Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors

Sleep Clinical Trial

Official title:

Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717972
• Other study ID #: YM111146EF
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2022
• Est. completion date: December 12, 2025

Study information

• Verified date: February 2023
• Source: National Yang Ming University
• Contact: I-Ching Hou, PhD
• Phone: 886-2-28267000
• Email: evidta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of Kombucha Intervention on Emotional Distress and Sleep Quality in Breast Cancer Survivors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 12, 2025
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

• Stage 0-III Breast Cancer

• No any cancer treatment in the following year

• Perceived emotional distress and poor sleep quality

• Agree to follow the protocol of this study

Exclusion Criteria:

• Stage IV Breast Cancer

• Pregnant women

• Abnormal liver, kidney, gastric, internal , immune, sleep disorder, metabolic, psychic functions and need to take the prescription medications or medical treatments regularly

• could not follow the protocol of this study

Related Conditions & MeSH terms

• Distress, Emotional
• Sleep

Intervention

Other:
• Kombucha
Kombucha is a fermented tea drink that originated in ancient Chinese civilization. It is made by combining tea, juice, and SCOBY (Symbiotic Culture of Bacteria and Yeast). During the fermentation process, the yeast in the SCOBY breaks down the sugar in the tea releasing friendly probiotic bacteria, giving kombucha its fizzy body and its sweet and tangy taste.

Locations

Country	Name	City	State
Taiwan	National Yang-Ming University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Quality Index	The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.	Change from Baseline Sleep Quality Index at Day 20
Primary	Sleep Quality Index	The Pittsburgh Sleep Quality Index, PSQI. The range of score was 0-21. The higher score and the worse sleep quality.	Change from Baseline Sleep Quality Index at Day32
Primary	Anxiety	The State-Trait Anxiety Inventory, STAI. It includes two types of anxiety. The state anxiety is considered to be individual's temporary perception toward fear, nervousness, discomfort etc. and the trait anxiety be the individual's experience on a daily basis The range of each measurement score was 20-80. Higher scores indicate greater anxiety.	Change from Baseline State-Trait Anxiety Inventory at Day20
Primary	Anxiety	The State-Trait Anxiety Inventory, STAI. It includes two types of anxiety. The state anxiety is considered to be individual's temporary perception toward fear, nervousness, discomfort etc. and the trait anxiety be the individual's experience on a daily basis The range of each measurement score was 20-80. Higher scores indicate greater anxiety.	Change from Baseline State-Trait Anxiety Inventory at Day32
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 2
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 3
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 4
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 5
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 6
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 7
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 8
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 9
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 10
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 11
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 12
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 13
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 14
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 15
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 16
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 17
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 18
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 19
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 20
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 21
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 22
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 23
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 24
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 25
Secondary	Intestinal Transit Time	Bristol Stool Form Scale, BSFS. It is a useful guide to intestinal transit time by describing the shapes and types of stools(type 1 to 7).; Type 1-2 indicate constipation, Type 3-4 are ideal stools as they are easier to pass, and Type 5-7 may indicate diarrhea and urgency.	Change from Baseline Bristol Stool Form Scale at Day 26