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NCT Number: NCT05638269

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

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.

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Key information

Conditions

Essential Hypertension Acute Coronary Syndrome Adrenal Gland Diseases Adrenocortical Hyperfunction Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Chronic Disease Chronic Kidney Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Epilepsy Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Heart Diseases Hyperaldosteronism Hypertension Kidney Diseases Liver Cancer Liver Diseases Liver Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Male Urogenital Diseases Myocardial Ischemia Nasopharyngeal Cancer Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngeal Neoplasms Primary Aldosteronism Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Subclinical hypothyroïdism Thoracic Neoplasms Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emergency General Hospital, Chaoyang, Beijing Municipality, China

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About this study

Many studies demonstrate that microbial dysbiosis has been linked to many human pathologies. However, the current understanding of the identification of the disease-associated microbiome signatures remains limited, largely owing to the heterogeneity of microbial community structures which are shaped by the host. Undoubtedly, profiles of microbial biomarkers require validation in large, independent, population-based cohorts from different districts. Based on these, the investigator plan to organize a multicentric cross-sectional cohort, not only to systematically characterize the gut microbiota of various critical chronic diseases, such as liver cancer, gastric cancer, pancreatic cancer, lung cancer, nasopharyngeal cancer, hypertension, acute coronary syndrome, primary aldosteronism, epilepsy, chronic kidney disease, and subclinical hypothyroidism but also to compare the similarities and differences of the microbiome signatures linked to different regions and different diseases and to further investigate their impacts on microbiota-based diagnostic models. In this study, for each kind of disease, the investigators expect to recruit 500 patients with a confirmed diagnosis and 500 sex- and age-matched controls, to record their information related to demography, body measurement, lifestyle, diet, medication, diseases, and biochemistry, and to collect their feces, saliva, urine and blood samples.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

No intervention

Other

Observational studies, no intervention

Primary outcomes

  1. microbiome

    Time frame: baseline

    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.

Secondary outcomes

  1. biochemistry

    Time frame: baseline

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

  2. metabonomics

    Time frame: baseline

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

  3. proteomics

    Time frame: baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiahui Zhang

CONTACT

[email protected]

13049139791

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Dec 6, 2022
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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