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Study on the effect of one-time alcohol intake on gut microbiota

Study on the effect of one-time alcohol intake on gut microbiota

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039048
Enrollment
Unknown
Registered
2020-10-14
Start date
2020-10-16
Completion date
Unknown
Last updated
2021-01-11

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

Conditions

The effects of alcohol on the gut

Interventions

High dose group:The alcohol intake dose of men is 0.696 g/kg, and that of women is 0.582 g/kg
Middle dose group:The alcohol intake dose is 0.525 g/kg for men and 0.433 g/kg for women.
Low dose group:The alcohol intake dose is 0.354 g/kg for men and 0.285 g/kg for women.

Sponsors

Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) The age is 18-70 years old, the ratio of male to female is 1:1, and there is no alcohol addiction or alcohol intake disorder; (2) Through the alcohol use disorder identification test (AUDIT) and CAGE test, there was no alcohol use disorder and metabolic abnormality. (3) BMI is between 18.5 and 25 kg/m2 (inclusive); (4) Be able to accept the regulations during the test and send samples on time to complete the main observation indicators. (5) Volunteers fill in written informed consent form (Attached Table 1), basic information questionnaire (Attached Table 2), dietary structure and living conditions questionnaire (Attached Table 3), and promise to cooperate with the research during the whole experiment.

Exclusion criteria

Exclusion criteria: (1) People with abnormal alcohol metabolism (such as red face, etc.); (2) Gastrointestinal infection or gastrointestinal diseases diagnosed by the hospital; (3) Having undergone major abdominal surgery, especially gastrointestinal surgery (except appendicitis or hernia surgery); (4) Any abnormal physical condition or medical condition affecting gastrointestinal tract; (5) The continuous use time of diet pills is more than one month; (6) Suffering from other types of immune system diseases, such as rheumatoid arthritis, systemic lupus erythematosus, Graves disease, psoriasis and so on; (7) Intention to be pregnant during pregnancy, lactation or research; (8) Eating yogurt, probiotic drinks, microecological preparations, dietary supplements, Chinese herbal medicines, or taking large doses of vitamins or minerals at present or in the near future (within one month) or for a long time; (9) Severe liver diseases (including chronic persistent hepatitis, liver cirrhosis or hepatitis B virus surface antigen positive coexisting with abnormal liver transaminase (the serum concentration of alanine transaminase or aspartate transaminase is 2.5 times higher than the normal upper limit); (10) Continuous use of antibiotics for more than 3 days within 3 months before being selected; Use glucocorticoid, immunosuppressive drugs or biological targeted drugs at present or in the near future (3 months) or for a long time; (11) Major changes have taken place in eating habits recently (within one month), such as starting to eat a diet rich in fiber, etc.; (12) The diseases treated with drugs include cholecystitis, peptic ulcer, urinary tract infection, acute pyelonephritis, allantois or hyperthyroidism; Pituitary dysfunction; Serious organic diseases, including cancer, coronary heart disease, myocardial infarction or stroke; Infectious diseases, including tuberculosis and AIDS; (13) Suffering from severe mental illness within 6 months before being selected; (14) Conducting other clinical research at present or in the near future (within 1 month); (15) do not meet the research requirements or researchers think that they should not participate in the research.

Design outcomes

Primary

MeasureTime frame
Metagenome of fecal microbiota;Fecal metabolomics;Isolation of specific strain;In vitro fermentation experiment;Fecal microbiota transplantation;

Countries

China

Contacts

Public ContactQixiao Zhai

School of Food Science and Technology, Jiangnan University

zhaiqixiao@jiangnan.edu.cn+86 15961760920

Outcome results

None listed

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