NCT06502509Completed
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
Source: ClinicalTrials.gov · Last updated 16 Jul 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 7 Feb 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 3 Jun 2024
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, Taiwan
- Diseases
- Schizophrenia
- NCT number
- NCT06502509
What you commit to
- Study type: Interventional
- Participants enrolled: 80
- From 11 Mar 2024 to the primary completion date, 3 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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:
- 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.
Age in the registry: 20 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tsao-Tun Psychiatric Center Coordinator of this site? Confirm its status | Caotun | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.