SchizophreniaNCT06502509
Kombucha Tea for Improving Defecation in Patients With Schizophrenia- a Randomized Controlled Study
A study testing Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon) and Lemon tea in people with Schizophrenia and Constipation, run by TsaoTun Psychiatric Center, Department of Health, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia, Constipation, Kombucha Tea
- What is being tested?
- Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon) and Lemon tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Mar 2024to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Schizophrenia, Constipation, Kombucha Tea
- Being tested
- Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon), Lemon tea
- Medical subject headings
- Schizophrenia, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 teaDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| interventional (Lemon kombucha tea) arm | Active comparator | Not described Receives: Dietary Supplement: Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon) |
| controlled (Lemon tea) arm | Placebo comparator | Not described Receives: Dietary Supplement: Lemon tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
The subjective amelioration of stool passage
The subjective amelioration of stool passage: the participants' perceived overall ease of feces on a VAS scale.
Measured: 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.
Measured: The objective outcome will be assessed at baseline, week 4, 8 and 12 (endpoint).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: The participants' perceived flatulence, ease and frequency of stool passage will be assessed weekly from Week 1 to Week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start11 Mar 2024
- Primary completion3 Jun 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- CHYUAN JEOU RONG ENTERPRISE CO., LTD
- Responsible party
- Principal investigator, An-Yu Hong, TsaoTun Psychiatric Center, Department of Health, Taiwan
- Investigators
- An-Yu Hong, Principal investigator, Tsao-Tun Psychiatric Center, Ministry of Health and WelfareYing-Jyun Shih, Principal investigator, Tsao-Tun Psychiatric Center, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502509
- Sponsor's protocol ID
- TTPC-113015
- Status last verified
- Jul 2024
- First submitted
- 7 Feb 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Kombucha Tea Improve Difficulty During Defecation in Patients With Schizophrenia- A Randomized, Double-blinded, Placebo-controlled, Parallel Study
- ClinicalTrials.gov ID
- NCT06502509
- Acronym / sponsor ID
- TTPC-113015
- Conditions
- Schizophrenia, Constipation, Kombucha Tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TsaoTun Psychiatric Center, Department of Health, TaiwanUniversity, hospital or other
- Collaborators
- CHYUAN JEOU RONG ENTERPRISE CO., LTD
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional (Lemon kombucha tea) arm | Active comparator | Dietary Supplement: Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon) |
| controlled (Lemon tea) arm | Placebo comparator | Dietary Supplement: Lemon tea |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | interventional (Lemon kombucha tea) arm |
| Lemon teaDiluted 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. | Dietary supplement | controlled (Lemon tea) arm |
Primary outcome
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.
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.
3 secondary outcomes
Adverse effects Adverse effects Adverse effects Adverse effects
Time frame: Adverse effects will be assessed weekly from Week 1 to Week 12.
Stool form
Time frame: Stool form will be assessed daily from Week 1 to Week 12.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
An-Yu Hong principal investigator
Tsao-Tun Psychiatric Center, Ministry of Health and Welfare
Ying-Jyun Shih principal investigator
Tsao-Tun Psychiatric Center, Ministry of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commercial Kombucha tea (Brand name E-Ben Organic Kombucha Lemon) and Lemon tea in people with Schizophrenia and Constipation, run by TsaoTun Psychiatric Center, Department of Health, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The subjective amelioration of stool passage (time frame: The subjective main outcome will be assessed weekly for 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.