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Human microbiota in the gastrointestinal disease: Clinical relationships

Human microbiota: A prospective study involving integrated multi-omics approach in analysis of clinical gastrointestinal diseases

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000965202
Enrollment
12
Registered
2018-06-07
Start date
2018-06-07
Completion date
2018-08-09
Last updated
2020-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 collec

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.

Sponsors

Ministry of Science and Technology
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
20 Years to No maximum
Healthy volunteers
Yes

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.)

Exclusion criteria

1. Pregnant 2. HIV carrier

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026