Cirrhosis, LiverPhase 4NCT05687409
Synbiotics Interventions for Managing Cirrhosis and Its Complications
A Phase 4 study testing Entecavir 0.5 mg, A 10-g packet of lactulose oral solution and three capsules of probiotics and A 10-g packet of glucose oral solution and three capsules of starch in people with Cirrhosis, Liver and Metagonimiasis, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Liver, Metagonimiasis
- What is being tested?
- Entecavir 0.5 mg, A 10-g packet of lactulose oral solution and three capsules of probiotics and A 10-g packet of glucose oral solution and three capsules of starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2019to 24 Oct 2022
- Phase
- Phase 4
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ① Hepatitis B cirrhosis was diagnosed by clinical biochemistry and imaging.
- CTP rating is a-b.
- There was a previous liver cirrhosis complication, including ascites, spontaneous peritonitis, massive gastrointestinal bleeding, liver coma, etc.
- Over 18 years old. ⑤ Under 90 years old.
- The patient or family member signs the informed consent form.
Who cannot join
- ① The CTP of liver cirrhosis was evaluated as grade C.
- Other types of cirrhosis such as primary biliary cirrhosis.
- Pregnancy status. ④ Have a history of diabetes, renal insufficiency, gastrointestinal surgery, etc.
- Antibiotics, PPI preparations and microecological preparations (including yogurt) have been used in the past 8 weeks.
- Have a history of narcotic drug abuse, drug abuse, or mental illness. ⑦ Patients and their families do not agree to sign the informed consent form. ⑧ Under 18 years old or over 90 years old.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang
About this study
Official title: Alterations in the Intestinal Microbiome and Metabolic Profile of Patients With Cirrhosis Supplemented With Lactulose, Clostridium Butyricum, and Bifidobacterium Longum Infantis: a Randomized Placebo-controlled Trial
Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.
Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.
- Conditions
- Cirrhosis, Liver, Metagonimiasis
- Being tested
- Entecavir 0.5 mg, A 10-g packet of lactulose oral solution and three capsules of probiotics, A 10-g packet of glucose oral solution and three capsules of starch
- Keywords
- Cirrhosis, Liver, Synbiotics
- Medical subject headings
- Liver Cirrhosis, Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entecavir 0.5 mgDrug
Orally administered Entecavir 0.5 mg, once a day. For six months
A 10-g packet of lactulose oral solution and three capsules of probioticsDrug
A 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis).
Participants orally administered the contents three times daily after meals. For six months.
A 10-g packet of glucose oral solution and three capsules of starchDietary supplement
A 10-g packet of glucose oral solution and three capsules of starch. Participants orally administered the contents three times daily after meals. For six months.
| Study group | Role | What they receive |
|---|---|---|
| A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group | Experimental | 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals.
Entecavir 5mg, once a day. All of the above lasted for six months. Receives: Drug: Entecavir 0.5 mg; Drug: A 10-g packet of lactulose oral solution and three capsules of probiotics |
| A 10-g packet of glucose oral solution and three capsules of starch+entecavir group | Placebo comparator | A 10-g packet of glucose oral solution and three capsules of starch+entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals.
Entecavir 5mg, once a day. All of the above lasted for six months. Receives: Drug: Entecavir 0.5 mg; Dietary Supplement: A 10-g packet of glucose oral solution and three capsules of starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver CT to assess cirrhosis in 70 cirrhotic participants
Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants
Measured: Up to 11 months
Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
fecal metagenomics was used to assess the intestinal microbiota of participants.
Measured: Up to 12 months
Metabolomics to assess the metabolites of the 120 cirrhotic and healthy participants' intestinal microbiota including polyketides(Casimiroedine μmol/L),Benzenoids(Olmesartan μmol/L),Organoheterocyclic compounds(Amlexanox μmol/L) and etc.
Metabolomics was used to assess the metabolites of the participants' intestinal microbiota.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start24 Nov 2019
- Primary completion24 May 2021
- Study completion24 Oct 2022
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 Cirrhosis, LiverStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687409
- Sponsor's protocol ID
- wuzhongwenzju
- Status last verified
- Nov 2022
- First submitted
- 25 Nov 2022
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: share date: within 6 months after project finish. Website: Resman. http://www.medresman.org.cn/pub/cn/proj/search.aspx
Publications
Lu H, Zhu X, Wu L, Lou X, Pan X, Liu B, Zhang H, Zhu L, Li L, Wu Z. Alterations in the intestinal microbiome and metabolic profile of patients with cirrhosis supplemented with lactulose, Clostridium butyricum, and Bifidobacterium longum infantis: a randomized placebo-controlled trial. Front Microbiol. 2023 Apr 26;14:1169811. doi: 10.3389/fmicb.2023.1169811. eCollection 2023.
