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

NCT ID: NCT06502509

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2024-07-08

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.

Conditions

Schizophrenia; Constipation; Kombucha Tea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

interventional (Lemon kombucha tea) arm

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DIETARY_SUPPLEMENT

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

controlled (Lemon tea) arm

Group Type: PLACEBO_COMPARATOR

Lemon tea

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Lemon tea

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHYUAN JEOU RONG ENTERPRISE CO., LTD

UNKNOWN

Sponsor Role: collaborator

TsaoTun Psychiatric Center, Department of Health, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

An-Yu Hong

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

An-Yu Hong

Role: PRINCIPAL_INVESTIGATOR

Tsao-Tun Psychiatric Center, Ministry of Health and Welfare

Ying-Jyun Shih

Role: PRINCIPAL_INVESTIGATOR

Tsao-Tun Psychiatric Center, Ministry of Health and Welfare

Locations

Tsao-Tun Psychiatric Center

Caotun, , Taiwan

Countries

Taiwan

Other Identifiers

TTPC-113015

Identifier Type: -

Identifier Source: org_study_id