Taking Sialic Acid to Regulate the Gut MicrobiotaMFMOSANCT07162662
A Study on the Modulation of Gut Microbiota by Oral Sialic Acid in Healthy Subjects
A study testing Oral Sialic acid in people with Taking Sialic Acid to Regulate the Gut Microbiota and Healthy, run by Xiaolong Li at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Taking Sialic Acid to Regulate the Gut Microbiota, Healthy
- What is being tested?
- Oral Sialic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400037
Xiaolong Li, MD, +86 15025326575, 917304077@qq.com
Yuhao Jiang, MD, +86 17384751418, 1935247339@qq.com
About this study
Official title: Modulation of Gut Microbiota by Oral Sialic Acid: A Mechanistic Study
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.
Read the detailed description
Background：Colorectal cancer (CRC) is one of the most common gastrointestinal malignancies worldwide, ranking third in incidence and second in mortality among all cancers. Surgical resection remains the primary treatment for CRC, particularly for early- and mid-stage patients, as it effectively removes tumor tissue and prolongs survival. However, postoperative anastomotic healing failure (e.g., anastomotic leakage) is a severe complication of colorectal surgery, with an incidence rate of 5%-20%. Anastomotic leakage not only significantly increases postoperative mortality but also prolongs hospital stays, escalates medical costs, and imposes a heavy burden on both patients and healthcare systems. The pathogenesis of anastomotic leakage is complex, involving factors such as local ischemia, surgical technique, infection, and gut microbiota dysbiosis. In recent years, with advancements in microbiomics research, the role of gut microbiota in anastomotic healing has gained increasing attention.
During malignant transformation, colorectal cancer cells exhibit significantly upregulated expression of sialic acid (SA) on their cell surfaces. Sialic acid, a class of nine-carbon monosaccharides widely distributed on mammalian cell surfaces, participates in cell-cell recognition, immune regulation, and host-microbe interactions. Studies have shown that shed sialic acid from colorectal tumor cells enters the intestinal lumen, serving as a critical nutrient source for gut microbes. Notably, certain pathogens (e.g., Escherichia coli, Klebsiella pneumoniae) can utilize sialic acid as a carbon source to promote their proliferation and colonization. These pathogens may impair anastomotic healing through multiple mechanisms: first, by disrupting the intestinal mucosal barrier and exacerbating local inflammation; second, by inhibiting epithelial cell repair and delaying tissue regeneration; and third, by producing toxins or metabolites that further damage local tissues. Thus, colorectal tumor-derived sialic acid may indirectly increase the risk of postoperative anastomotic healing failure by nourishing specific pathogens.
Although existing research suggests that sialic acid from colorectal tumors influences the gut microenvironment by feeding pathogens, the specific mechanisms underlying its impact on postoperative anastomotic healing remain unclear. This hypothesis requires experimental validation. Our preliminary animal studies have demonstrated that oral administration of sialic acid impairs rectal anastomotic healing in mice by modulating gut microbiota. This finding indicates that sialic acid may affect postoperative anastomotic tissue repair and inflammatory responses by altering gut microbiota structure. However, research on the effects of sialic acid on the human gut microbiota remains limited. Based on this background, the present study aims to characterize the impact of sialic acid on gut microbiota by analyzing fecal samples collected from volunteers following oral sialic acid intervention.
Study Design： 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. Specifically, the control group specimens were fecal samples collected before oral sialic acid administration, while the experimental group specimens were fecal samples collected after oral sialic acid administration.
Primary Objective:Alterations in Gut Microbiota Structure
Key Outcomes： Data Analysis: Data extracted from electronic medical records. Statistical analysis using SPSS 22.0 (χ² test for categorical data, t-test for normally distributed continuous data; significance p<0.05).
Ethics: Approved by the institutional ethics committee. Conducted in accordance with the Declaration of Helsinki and Chinese regulations. Patient privacy and data confidentiality are prioritized.
Timeline: Patient data collection and analysis (Sep 2025-Aug 2026); Statistical analysis and manuscript preparation (Sep-Dec 2025).
