How Does Kombucha Tea Improve Difficulty During Defecation in Patients With Schizophrenia- A Randomized, Double-blinded, Placebo-controlled, Parallel Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The objective amelioration of stool passage
研究概览
简要总结
Patients with schizophrenia frequently have difficulties in bowel habits due to medical adverse effects and unhealthy lifestyle, and the use of various interventions to ameliorate the problems have been noted in clinical setting. Probiotics including Kombucha tea have been proved to modulate the human gut microbiota which may help to improve the stool passage, and have been attracting the public attention across the world. However, little is known among the patients with schizophrenia. In the present study, the research team intends to evaluate effectiveness of Kombucha tea when used in the clinical settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Inpatient patients diagnosed of schizophrenia according to DSM-5 criteria with the ICD-10-CM codes of F20.x. and hold the cards for Severe Illness issued by the National Health Insurance Administration, and
- •Are currently and have been hospitalized at the psychiatric rehabilitation ward for more than 6 months, and
- •Are at relatively stable psychiatric state and able to clearly express their perception or observed bowel conditions, and
- •Are able to read or communicate with Mandarin or Taiwanese, and
- •Are able to consent the agreements, and
- •Subjectively experience difficulty in stool passage, such as decreased frequency, requiring medication or mechanic aids for defecating.
排除标准
- •1. Having an allergic history to fermented food, alcohol or other food, or
- •Severely impaired in cognitive performance, or
- •Having medications, antibiotics, probiotic or other fermented products that may influence gut microbiota at the time or within 3 months of the study, or
- •Having the illness that may affect stool passage or related with intestinal obstruction, such as severe gut disease, intestinal incarceration, tumor, inflammation, stenosis, or hemorrhoid, or
- •Having received major gastro-intestinal surgeries, or
- •Having the ongoing or history of medical illnesses, such as cancers, chronic obstructive pulmonary diseases, peripheral vascular diseases, autoimmune diseases, chronic kidney diseases, diseases involving abnormal metabolic function of visceral organs, or current infections, or
- •Participating other ongoing interventional research that may interfere the implementation or the results of present studies, or
- •Being obviously unable to comply with the execution of the study, or
- •Being declared of guardianship.
结局指标
主要结局
The objective amelioration of stool passage
时间窗: The objective outcome will be assessed at baseline, week 4, 8 and 12 (endpoint).
The objective amelioration of stool passage: the frequency or the amount of laxative agent use recorded in clinical care.
The subjective amelioration of stool passage
时间窗: The subjective main outcome will be assessed weekly for 12 weeks.
The subjective amelioration of stool passage: the participants' perceived overall ease of feces on a VAS scale.
次要结局
- Adverse effects Adverse effects Adverse effects Adverse effects(Adverse effects will be assessed weekly from Week 1 to Week 12.)
- Stool form(Stool form will be assessed daily from Week 1 to Week 12.)
- The participants' perceived flatulence, ease and frequency of stool passage.(The participants' perceived flatulence, ease and frequency of stool passage will be assessed weekly from Week 1 to Week 12.)
研究者
An-Yu Hong
Doctor
TsaoTun Psychiatric Center, Department of Health, Taiwan