ACTRN12622000484741尚未招募未知
The effect of nutritional interventions on gut microbiome composition in adults previously treated with antibiotics
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- CSIRO
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 66 Years（—）
- 性别
- All
入选标准
- •1.Willing to provide written Informed Consent
- •2.Able to access own email inbox
- •3.Be able to attend the CSIRO nutrition clinic for around 2.5 hours on two occasions across an eight-week period.
- •4.Willing to consume their regular habitual diet throughout the study period
- •5.Adults (males and females)
- •6. =18-<66 years of age at clinic screen
- •7.BMI of =18.5 - =35 kg/m2
- •8.An episode of acute infection (any type) requiring at least one course of antibiotics in the past 3 months*
- •*Self-reported, no clinical testing will be performed
排除标准
- •1.Health conditions* that could affect gut and immune health such as gastrointestinal diseases [including, but not limited to diverticulitis, ulcerative colitis, Crohn’s disease, or coeliac disease, colostomy], type 1 or type 2 diabetes, cancer, renal or liver diseases in the last 12 months.
- •2.Immunocompromised (diagnosed with HIV, AIDS) or having an organ or bone marrow transplant in the last 12 months.
- •3.Gastrointestinal symptoms* (i.e. pain, reflux, diarrhea, or constipation), surgeries* (i.e. bariatric surgery such as gastric banding) or use of medications* (i.e. appetite suppressants (orlistat, phentermine and liraglutide), steroids (corticosteroids, progestogen, androgens and estrogens) known to potentially affect energy intake, appetite, or gastrointestinal motor function
- •4.Have a biliary disorder
- •5.Currently taking medication for hypertension and or high cholesterol
- •6.Currently taking supplements (probiotics, prebiotics, fibre, micronutrients, multivitamins, essential oils) or functional foods (fermented food, polyphenols) in the previous 4 weeks of Visit 1.
- •7.Known food allergies or intolerances to the study intervention products
- •8.Pregnant and/or lactating women
- •9.Current smoker (or history of smoking within the last six months)
- •10.History of or known presence of alcohol abuse or illicit drug use*
- •11.Received an investigational drug within 28 days prior to Visit 1 that in the opinion of the investigator may affect the applicant’s ability to participate in the study or the study results
- •*Self-reported, no clinical testing will be performed
研究者
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