Gut MicrobiotaNCT04303286
The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
An observational study of Gut Microbiota and Hepatocellular Carcinoma, run by Tongji Hospital at 1 site in China.
Trial summary
The purpose of this study was to explore the correlation between postoperative recovery of liver function and gut microbiota in patients with hepatocellular carcinoma (HCC). Liver resection patients were divided into the recovery group and the recovery delay group according to the recovery level of liver function on… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota, Hepatocellular Carcinoma
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The cohort are the patients from the hepatic surgery of Tongji hospital.
Who may be able to join
- The patient is diagnosed with liver cancer by b-mode ultrasonography before the surgery.
- There is no antibiotic treatment, no severe diarrhea and regular diet within two weeks before the surgery.
- It perform laparoscopic or open hepatectomy.
- The postoperative pathological diagnosis is hepatocellular carcinoma.
Who cannot join
- No hepatectomy is performed during the operation.
- The patient is't hepatocellular carcinoma due to the postoperative pathological diagnosis.
- No stool samples are collected during the perioperative period.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study was to explore the correlation between postoperative recovery of liver function and gut microbiota in patients with hepatocellular carcinoma (HCC). Liver resection patients were divided into the recovery group and the recovery delay group according to the recovery level of liver function on the fifth day after the operation. Benign liver disease was used as a control. Statistical analysis was performed to compare the differences in gut microbiota between the three groups. Then, fecal microbiota transplantation was performed in a mouse hepatectomy model. Through this study, the investigators hope to understand the relationship between gut microbiota and postoperative recovery of liver function in patients with hepatocellular carcinoma, so as to provide a new therapeutic direction for patients in the aspect of perioperative liver function recovery.
Read the detailed description
Primary hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world. At present, surgery is the first choice and the most effective way to treat it. Based on the case review, the investigators found that the recovery rate of perioperative liver function was correlated with survival. Therefore, it is of great clinical significance to improve the recovery rate of postoperative liver function. Gut microbiota participate in many physiological activities of human body, such as metabolic regulation, immune homeostasis and hormone regulation. However, gut microbiota imbalance, excessive growth of pathogenic microorganisms and changes in intestinal mucosal permeability lead to intestinal bacterial ectopia and bacterial metabolites entering the liver through enterohepatic circulation. The continuous inflammatory stimulation aggravate the progress of liver disease. Therefore, it is helpful to explore the influence of gut microbiota on postoperative liver function recovery and find out the different microbiota, in order to improve the postoperative liver function recovery rate, shorten the perioperative hospital stay and prolong the survival of patients.
According to the recovery level of liver function on the fifth day after the operation, liver resection patients on HCC were divided into the recovery group and the recovery delay group which comparing on the time point of before the surgery and five days after the surgery. The patients on benign liver disease were used as a control. The investigators attempt to identify the differential microbiota and validate this finding in a mouse hepatectomy model.
- Conditions
- Gut Microbiota, Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recovery Group | The liver function of HCC patients on the fifth day after the operation is recovered. | |
| Recovery Delay Group | The liver function of HCC patients on the fifth day after the operation is delayed recovered. | |
| Control Group | The patients on benign disease of the liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diversity analysis
We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.
Measured: Before the surgery
Diversity analysis
We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.
Measured: Five days after the surgery
Species composition analysis
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample.
Measured: Before the surgery
Species composition analysis
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample.
Measured: Five days after the surgery
Species differential analysis
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.
Measured: Before the surgery
Species differential analysis
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.
Measured: Five days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Oct 2018
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gut MicrobiotaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Bi Xiang, MD, Tongji Hospital
- Investigators
- Bixiang Zhang, Study chair, Tongji HospitalJingjing Yu, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303286
- Sponsor's protocol ID
- TJ-IRB20191223
- Status last verified
- May 2022
- First submitted
- 5 Mar 2020
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu J, Zhu P, Shi L, Gao N, Li Y, Shu C, Xu Y, Yu Y, He J, Guo D, Zhang X, Wang X, Shao S, Dong W, Wang Y, Zhang W, Zhang W, Chen WH, Chen X, Liu Z, Yang X, Zhang B. Bifidobacterium longum promotes postoperative liver function recovery in patients with hepatocellular carcinoma. Cell Host Microbe. 2024 Jan 10;32(1):131-144.e6. doi: 10.1016/j.chom.2023.11.011. Epub 2023 Dec 12.
PubMed 38091982
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gut Microbiota on Postoperative Liver Function Recovery in Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04303286
- Acronym / sponsor ID
- TJ-IRB20191223
- Conditions
- Gut Microbiota, Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 11 Mar 2020 (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.
