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NCT06621186Completed

Construction of an in Vitro Intestinal Microbial Ecological Simulation System for Obese People

Source: ClinicalTrials.gov · Last updated 7 Jan 2025

Brief summary (registry, in English)

About 2.6 billion people ( about 40 % of the world 's population ) are affected by overweight or obesity. The prevalence of overweight and obesity in Chinese adults has exceeded 50 %, and the prevalence is still on the rise.The gut microbiota is regarded as an endocrine organ and participates in energy balance. Diet changes can disrupt the relationship between the microbiota and the host, leading to metabolic diseases.Although human studies provide important information, there are limitations, such as the entry of complex gastrointestinal environment limiting components, the lack of dynamic microbial process information, and the uncertainty of drug side effects. In vitro methods can solve these problems, allowing dynamic sampling, standardized operation, high repeatability, and evaluation of potential toxins and pathogens. In vitro models are widely used to evaluate the effects on the human colon microbiome and to predict in vivo results.Based on the above research background, this study aims to collect fecal samples from obese people to construct an in vitro intestinal microbial ecological simulation system. This will lay an experimental foundation for further exploring the effect of specific nutrient intervention on the composition and function of gut microbiota in obese people.

Status (registry)
Completed
Study type
Observational
Enrollment
8 (actual)
First submitted
29 Sept 2024
Start date
1 Oct 2024
Primary completion date
1 Jan 2025
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Diseases
Obesity
NCT number
NCT06621186

What you commit to

  • Study type: Observational
  • Participants enrolled: 8
  • From 1 Oct 2024 to the primary completion date, 1 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Weight loss measures in the past 6 months, including but not limited to dieting, physical exercise, probiotic intervention and other medications.

Other illness

  • Previous history of intestinal disease, history of hypertension, diabetes, coronary heart disease and other chronic diseases, history of important organ disease or surgery, history of malignant tumor disease.
  • He had a history of heavy smoking and alcohol abuse.

Other

  • In the past 6 months, she took antibiotics.
  • Subjects and their families who disagreed with the study protocol.

Who the study is looking for

  • Screening in the physical examination population who intend to retain fecal samples in the physical examination center of our hospital. BMI ≥ 28, age range from 18 to 30.

Age in the registry: 18 years to 30 years · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.