A Study on the Modulation of Gut Microbiota by Oral Sialic Acid in Healthy Subjects
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXiaolong Li
About this trial
This is a single-center prospective cohort study conducted by the Department of General Surgery at the Second Affiliated Hospital of Army Medical University (Xinqiao Hospital). The purpose of this study is to explore and clarify the effects of sialic acid intervention on gut microbiota structure, with a focus on the proliferation of pathogens (e.g., Escherichia coli, Klebsiella pneumoniae), and to develop novel prevention and treatment strategies for improving intestinal homeostasis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged between 18 and 75 years
No history of major diseases, no previous surgical history, and no history of cardiometabolic diseases (such as hypertension, diabetes mellitus, obesity, etc.)
No use of drugs that may affect gut microbiota or metabolic function (e.g., antibiotics, probiotics, immunosuppressants, etc.);
Voluntarily participate in the study and sign the informed consent form.
Disqualifiers
Comorbidities: Complicated with other severe diseases (e.g., immunodeficiency, chronic liver disease, renal insufficiency, malignant tumors, etc.).
Recent infections: Registration records indicate a history of severe infections in the recent period (within 3 months) or currently receiving anti-infective treatment.
Special populations: Pregnant women, lactating women, or women planning to become pregnant.
Poor compliance: Volunteers who are unable to cooperate with the study protocol or follow-up
Trial design
Design model
Single group
Treatments tested in this trial
Oral Sialic acid
Dietary supplementThis study employs a before-after self-control trial design, recruiting 42 volunteers to take oral sialic acid and collecting fecal samples before and after the intervention.
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: oral sialic acidExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Alterations in Gut Microbiota Structure
Gut microbiota data analysis: Perform sequence analysis and OTU clustering using QIIME2 or Mothur; compare microbial diversity (α-diversity and β-diversity) between the experimental group and control group, as well as changes in the abundance of specific microbiota (e.g., Escherichia coli, Klebsiella pneumoniae); use LEfSe analysis to screen for microbiota with significant changes after sialic acid intervention, and predict changes in microbial functions via PICRUSt
Time frame
From enrollment to the end of treatment at 2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xiaolong Li
Lead sponsor
Army Medical University, China
Sponsor institution
Source ClinicalTrials.gov