PubMed 37180228
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in the Intestinal Microbiome and Metabolic Profile of Patients With Cirrhosis Supplemented With Lactulose, Clostridium Butyricum, and Bifidobacterium Longum Infantis: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05687409
- Acronym / sponsor ID
- wuzhongwenzju
- Conditions
- Cirrhosis, Liver, Metagonimiasis
- Keywords
- Cirrhosis, Liver, Synbiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 24 Nov 2019 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 24 Oct 2022 (actual)
- First posted
- 18 Jan 2023 (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.
Background Liver cirrhosis is commonly accompanied by intestinal dysbiosis and metabolic defects. Many clinical trials have shown microbiota-targeting strategies represent promising interventions for managing cirrhosis and its complications. However, the influences of the intestinal metagenomes and metabolic profiles of patients have not been fully elucidated.
Methods administered lactulose, Clostridium butyricum, and Bifidobacterium longum infantis as a synbiotic and used shotgun metagenomics and non-targeted metabolomics to characterize the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group | Experimental | Drug: Entecavir 0.5 mg, Drug: A 10-g packet of lactulose oral solution and three capsules of probiotics10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals. Entecavir 5mg, once a day. All of the above lasted for six months. |
| A 10-g packet of glucose oral solution and three capsules of starch+entecavir group | Placebo comparator | Drug: Entecavir 0.5 mg, Dietary Supplement: A 10-g packet of glucose oral solution and three capsules of starchA 10-g packet of glucose oral solution and three capsules of starch+entecavir group:Adults with histologically confirmed stable cirrhosis and BMI < 25 kg m-2 were enrolled and assigned to receive boxes labeled A or B: one for the synbiotic, including a 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals. Entecavir 5mg, once a day. All of the above lasted for six months. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ① Hepatitis B cirrhosis was diagnosed by clinical biochemistry and imaging.
Key exclusion criteria (5 listed)
- ① The CTP of liver cirrhosis was evaluated as grade C.
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 |
|---|---|---|
| Entecavir 0.5 mgOrally administered Entecavir 0.5 mg, once a day. For six months | Drug | A 10-g packet of glucose oral solution and three capsules of starch+entecavir group, A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group |
| A 10-g packet of lactulose oral solution and three capsules of probioticsA 10-g packet of lactulose oral solution and three capsules of probiotics (each containing > 4.2×106 CFU Clostridium butyricum and > 4.2×105 CFU Bifidobacterium longum infantis). Participants orally administered the contents three times daily after meals. For six months. | Drug | A 10-g packet of lactulose oral solution and three capsules of probiotics +entecavir group |
| A 10-g packet of glucose oral solution and three capsules of starchA 10-g packet of glucose oral solution and three capsules of starch. Participants orally administered the contents three times daily after meals. For six months. | Dietary supplement | A 10-g packet of glucose oral solution and three capsules of starch+entecavir group |
Primary outcome
Liver CT to assess cirrhosis in 70 cirrhotic participants
Time frame: Up to 11 months
Liver CT was used to evaluate the liver cirrhosis of 70 cirrhotic participants
Assessing the intestinal microbiota of 120 cirrhotic and healthy participants through fecal metagenomics
Time frame: Up to 12 months
fecal metagenomics was used to assess the intestinal microbiota of participants.
Metabolomics to assess the metabolites of the 120 cirrhotic and healthy participants' intestinal microbiota including polyketides(Casimiroedine μmol/L),Benzenoids(Olmesartan μmol/L),Organoheterocyclic compounds(Amlexanox μmol/L) and etc.
Time frame: Up to 12 months
Metabolomics was used to assess the metabolites of the participants' intestinal microbiota.
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 18 Jan 2023.
- Derived from this study: PubMed 37180228Lu H, Zhu X, Wu L, Lou X, Pan X, Liu B, Zhang H, Zhu L, Li L, Wu Z. Alterations in the intestinal microbiome and metabolic profile of patients with cirrhosis supplemented with lactulose, Clostridium butyricum, and Bifidobacterium longum infantis: a randomized placebo-controlled trial. Front Microbiol. 2023 Apr 26;14:1169811. doi: 10.3389/fmicb.2023.1169811. eCollection 2023.
- Individual participant dataSharing planned: Undecided. share date: within 6 months after project finish. Website: Resman. http://www.medresman.org.cn/pub/cn/proj/search.aspx
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entecavir 0.5 mg, A 10-g packet of lactulose oral solution and three capsules of probiotics and A 10-g packet of glucose oral solution and three capsules of starch in people with Cirrhosis, Liver and Metagonimiasis, run by First Affiliated Hospital of Zhejiang University 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 5 inclusion and 5 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 18 Jan 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Liver CT to assess cirrhosis in 70 cirrhotic participants (time frame: Up to 11 months). The study lists 3 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 NCT05687409, 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 18 Jan 2023.