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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
80
Commercial lemon kombucha tea (Brand:E-Ben Organic Kombucha Lemon), which will be given to participants in opaque bottles for 8 weeks.
Diluted lemon juice with the same pH as the commercial kombucha tea as placebo, which will be given to participants in opaque bottles for 8 weeks.
Tsao-Tun Psychiatric Center
Caotun, Taiwan
The subjective amelioration of stool passage
The subjective amelioration of stool passage: the participants' perceived overall ease of feces on a VAS scale.
Time frame: The subjective main outcome will be assessed weekly for 12 weeks.
The objective amelioration of stool passage
The objective amelioration of stool passage: the frequency or the amount of laxative agent use recorded in clinical care.
Time frame: The objective outcome will be assessed at baseline, week 4, 8 and 12 (endpoint).
Adverse effects Adverse effects Adverse effects Adverse effects
Adverse effects will be assessed by the investigators with a prepared checklist developed by the research team based on the NIH Adverse Event Data Preparation Checklist and the discomforts commonly reported by the Kombucha tea drinkers from literature search.
Time frame: Adverse effects will be assessed weekly from Week 1 to Week 12.
Stool form
Stool form will be assessed with the Bristol Stool Form Scale (BSFS) by the participants' reports.
Time frame: 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 on a VAS scale.
Time frame: The participants' perceived flatulence, ease and frequency of stool passage will be assessed weekly from Week 1 to Week 12.
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