A Multicentre Study on Features of the Gut Microbiota of Patients With Critical Chronic Diseases in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorZhujiang Hospital

About this trial

The human gut microbiome has been associated with many health factors but variability between studies limits the exploration of effects between them. This study aims to systematically characterize the gut microbiota of various critical chronic diseases, compare the similarities and differences of the microbiome signatures linked to different regions and diseases, and further investigate their impacts on microbiota-based diagnostic models.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

aged 18-75 years;

living in the province where the hospital is located in the last three years;

with a medical diagnosis of one of the target diseases;

willing to provide written informed consent.

Disqualifiers

female in pregnancy or lactation(unless the subject is pregnant women);

with medical diagnoses of other serious illnesses;

with a history of bariatric surgery or intestinal resection, except for appendectomy;

individual who was treated with drugs in the preceding 1 month, including antibiotics, metformin, statins, acid inhibitor, probiotics, and probiotics; individuals having consumed yogurt more than 3 times in the preceding 1 month; heavy drinkers who have consumed more than 4 taels of liquor or 1000ml of beer; frequent alcohol consumers who have drunk per week in the last month.

Trial population

All the patients with essential Hypertension, liver cancer, nasopharyngeal cancer, pancreatic cancer, lung cancer, chronic kidney disease, acute coronary syndrome, epilepsy, gastric cancer, primary aldosteronism or subclinical hypothyroidism hospitalized in our participant hospitals will be eligible to be enrolled. Also, their age- and sex-matched controls making a physical examination in the same hospital will be eligible to be enrolled.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • no intervention

    Other intervention

    Observational studies, no intervention

Treatment groups

12,000 Participants
are divided into 2 treatment groups
Group A: disease group1 intervention
Group B: control group1 intervention

Trial outcomes

Primary outcomes

1

microbiome

The microbial composition of the stool and saliva samples was determined by 16S rRNA (ribosomal ribonucleic acid) gene sequencing analysis and metagenomics. Comparison of microbial abundance and diversity of healthy volunteers and patients with various diseases.

Time frame
baseline

Secondary outcomes

1

biochemistry

Comparison of serum markers of healthy volunteers and patients with various diseases.

Time frame
baseline
2

metabonomics

Comparison of metabolites of healthy volunteers and patients with various diseases.

Time frame
baseline
3

proteomics

Comparison of peptides of healthy volunteers and patients with various diseases using mass spectrometry.

Time frame
baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

National Natural Science Foundation of China

Collaborator