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Trial registered on ANZCTR


Registration number
ACTRN12618000965202
Ethics application status
Approved
Date submitted
2/06/2018
Date registered
7/06/2018
Date last updated
22/04/2020
Date data sharing statement initially provided
8/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Human microbiota in the gastrointestinal disease: Clinical relationships
Scientific title
Human microbiota: A prospective study involving integrated multi-omics approach in analysis of clinical gastrointestinal diseases
Secondary ID [1] 295080 0
None
Universal Trial Number (UTN)
U1111-1214-9657
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysbiosis 308132 0
Multidrug-resistant bacteria colonization 308133 0
Neutropenic enterocolitis/ colitis 308134 0
Infectious colitis(including Clostridium difficile, and virus) 308135 0
Ischemic colitis 308136 0
Condition category
Condition code
Oral and Gastrointestinal 307169 307169 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 307170 307170 0 0
Other infectious diseases
Infection 307171 307171 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We will recruit the patients, who seeking medical advice due to extra-luminal diseases, upper gastrointestinal bleeding, or health examination, with the risk factors of developing the targeted gastrointestinal disease in a single medical center. We will explain the study protocol to the subjects in the outpatient department, emergency room, general ward, and intensive care units. After we acquired the informed consent, we will collect the baseline feces or saliva initially. Afterwards, we collect the feces or saliva every three days during the first 18 days, once 28 days after the commencement, and once per month between day 28 to 72. Besides, we will collect the serum blood initially and once on day 9 to 18, if blood sampling was conducted according to the clinical demands. We will collect the ascites or mucosal biopsy sample (from esophagogastroduodenoscopy or colonoscopy), if the procedure is conducted according to the clinical demands.
All sample acquired will be preserved for marker gene, metagenome, and metatranscriptome analysis. Besides, we may access the other inflammatory or disease-specific biomarkers. The electronic medical records were included into data analysis.
Intervention code [1] 301408 0
Early Detection / Screening
Intervention code [2] 301409 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306131 0
Fecal microbiota changes during the development of the targeted gastrointestinal diseases, accessed by 16S metagenome (16S rRNA of bacteria or archaea) and/or shotgun metagenome analysis by performing next-generation sequencing on fecal DNA samples.
Timepoint [1] 306131 0
Baseline(Day 0), every three days during the first 18 days, once 28 days after the commencement, and once per month between day 28 to 72
Primary outcome [2] 306132 0
Fecal microbiota changes between patients with or without the development of the targeted gastrointestinal diseases, accessed by 16S metagenome (16S rRNA of bacteria or archaea) and/or shotgun metagenome analysis by performing next-generation sequencing on fecal DNA samples.
Timepoint [2] 306132 0
Baseline(Day 0), every three days during the first 18 days, once 28 days after the commencement, and once per month between day 28 to 72
Secondary outcome [1] 347663 0
Saliva microbiota changes between patients with or without the development of the targeted gastrointestinal diseases, accessed by 16S metagenome (16S rRNA of bacteria or archaea) and/or shotgun metagenome analysis by performing next-generation sequencing on salivary DNA samples.
Timepoint [1] 347663 0
Baseline(Day 0), every three days during the first 18 days, once 28 days after the commencement, and once per month between day 28 to 72
Secondary outcome [2] 347664 0
Saliva microbiota changes during the development of the targeted gastrointestinal diseases, accessed by16S metagenome (16S rRNA of bacteria or archaea) and/or shotgun metagenome analysis by performing next-generation sequencing on salivary DNA samples.
Timepoint [2] 347664 0
Baseline(Day 0), every three days during the first 18 days, once 28 days after the commencement, and once per month between day 28 to 72
Secondary outcome [3] 347665 0
Other specimens(including blood, ascites, mucosal biopsy sample) between patients with or without the development of the targeted gastrointestinal diseases, accessed 16S metagenome (16S rRNA of bacteria or archaea) and/or shotgun metagenome analysis by performing next-generation sequencing on fecal DNA samples.
Timepoint [3] 347665 0
During the study period, if any specimens could be acquired, we would conduct analysis.
Secondary outcome [4] 347807 0
Other specimens(including blood, ascites, mucosal biopsy sample) during the development of the targeted gastrointestinal diseases, accessed by 16S metagenome (16S rRNA of bacteria or archaea) and/or shotgun metagenome analysis by performing next-generation sequencing on fecal DNA samples.
Timepoint [4] 347807 0
During the study period, if any specimens could be acquired, we would conduct analysis.
Secondary outcome [5] 347808 0
All-cause mortality as assessed by data linkage to medical records
Timepoint [5] 347808 0
Day 28 post-commencement
Secondary outcome [6] 347809 0
Body weight changes, according to the medical records
Timepoint [6] 347809 0
Baseline(Day 0), and day 14 post-commencement
Secondary outcome [7] 347810 0
Sequential organ failure assessment score changes, according to the medical records
Timepoint [7] 347810 0
Baseline(Day 0), and day 14 post-commencement

