Evaluating the impact of probiotics use on metabolism body composition, gut microbiota and immunity markers in prediabetic patients. - A randomized, blind, placebo-controlled trial.

Charikleia Stefanaki0 个研究点目标入组 50 人开始时间: 2015年5月13日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Hb1AC ranging from 5.7% to 6.4% or
•- Fasting plasma glucose concentrations ranging from 100 mg/dl to 125 mg/dl or
•- At Oral Glucose Tolerance Test within 2 hours: blood glucose ranging from 140 mg/dl to 199 mg/dl

•1.Short-bowel syndrome patients, with concurrent D-lactic acidosis.
•2.Current hospitalization for any reason.
•3.Co-morbid infection of any kind.
•4.Co-morbid hereditary and/or acquired immune system deficiency.
•5.Patients with genetic defects in insulin action, diseases of the exocrine pancreas, gestational diabetes, endocrinopathies (Cushing’s syndrome, acromegaly, glucagonoma, pheochromocytoma, somatostatinoma, aldestoronoma, hyperthyroidism), drug or chemical- induced diabetes (vacor, pentamidine, nicotinic acid, glucocorticoids, thyroid hormone, diazoxide, b-adrenergic agonists, thiazides, clozapine, protease inhibitors), or Stiffman’s syndrome.
•6.Ingestion of antibiotics < 1 month, prior enrolment and/or intake of yogurts and products containing probiotics or any immune-compromising agent, whatsoever.
•7.Diarrhoea, due to the probiotics administration, that lasts more than 3 days and/or causes severe dehydration, independently of its duration.
•8.Current detection of HBsAg, HBcAb presence and/or established diagnosis of hepatic disorders of any nature.
•9.Inability to commit to clinical trial follow-up.
•10.Atopic dermatitis.
•11.Epilepsy.
•12.Established or possible pregnancy.
•13.Presence of metal prostheses, due to orthopaedic surgery or otherwise or implanted devices such as pacemakers.
•14.Established, chronic life-threatening diseases, such as neoplasias.

发起方

Charikleia Stefanaki