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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000044236
Receipt No. R000050519
Scientific Title Effects of the combined use of hougu mixi and probiotics on intestinal flora, intestinal colonization of probiotics, and blood biochemical indicators in Chinese adults: a randomized crossover intervention trial
Date of disclosure of the study information 2021/05/17
Last modified on 2021/05/17

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Basic information
Public title Effects of the combined use of hougu mixi and probiotics on intestinal flora, intestinal colonization of probiotics, and blood biochemical indicators in Chinese adults: a randomized crossover intervention trial
Acronym hougu mixi and probiotics on health status
Scientific Title Effects of the combined use of hougu mixi and probiotics on intestinal flora, intestinal colonization of probiotics, and blood biochemical indicators in Chinese adults: a randomized crossover intervention trial
Scientific Title:Acronym hougu mixi and probiotics on health status
Region
Asia(except Japan)

Condition
Condition healthy population
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether hougumixi could improve health status among chinese adults.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The differences in serum lipid and gut microbiota changes.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 hougu mixi
Interventions/Control_2 hougu mixi plus probiotics
Interventions/Control_3 placebo plus probiotics
Interventions/Control_4 placebo
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria (1)Male and female over 18 years old;

(2)Not taking other health care products in the last 6 months.
Key exclusion criteria (1)participants who are taking health supplements in the last 6 months;
(2)with any physical diseases or mental diseases;
(3)taking antibiofic in the last 6 months;

(4)unable to complete intervention and examination over 6 months.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Kaijun
Middle name
Last name Niu
Organization Tianjin Medical University
Division name Nutrition and epidemiology institution
Zip code 300050
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
TEL +86(0)22-83336613
Email nkj0809@gmail.com

Public contact
Name of contact person
1st name Huiping
Middle name
Last name Li
Organization Tianjin Medical University
Division name Nutrition and epidemiology institution
Zip code 300050
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
TEL +86(0)22-83336613
Homepage URL
Email lihuiping1222@163.com

Sponsor
Institute Tianjin Medical University,Nutrition and epidemiology institution
Institute
Department

Funding Source
Organization JIANGZHONG PHARMACEUTICAL CO.LTD
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tianjin Medical University
Address 22 Qixiangtai Road, Heping District, Tianjin, P.R.China.
Tel +86(0)22-83336613
Email nkj0809@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 05 Month 17 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 24
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2020 Year 05 Month 30 Day
Date of IRB
2019 Year 12 Month 25 Day
Anticipated trial start date
2020 Year 06 Month 20 Day
Last follow-up date
2020 Year 12 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 17 Day
Last modified on
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050519

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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