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Completed

NCT Number: NCT06502509

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

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Key information

Conditions

Schizophrenia Constipation Kombucha Tea Mental Disorders Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Signs and Symptoms, Digestive

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tsao-Tun Psychiatric Center

Caotun, 54249, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.
  • Exclusion Criteria:
  • 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.

Treatment and study plan

Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon)

Dietary Supplement

Commercial lemon kombucha tea (Brand:E-Ben Organic Kombucha Lemon), which will be given to participants in opaque bottles for 8 weeks.

Lemon tea

Dietary Supplement

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.

Primary outcomes

  1. The subjective amelioration of stool passage

    Time frame: 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.

  2. The objective amelioration of stool passage

    Time frame: 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.

Secondary outcomes

  1. Adverse effects Adverse effects Adverse effects Adverse effects

    Time frame: Adverse effects will be assessed weekly from Week 1 to Week 12.

    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.

  2. Stool form

    Time frame: Stool form will be assessed daily from Week 1 to Week 12.

    Stool form will be assessed with the Bristol Stool Form Scale (BSFS) by the participants' reports.

  3. The participants' perceived flatulence, ease and frequency of stool passage.

    Time frame: The participants' perceived flatulence, ease and frequency of stool passage will be assessed weekly from Week 1 to Week 12.

    The participants' perceived flatulence, ease and frequency of stool passage will be assessed on a VAS scale.

Other outcomes

  1. Demographic data

    Time frame: Demographic data will be assessed at baseline.

    Demographic data including sex, body metrics, past medical and allergic history, and other information related with this study will be assessed by research assistants.

  2. Medication list

    Time frame: Medication list of the participants will be assessed at baseline, Week 4, Week 8 and the endpoint (Week 12).

    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.

  3. Psychiatric condition

    Time frame: Psychiatric condition will be assessed at baseline, Week 8 and Week 12.

    Psychiatric condition will be assessed with brief psychiatric rating scale (BPRS) by psychiatrists.

  4. Cognitive condition

    Time frame: Cognitive condition will be assessed at baseline, Week 8 and Week 12.

    Cognitive condition will be assessed with Montreal cognitive assessment (MoCA) by clinical psychologists.

  5. Level of physical activity

    Time frame: Level of physical activity will be assessed at baseline, Week 8 and Week 12.

    Level of physical activity will be assessed according to metabolic equivalents (METs) by occupational therapists.

Sponsors and collaborators

Lead sponsor

TsaoTun Psychiatric Center, Department of Health, Taiwan

Other

Collaborators

  • CHYUAN JEOU RONG ENTERPRISE CO., LTD

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 16, 2024
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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