Eligibility
Key inclusion criteria
1. Unexposed to antibiotics in the preceding 6 months
2. Seeking medical advice due to extra-luminal diseases, upper gastrointestinal bleeding, or health examination
3. Aged above 20
(Remark: The participants seeking for health examination, e.g. esophagogastroduodenoscopy or colonoscopy can have risk factors, such as overweight, recovery from recent gastrointestinal bleeding without sequelae, and bowel habit changes without overt diagnosis after detailed survey. Because they are not sick, they could be considered as “health people” in this study.)
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant
2. HIV carrier

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
7/06/2018
Actual
7/06/2018
Date of last participant enrolment
Anticipated
Actual
9/08/2018
Date of last data collection
Anticipated
Actual
31/08/2018
Sample size
Target
100
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 10526 0
Taiwan, Province Of China
State/province [1] 10526 0

Funding & Sponsors
Funding source category [1] 299660 0
Government body
Name [1] 299660 0
Ministry of Science and Technology
Country [1] 299660 0
Taiwan, Province Of China
Primary sponsor type
Government body
Name
Ministry of Science and Technology
Address
106, Sec. 2, Heping E. Rd., Taipei 10622, Taiwan, R.O.C.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 298990 0
None
Name [1] 298990 0
Address [1] 298990 0
Country [1] 298990 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300559 0
National Cheng Kung University Hospital Institutional Review Board
Ethics committee address [1] 300559 0
No.138 Sheng-Li Road, Tainan, Taiwan R.O.C., 704
Ethics committee country [1] 300559 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 300559 0
Approval date [1] 300559 0
23/05/2018
Ethics approval number [1] 300559 0
A-ER-107-097

Summary
Brief summary
Background:
The number of microbes in the human body outnumbers the number of human cells approximately 10-fold. The unculturability and difficulty in analysis render microbiota to be neglected in the daily clinical practice. Furthermore, most microbiomes studies focused on cross-sectional methods, and the longitudinal studies, that initiate before one specific disease develops, are scanty. In the field of gastroenterology, there was close relationship between microbiota and many gastrointestinal diseases, and associated treatments are advancing. We can hardly overemphasized the importance of microbiomes studies in the research of gastrointestinal diseases.

Aim:
To study the human microbiota changes prospectively during the development in the gastrointestinal disease

Method:
We will recruit the patients, who seeking medical advice due to extra-luminal diseases, upper gastrointestinal bleeding, or health examination, with the risk factors of developing the targeted gastrointestinal disease in a single medical center. We will explain the study protocol to the subjects in the outpatient department, emergency room, general ward, and intensive care units. After we acquired the informed consent, we will collect the baseline feces or saliva initially. Afterwards, we collect the feces or saliva every three days during the first 18 days, once 28 days after the commencement, and once per month between day 28 to 72. Besides, we will collect the serum blood initially and once on day 9 to 18, if blood sampling was conducted according to the clinical demands. We will collect the ascites or mucosal biopsy sample (from esophagogastroduodenoscopy or colonoscopy), if the procedure is conducted according to the clinical demands.
All sample acquired will be preserved for marker gene, metagenome, and metatranscriptome analysis. Besides, we may access the other inflammatory or disease-specific biomarkers. The electronic medical records were included into data analysis.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2761 2761 0 0
/AnzctrAttachments/375251-IRB_proof.pdf (Ethics approval)

Contacts
Principal investigator
Name 84062 0
Dr Tien-Ching Lin
Address 84062 0
No. 138, Sheng-Li Road, Tainan, Taiwan, 704
Country 84062 0
Taiwan, Province Of China
Phone 84062 0
+886-6-2353535 #5382
Fax 84062 0
+886-6-2007534
Email 84062 0
[email protected]
Contact person for public queries
Name 84063 0
Tien-Ching Lin
Address 84063 0
No. 138, Sheng-Li Road, Tainan, Taiwan, 704
Country 84063 0
Taiwan, Province Of China
Phone 84063 0
+886-6-2353535 #5382
Fax 84063 0
+886-6-2007534
Email 84063 0
[email protected]
Contact person for scientific queries
Name 84064 0
Tien-Ching Lin
Address 84064 0
No. 138, Sheng-Li Road, Tainan, Taiwan, 704
Country 84064 0
Taiwan, Province Of China
Phone 84064 0
+886-6-2353535 #5382
Fax 84064 0
+886-6-2007534
Email 84064 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.