Status:
COMPLETED
Kombucha Tea for Improving Defecation in Patients With Schizophrenia- a Randomized Controlled Study
Lead Sponsor:
TsaoTun Psychiatric Center, Department of Health, Taiwan
Collaborating Sponsors:
CHYUAN JEOU RONG ENTERPRISE CO., LTD
Conditions:
Schizophrenia
Constipation
Eligibility:
All Genders
20-65 years
Phase:
NA
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 be...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06502509
Start Date
March 11 2024
End Date
July 8 2024
Last Update
July 16 2024
Active Locations (1)
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1
Tsao-Tun Psychiatric Center
Caotun, Taiwan, 54249