A Study on the Modulation of Gut Microbiota by Oral Sialic Acid in Healthy Subjects

NCT07162662 | Recruiting DMC

• 2 other identifiers: 2025-247-022019R68
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Taking Sialic Acid to Regulate the Gut Microbiota; Healthy

Keywords

Oral Sialic Acid; Gut Microbiota; Healthy

Outcome Measures

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

  From enrollment to the end of treatment at 2 weeks

Study Arms (1)

oral sialic acid

EXPERIMENTAL

This 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.

Dietary Supplement: Oral Sialic acid

Interventions

Oral Sialic acid DIETARY_SUPPLEMENT

This 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.

oral sialic acid

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xiaolong Li: lead

Study Sites (1)

Second Affiliated Hospital of Army Medical University

Chongqing, Chongqing Municipality, 400037, China

RECRUITING

MeSH Terms

Interventions

N-Acetylneuraminic Acid

Intervention Hierarchy (Ancestors)

Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Amino Sugars; Carbohydrates

Central Study Contacts

Xiaolong Li, MD

CONTACT

+86 15025326575; 917304077@qq.com

Guangsheng DU, MD

CONTACT

+86 18716286196; guangsheng_du@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Model Details: 1. Intervention: Oral administration of bird's nest peptide N-acetylneuraminic acid beverage produced by Huaxi Dankang Jiuhe Biotechnology Co., Ltd., with a daily dose of 500 mg (total 125ml) for 14 consecutive days. 2. After volunteers are enrolled, fecal samples (5-7g) are collected before oral intervention. Immediately after collection, the fecal samples are stored at -80°C in the Department of General Surgery Laboratory for subsequent DNA extraction , gut microbiota analysis (16S rRNA sequencing) and Fecal Microbiota Transplantation (FMT) into mice (colorectal anastomosis model). 3. Fourteen days after oral intervention, fecal samples (5-7g) are collected from the volunteers. Immediately after collection, the fecal samples are stored at -80°C in the Department of General Surgery Laboratory for subsequent DNA extraction, gut microbiota analysis (16S rRNA sequencing) and Fecal Microbiota Transplantation (FMT) into mice (colorectal anastomosis model).

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: September 9, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-09

Locations

CN (1)