Significance: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
- Being tested
- Oral Sialic acid
- Keywords
- Oral Sialic Acid, Gut Microbiota, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Sialic acidDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Oral Sialic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start10 Sep 2025
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Taking Sialic Acid to Regulate the Gut MicrobiotaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiaolong Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaolong Li, Army Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162662
- Sponsor's protocol ID
- 2025-247-02
- Other IDs
- 2019R68, 2025-247-02
- Acronym
- MFMOSA
- Status last verified
- Sep 2025
- First submitted
- 13 Aug 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We are currently planning to conduct a series of studies. As data sharing will be postponed until all studies have been completed, the data will not be made available at this time.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Gut Microbiota by Oral Sialic Acid: A Mechanistic Study
- ClinicalTrials.gov ID
- NCT07162662
- Acronym / sponsor ID
- MFMOSA / 2025-247-02
- Keywords
- Oral Sialic Acid, Gut Microbiota, Healthy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Xiaolong LiUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background：Colorectal cancer (CRC) is one of the most common gastrointestinal malignancies worldwide, ranking third in incidence and second in mortality among all cancers. Surgical resection remains the primary treatment for CRC, particularly for early- and mid-stage patients, as it effectively removes tumor tissue and prolongs survival. However, postoperative anastomotic healing failure (e.g., anastomotic leakage) is a severe complication of colorectal surgery, with an incidence rate of 5%-20%. Anastomotic leakage not only significantly increases postoperative mortality but also prolongs hospital stays, escalates medical costs, and imposes a heavy burden on both patients and healthcare systems. The pathogenesis of anastomotic leakage is complex, involving factors such as local ischemia, surgical technique, infection, and gut microbiota dysbiosis. In recent years, with advancements in microbiomics research, the role of gut microbiota in anastomotic healing has gained increasing attention.
During malignant transformation, colorectal cancer cells exhibit significantly upregulated expression of sialic acid (SA) on their cell surfaces. Sialic acid, a class of nine-carbon monosaccharides widely distributed on mammalian cell surfaces, participates in cell-cell recognition, immune regulation, and host-microbe interactions. Studies have shown that shed sialic acid from colorectal tumor cells enters the intestinal lumen, serving as a critical nutrient source for gut microbes. Notably, certain pathogens (e.g., Escherichia coli, Klebsiella pneumoniae) can utilize sialic acid as a carbon source to promote their proliferation and colonization. These pathogens may impair anastomotic healing through multiple mechanisms: first, by disrupting the intestinal mucosal barrier and exacerbating local inflammation; second, by inhibiting epithelial cell repair and delaying tissue regeneration; and third, by producing toxins or metabolites that further damage local tissues. Thus, colorectal tumor-derived sialic acid may indirectly increase the risk of postoperative anastomotic healing failure by nourishing specific pathogens.
Although existing research suggests that sialic acid from colorectal tumors influences the gut microenvironment by feeding pathogens, the specific mechanisms underlying its impact on postoperative anastomotic healing remain unclear. This hypothesis requires experimental validation. Our preliminary animal studies have demonstrated that oral administration of sialic acid impairs rectal anastomotic healing in mice by modulating gut microbiota. This finding indicates that sialic acid may affect postoperative anastomotic tissue repair and inflammatory responses by altering gut microbiota structure. However, research on the effects of sialic acid on the human gut microbiota remains limited. Based on this background, the present study aims to characterize the impact of sialic acid on gut microbiota by analyzing fecal samples collected from volunteers following oral sialic acid intervention.
Study Design： 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. Specifically, the control group specimens were fecal samples collected before oral sialic acid administration, while the experimental group specimens were fecal samples collected after oral sialic acid administration.
Primary Objective:Alterations in Gut Microbiota Structure
Key Outcomes： Data Analysis: Data extracted from electronic medical records. Statistical analysis using SPSS 22.0 (χ² test for categorical data, t-test for normally distributed continuous data; significance p<0.05).
Ethics: Approved by the institutional ethics committee. Conducted in accordance with the Declaration of Helsinki and Chinese regulations. Patient privacy and data confidentiality are prioritized.
Timeline: Patient data collection and analysis (Sep 2025-Aug 2026); Statistical analysis and manuscript preparation (Sep-Dec 2025).
Significance: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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| oral sialic acid | Experimental | Dietary Supplement: Oral Sialic acidThis 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Sialic acidThis 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 |
Primary outcome
Alterations in Gut Microbiota Structure
Time frame: From enrollment to the end of treatment at 2 weeks
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided. We are currently planning to conduct a series of studies. As data sharing will be postponed until all studies have been completed, the data will not be made available at this time.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Sialic acid in people with Taking Sialic Acid to Regulate the Gut Microbiota and Healthy, run by Xiaolong Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaolong Li, MD (+86 15025326575, 917304077@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alterations in Gut Microbiota Structure (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.