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

NCT06502509 | Completed

• 1 other identifier: TTPC-113015
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• The subjective amelioration of stool passage

  The subjective amelioration of stool passage: the participants' perceived overall ease of feces on a VAS scale.

  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.

  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 weekly from Week 1 to Week 12.

• Stool form

  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 weekly from Week 1 to Week 12.

Other Outcomes (5)

• Demographic data

  Demographic data will be assessed at baseline.

• Medication list

  Medication list of the participants will be assessed at baseline, Week 4, Week 8 and the endpoint (Week 12).

• Psychiatric condition

  Psychiatric condition will be assessed at baseline, Week 8 and Week 12.

Study Arms (2)

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

Interventions

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.

interventional (Lemon kombucha tea) arm

Lemon tea 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.

controlled (Lemon tea) arm

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• TsaoTun Psychiatric Center, Department of Health, Taiwan: lead
• CHYUAN JEOU RONG ENTERPRISE CO., LTD: collaborator

Study Sites (1)

Tsao-Tun Psychiatric Center

Caotun, 54249, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia; Constipation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• An-Yu Hong

  Tsao-Tun Psychiatric Center, Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

• Ying-Jyun Shih

  Tsao-Tun Psychiatric Center, Ministry of Health and Welfare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: July 16, 2024
• Study Start: March 11, 2024
• Primary Completion: June 3, 2024
• Study Completion: July 8, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

TW (1)