Kombucha Tea for Improving Defecation in Patients With Schizophrenia- a Randomized Controlled Study
NCT Number: NCT06502509
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Schizophrenia|Constipation|Kombucha Tea
Interventions: DIETARY_SUPPLEMENT: Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon)|DIETARY_SUPPLEMENT: Lemon tea
Sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
Collaborators: CHYUAN JEOU RONG ENTERPRISE CO., LTD
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-03-11
Completion Date: 2024-07-08
Locations: Tsao-Tun Psychiatric Center, Caotun, 54249, Taiwan

Summary:
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.

Primary Outcome Measures: The subjective amelioration of stool passage, The subjective amelioration of stool passage: the participants' perceived overall ease of feces on a VAS scale., 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., The objective outcome will be assessed at baseline, week 4, 8 and 12 (endpoint).
Secondary Outcome Measures: 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., 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., 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., The participants' perceived flatulence, ease and frequency of stool passage will be assessed weekly from Week 1 to Week 12.
Other Outcome Measures: Demographic data, Demographic data including sex, body metrics, past medical and allergic history, and other information related with this study will be assessed by research assistants., Demographic data will be assessed at baseline.|Medication list, Medication list of the participants will be obtained and assessed by research pharmacists, and all the medications will be recorded and categorized according to the anatomical therapeutic chemical (ATC) classification. The defined daily dose (DDD) of psychotropic and laxative agents will specifically be calculated., Medication list of the participants will be assessed at baseline, Week 4, Week 8 and the endpoint (Week 12).|Psychiatric condition, Psychiatric condition will be assessed with brief psychiatric rating scale (BPRS) by psychiatrists., Psychiatric condition will be assessed at baseline, Week 8 and Week 12.|Cognitive condition, Cognitive condition will be assessed with Montreal cognitive assessment (MoCA) by clinical psychologists., Cognitive condition will be assessed at baseline, Week 8 and Week 12.|Level of physical activity, Level of physical activity will be assessed according to metabolic equivalents (METs) by occupational therapists., Level of physical activity will be assessed at baseline, Week 8 and Week 12.