ACTRN12620000991910终止未知
Double-blind, placebo-controlled, cross-over trial of LivauxTM for the treatment of constipation and microbiome restoration in Parkinson’s disease.
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 14
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 o limit（—）
- 性别
- All
入选标准
- •1.Diagnosis of Parkinson’s disease according to UK Parkinson’s Disease Society Brain Bank Diagnostic Criteria
- •2.Currently meet ROME IV criteria for functional constipation
- •3.Experience 3 or fewer bowel motion days per week
- •4.18 years or older
- •5.BMI range 19-35
- •6.Prepared to maintain current dietary habits for the duration of the study
排除标准
- •1.Allergy to Kiwifruit
- •2.Allergy to latex
- •3.Clinically significant (as defined by local PI) gastrointestinal disorders not limited to:
- •Inflammatory Bowel Disease
- •History of major GI surgery
- •Structural or metabolic diseases affecting GI system
- •4.Other identifiable cause of constipation such as other neurological diseases, peripheral neuropathy, iatragenic constipation
- •5.Clinically significant or respiratory, cardiac failure or other concurrent medical conditions as defined by local PI
- •6.Current or recent use (within 2 weeks of baseline) of probiotics including
- •Probiotic yoghurt or probiotic yoghurt drinks,
- •fermented foods such as sauerkraut, tempeh, kimchi, miso, pickles
- •fermented drinks such as kombucha
- •7.Current or recent use (within 2 weeks of baseline) of the following medications:
- •Opiate analgesics
- •Drugs with a low therapeutic index (warfarin, digoxin)
- •Antacids containing magnesium or aluminium salts
- •Anticholinergics
- •Antibiotics (within 6 weeks of baseline)
- •SSRIs, SNRIs, or Tricyclic antidepressants (unless on a stable dosing regime)
- •8.History of laxative abuse
- •9.A high-fibre diet defined by >50g fibre per day
- •10.High fibre supplements
- •11.Females of child-bearing potential
研究者
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