Clinical trial NCT06502509: Kombucha Tea for Improving Defecation in Patients With Schizophrenia- a Randomized Controlled Study
Official title: How Does Kombucha Tea Improve Difficulty During Defecation in Patients With Schizophrenia- A Randomized, Double-blinded, Placebo-controlled, Parallel Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Constipation
Kombucha Tea
Lead sponsor: TsaoTun Psychiatric Center, Department of Health, Taiwan
Sponsor class: OTHER
Collaborators: name: CHYUAN JEOU RONG ENTERPRISE CO., LTD
First posted: 2024-07-16
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: * 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.

Primary outcomes:
measure: The subjective amelioration of stool passage
timeFrame: The subjective main outcome will be assessed weekly for 12 weeks.
measure: The objective amelioration of stool passage
timeFrame: The objective outcome will be assessed at baseline, week 4, 8 and 12 (endpoint).
Secondary outcomes:
measure: Adverse effects Adverse effects Adverse effects Adverse effects
timeFrame: Adverse effects will be assessed weekly from Week 1 to Week 12.
measure: Stool form
timeFrame: Stool form will be assessed daily from Week 1 to Week 12.
measure: The participants' perceived flatulence, ease and frequency of stool passage.
timeFrame: The participants' perceived flatulence, ease and frequency of stool passage will be assessed weekly from Week 1 to Week 12.
Other outcomes:
measure: Demographic data
timeFrame: Demographic data will be assessed at baseline.
measure: Medication list
timeFrame: Medication list of the participants will be assessed at baseline, Week 4, Week 8 and the endpoint (Week 12).
measure: Psychiatric condition
timeFrame: Psychiatric condition will be assessed at baseline, Week 8 and Week 12.
measure: Cognitive condition
timeFrame: Cognitive condition will be assessed at baseline, Week 8 and Week 12.
measure: Level of physical activity
timeFrame: Level of physical activity will be assessed at baseline, Week 8 and Week 12.
Locations:
city: Caotun
country: Taiwan
facility: Tsao-Tun Psychiatric Center
Study officials:
affiliation: Tsao-Tun Psychiatric Center, Ministry of Health and Welfare
name: An-Yu Hong
role: PRINCIPAL_INVESTIGATOR
affiliation: Tsao-Tun Psychiatric Center, Ministry of Health and Welfare
name: Ying-Jyun Shih
role: PRINCIPAL_INVESTIGATOR
References: