Probiotic Dietary Intervention in Polycystic Ovary Syndrome (PCOS) - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Free testosterone
研究概览
简要总结
The investigators are conducting a double-blinded randomized controlled trial to determine whether a probiotic mixture is effective in reducing PCOS-related symptoms. For this purpose, 180 participants will be recruited in three intervention arms (Probiotic, Placebo and Metformin), with 60 participants per arm. The intervention period will last 6 months, with extensive medical history, blood work, urine and stool analysis at the beginning and the conclusion of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Only the probiotic and placebo are blinded, metformin is an open intervention arm
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Polycystic Ovary Syndrome diagnosed based on at least two out of three rotterdam criteria: hyperandrogenism, polycystic ovarian morphology, oligo-/anovulation
- •signed informed consent
排除标准
- •Missing or withdrawn consent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
研究组 & 干预措施
Probiotic
Probiotic product consisting of these 7 bacterial strains:
- Lactobacillus salivarius W57
- Lactobacillus casei W56
- Lactobacillus rhamnosus W71
- Lactococcus lactis W58
- Enterococcus faecium W54
- Lactobacillus plantarum W62
- Lactobacillus acidophilus W22
Additional ingredients: Corn starch, maltodextrin, fructo-oligosaccharides, galacto-oligosaccharides, polydextrose, plant proteins, potassium chloride, magnesium sulfate, bacterial strains, manganese sulfate, lactose, 2000 IU vitamin D
Participants ingest one sachet of powder (5 grams) in 200 ml of water per day for 6 months
干预措施: Probiotic (Dietary Supplement)
Placebo
Similar to probiotic product in optics and smell, less ingredients and no bacterial strains or vitamin D
Ingredients: Corn starch, maltodextrin, potassium chloride, magnesium sulphate, manganese sulphate
干预措施: Probiotic Placebo (Dietary Supplement)
Metformin
Metformin is an established drug for treating PCOS-related symptoms. The investigators are comparing the probiotic not only to a placebo group, but also to the benchmark treatment.
Participants in the metformin arm will start treatment with 500 mg daily for the first week, then increasing the dose to 2x500 mg daily for the duration of the intervention.
干预措施: Metformin Hydrochloride (Drug)
结局指标
主要结局
Free testosterone
时间窗: 6 months
Changes in free testosterone levels \[pg/ml\] in serum after intervention
次要结局
- Dehydroepiandrosterone-sulphate (DHEA-S)(6 months)
- Glucose(6 months)
- Body-mass-index (BMI)(6 months)
- Soluble cluster of differentiation (sCD14)(6 months)
- Luteinizing hormone (LH), Follicle-stimulating hormone (FSH)(6 months)
- Insulin(6 months)
- Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index(6 months)
- Glucose mean(6 months)
- Hirsutism(6 months)
- Calprotectin(6 months)
- 17-OH-estradiol(6 months)
- waist-to-hip ratio(6 months)
- Diaminooxidase(6 months)
- Stool and serum zonulin(6 months)
- Lipopolysaccharide(6 months)
- Anti-Müllerian hormone (AMH)(6 months)
- Androstenedione(6 months)
- 17-Hydroxyprogesterone (17-OH-progesterone)(6 months)
- Total testosterone(6 months)
- 25-OH-cholecalciferol(6 months)
- LH to FSH ratio(6 months)
- Sucrose-lactulose-mannitol test(6 months)
- Equol producer status(6 months)
- Insulin mean(6 months)
- Matsuda index(6 months)
- Quality of life (QOL)(6 months)
- Bacterial DNA(6 months)
- Gut lumen and mucosa microbiome composition and metagenomic profile(6 months)
- QOL(6 months)
- Phytoestrogen production(6 months)
研究者
Barbara Obermayer-Pietsch
Professor, MD
Medical University of Graz