery.) Surgical removal of the appendix and/or the gall bladder is NOT considered major surgery.
* Therapy with antidiabetic drugs (metformin, sulfonylureas, dipeptidyl peptidase 4 (DPP-4) inhibitors, Glucagon-like peptide 1 (GLP-1) analogs, sodium-glucose-cotransporter 2 (SGLT-2) inhibitors, insulin variants) within the last six months prior to study procedures
* Therapy with proton pump inhibitors within the last six months prior to study procedures
* Therapy with hormonal contraceptives or systemic (oral) intake of steroids within the last six months prior to study procedures
* Oral or intravenous therapy with antibiotics less than three months before the onset of study procedures
* Alcohol and/or drug abuse