Kombucha Tea for Improving Defecation in Patients With Schizophrenia- a Randomized Controlled Study

How Does Kombucha Tea Improve Difficulty During Defecation in Patients With Schizophrenia- A Randomized, Double-blinded, Placebo-controlled, Parallel Study

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 Overview

• Status: Completed
• Conditions: Schizophrenia; Constipation; Kombucha Tea
• Intervention / Treatment: Dietary supplement: Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon); Dietary supplement: Lemon tea

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Caotun, Taiwan, 54249
    • Tsao-Tun Psychiatric Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• Inclusion Criteria:

  1. 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
  2. Are currently and have been hospitalized at the psychiatric rehabilitation ward for more than 6 months, and
  3. Are at relatively stable psychiatric state and able to clearly express their perception or observed bowel conditions, and
  4. Are able to read or communicate with Mandarin or Taiwanese, and
  5. Are able to consent the agreements, and
  6. Subjectively experience difficulty in stool passage, such as decreased frequency, requiring medication or mechanic aids for defecating.

• Exclusion Criteria:

  1. Having an allergic history to fermented food, alcohol or other food, or 2. Severely impaired in cognitive performance, or 3. Having medications, antibiotics, probiotic or other fermented products that may influence gut microbiota at the time or within 3 months of the study, or 4. 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 5. Having received major gastro-intestinal surgeries, or 6. 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 7. Participating other ongoing interventional research that may interfere the implementation or the results of present studies, or 8. Being obviously unable to comply with the execution of the study, or 10. Being declared of guardianship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: interventional (Lemon kombucha tea) arm	Dietary supplement: Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon); Commercial lemon kombucha tea (Brand:E-Ben Organic Kombucha Lemon), which will be given to participants in opaque bottles for 8 weeks.
Placebo Comparator: controlled (Lemon tea) arm	Dietary supplement: Lemon tea; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
• Collaborators: CHYUAN JEOU RONG ENTERPRISE CO., LTD
• Investigators: Principal Investigator: An-Yu Hong, Tsao-Tun Psychiatric Center, Ministry of Health and Welfare; Principal Investigator: Ying-Jyun Shih, Tsao-Tun Psychiatric Center, Ministry of Health and Welfare

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Actual): June 3, 2024
• Study Completion (Actual): July 8, 2024

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Constipation
• Other Study ID Numbers: TTPC-113015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No