A 12 month randomised controlled trial to determine biomarkers from the gut microbiota as management tools for overweight and obesity

The University of Sydney0 个研究点目标入组 108 人开始时间: 2012年6月5日最近更新: 2020年1月13日

适应症

试验速览

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•Recent diagnosis of diabetes (< 3 months)
•Unstable angina or recent onset of cardiovascular disease
•Serious hepatic or renal disease
•- serum transaminases (ALT or AST) > 2.5 times upper limit of normal
•- serum creatinine > 1.5 times upper limit of normal or urinary microalbumin >40 mg/L or eGFR < 60ml/min/1.73m2
•Alcohol or illicit drug abuse
•Pregnant, breastfeeding, or planning pregnancy during the study
•Treatment for an eating disorder, weight loss medications and other drugs that affect body weight e.g. anti-psychotics, anti-depressants, or corticosteroids
•Hypothyroidism defined by elevated thyroid stimulating hormone (TSH) and low free thyroxine (fT4), or current hyperthyroidism under treatment
•Participation in another weight loss clinical trial within past 3 months
•Individuals who have lost >10% weight within past 3 months
•Inability to read and write English
•Subjects who frequently change smoking habits or who have stopped smoking within 6 months prior to screening. Those who wish to take on the advice of a 'Quit' smoking program at the time of screening will be eligible to start the trial after 3 months.
•Subjects not willing to participate in all of the specimen collection.
•Individuals with known penicillin and/or cephalosporin hypersensitivity will not be eligible for randomisation to the antibiotic treatment, however will still be eligible for entry into the trial

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