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Study on the correlation between clinical characteristics and "microbiota-gut-brain" axis in patients with obesity

Study on the correlation between clinical characteristics and "microbiota-gut-brain" axis in patients with obesity

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100247
Enrollment
Unknown
Registered
2025-04-07
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

Obesity

Interventions

Observation Group:None

Sponsors

Hubei Province Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1.Inclusion Criteria for the Obesity Group: (1)Meet the diagnostic criteria for obesity (Body Mass Index >= 28.0 kg/m²); (2)Aged 18-50 years, right-handed; (3)High school education or above, capable of completing questionnaire surveys; (4)No metal implants in the body and no contraindications for MRI, such as claustrophobia; (5)Normal electrocardiogram (ECG) results; (6)No intake of medications that may affect gut microbiota in the past three months, such as Lactobacillus tablets, Bifidobacterium quadruple viable tablets, Simotang, or probiotics; (7)Signed informed consent and voluntary participation in the study; Note: All seven criteria must be met for inclusion in the study. 2.Inclusion Criteria for the Healthy Control Group: (1)Body Mass Index < 24.0 kg/m²; (2)Aged 18-50 years, right-handed; (3)High school education or above, capable of completing questionnaire surveys; (4)Provide a health examination report from the past six months, with no diagnosed diseases; (5)No metal implants in the body and no contraindications for MRI, such as claustrophobia; (6)Normal electrocardiogram (ECG) results; (7)No intake of medications that may affect gut microbiota in the past three months, such as Lactobacillus tablets, Bifidobacterium quadruple viable tablets, Simotang, or probiotics; (8)Signed informed consent and voluntary participation in the study; Note: All eight criteria must be met for inclusion in the study.

Exclusion criteria

Exclusion criteria: 1.Exclusion Criteria for the Obesity Group: (1)Secondary obesity caused by hypothyroidism, Cushing's syndrome, adrenal hyperfunction, polycystic ovary syndrome, etc; (2)Use of medications significantly affecting body weight in the past three months, including:Hormonal drugs (glucocorticoids such as dexamethasone, hydrocortisone, prednisone, methylprednisolone; sex hormones, growth hormones, etc.), Antipsychotics, antidepressants, antiepileptic drugs, hormonal contraceptives; (3)History of surgical or device-based obesity interventions (e.g., gastric banding, intragastric balloon) or planned surgery within six months; (4)Participation in weight loss treatments in the past three months, including medication (e.g., orlistat, metformin, semaglutide) or structured weight loss programs; (5)Body weight fluctuation of more than 5 kg in the past three months; (6)History of mental disorders, including schizophrenia, depression, somatization disorders, suicidal behavior, diagnosed eating disorders (e.g., binge eating disorder, anorexia), or long-term use of psychiatric medications; (7)Severe comorbidities affecting the heart, lungs, brain, liver, kidneys, or other organ systems, including but not limited to persistent renal or hepatic insufficiency, congestive heart failure, unstable angina, myocardial infarction, or stroke in the past six months, hematological disorders, progressive malignancies, or other severe wasting diseases; (8)MRI findings indicating cerebrovascular disease, epilepsy, tumors, or other organic brain lesions; (9)Cognitive impairment as indicated by the Mini-Mental State Examination (MMSE); (10)Pregnant or breastfeeding women, or those planning to conceive within six months; (11)Participation in other clinical research trials within the past six months; Note: Participants meeting any of the above criteria will be excluded. 2.Exclusion Criteria for the Healthy Control Group: (1)History of mental disorders, including schizophrenia, depression, somatization disorders, suicidal behavior, diagnosed eating disorders (e.g., binge eating disorder, anorexia), or long-term use of psychiatric medications; (2)Use of medications significantly affecting body weight in the past three months, including:Hormonal drugs (glucocorticoids such as dexamethasone, hydrocortisone, prednisone, methylprednisolone; sex hormones, growth hormones, etc.), Antipsychotics, antidepressants, antiepileptic drugs, hormonal contraceptives; (3)Body weight fluctuation of more than 5 kg in the past three months; (4)MRI findings indicating cerebrovascular disease, epilepsy, tumors, or other organic brain lesions; (5)Cognitive impairment as indicated by the Mini-Mental State Examination (MMSE); (6)Pregnant or breastfeeding women; (7)Participation in other clinical research trials within the past six months; Note: Participants meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Functional magnetic resonance data;

Secondary

MeasureTime frame
Body Shape Indicator;TCM body constitution types assessment;Behavioral analyses;brain-gut peptide;intestinal microbiota;heart rate variability;Clinical scale assessment;

Countries

China

Contacts

Public ContactZhongyu Zhou

Hubei Province Hospital of Traditional Chinese Medicine

405417101@qq.com+86 27 8892 9226

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026