The purpose of this study was to explore the correlation between postoperative recovery of liver function and gut microbiota in patients with hepatocellular carcinoma (HCC). Liver resection patients were divided into the recovery group and the recovery delay group according to the recovery level of liver function on the fifth day after the operation. Benign liver disease was used as a control. Statistical analysis was performed to compare the differences in gut microbiota between the three groups. Then, fecal microbiota transplantation was performed in a mouse hepatectomy model. Through this study, the investigators hope to understand the relationship between gut microbiota and postoperative recovery of liver function in patients with hepatocellular carcinoma, so as to provide a new therapeutic direction for patients in the aspect of perioperative liver function recovery.
Detailed description
Primary hepatocellular carcinoma (HCC) is one of the most common malignant tumors in the world. At present, surgery is the first choice and the most effective way to treat it. Based on the case review, the investigators found that the recovery rate of perioperative liver function was correlated with survival. Therefore, it is of great clinical significance to improve the recovery rate of postoperative liver function. Gut microbiota participate in many physiological activities of human body, such as metabolic regulation, immune homeostasis and hormone regulation. However, gut microbiota imbalance, excessive growth of pathogenic microorganisms and changes in intestinal mucosal permeability lead to intestinal bacterial ectopia and bacterial metabolites entering the liver through enterohepatic circulation. The continuous inflammatory stimulation aggravate the progress of liver disease. Therefore, it is helpful to explore the influence of gut microbiota on postoperative liver function recovery and find out the different microbiota, in order to improve the postoperative liver function recovery rate, shorten the perioperative hospital stay and prolong the survival of patients.
According to the recovery level of liver function on the fifth day after the operation, liver resection patients on HCC were divided into the recovery group and the recovery delay group which comparing on the time point of before the surgery and five days after the surgery. The patients on benign liver disease were used as a control. The investigators attempt to identify the differential microbiota and validate this finding in a mouse hepatectomy model.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recovery Group | – | –The liver function of HCC patients on the fifth day after the operation is recovered. |
| Recovery Delay Group | – | –The liver function of HCC patients on the fifth day after the operation is delayed recovered. |
| Control Group | – | –The patients on benign disease of the liver |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The cohort are the patients from the hepatic surgery of Tongji hospital.
Key inclusion criteria (4 listed)
- The patient is diagnosed with liver cancer by b-mode ultrasonography before the surgery.
- There is no antibiotic treatment, no severe diarrhea and regular diet within two weeks before the surgery.
- It perform laparoscopic or open hepatectomy.
- The postoperative pathological diagnosis is hepatocellular carcinoma.
Key exclusion criteria (3 listed)
- No hepatectomy is performed during the operation.
- The patient is't hepatocellular carcinoma due to the postoperative pathological diagnosis.
- No stool samples are collected during the perioperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diversity analysis
Time frame: Before the surgery
We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.
Diversity analysis
Time frame: Five days after the surgery
We will use 16S rRNA sequencing to measure fecal sample. The alpha and beta diversity of gut microbiota between the groups will be analyzed, including a series of statistical analysis indexes such as Chao, Shannon, Simpsonace, Simpson and Coverage, in order to reflect the microbial community diversity.
Species composition analysis
Time frame: Before the surgery
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample.
Species composition analysis
Time frame: Five days after the surgery
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the community histogram, the community heatmap and the Wayne map will be used to analyze the species composition of the sample, in order to explore the relationship between the species and the sample, and analyze the key microflora in the sample.
Species differential analysis
Time frame: Before the surgery
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.
Species differential analysis
Time frame: Five days after the surgery
We will use 16S rRNA sequencing to measure fecal sample. Based on the results of species annotation, the PCA、PCoA and NMDS analysis will be used to assess the similarities and differences in species composition between groups. To further screen the species with significant differences, the LEfSe difference discriminant analysis will be used.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 38091982Yu J, Zhu P, Shi L, Gao N, Li Y, Shu C, Xu Y, Yu Y, He J, Guo D, Zhang X, Wang X, Shao S, Dong W, Wang Y, Zhang W, Zhang W, Chen WH, Chen X, Liu Z, Yang X, Zhang B. Bifidobacterium longum promotes postoperative liver function recovery in patients with hepatocellular carcinoma. Cell Host Microbe. 2024 Jan 10;32(1):131-144.e6. doi: 10.1016/j.chom.2023.11.011. Epub 2023 Dec 12.
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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. This study is not recruiting at the moment.
Bixiang Zhang study chair
Tongji Hospital
Jingjing Yu principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gut Microbiota and Hepatocellular Carcinoma, run by Tongji Hospital 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 3 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: finished, as of the sponsor's last update on 12 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diversity analysis (time frame: Before the surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303286, which also lists 1 linked publication.
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 12 May 2022.