SymbioticNCT07461233
Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients
A study testing Multispecies Synbiotic Supplementation in people with Symbiotic and Uremic Toxins, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
Trial summary
Chronic kidney disease (CKD) patients undergoing maintenance hemodialysis experience profound alterations in their gut microbiota, leading to dysbiosis and increased gut permeability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symbiotic, Uremic Toxins, Gut -Microbiota
- What is being tested?
- Multispecies Synbiotic Supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2026to 31 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
Who cannot join
- Use of probiotic supplements within the last month;
- Hospitalization within the past month for acute infections or CKD-related complications;
- History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
- Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
- Use of antibiotics or immunosuppressive therapy within the preceding three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tungs' Taichung Metroharbour Hospital
Taichung, Wuqi District, 435
Paik Seong Lim, PhD, +886935045292, jamespslim@gmail.com
About this study
Chronic kidney disease (CKD) patients undergoing maintenance hemodialysis experience profound alterations in their gut microbiota, leading to dysbiosis and increased gut permeability. This disruption facilitates the translocation of endotoxins and gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate into the systemic circulation, contributing to heightened systemic inflammation, cardiovascular disease risk, and accelerated CKD progression.
Synbiotic supplementation, particularly multispecies formulations, has emerged as a promising therapeutic strategy to restore gut microbial balance, enhance intestinal barrier integrity, and reduce the systemic burden of deleterious microbial metabolites. These probiotics potentially improve clinical outcomes by modulating inflammatory pathways and decreasing circulating levels of uremic toxins.
Despite these insights, few clinical trials have comprehensively assessed the effects of multispecies synbiotic on fecal microbiome composition, gut permeability and uremic toxin profiles in hemodialysis patients. This pilot study aims to fill this gap by evaluating the modulatory effects of a 12-week multispecies synbiotic intervention.
Read the detailed description
Study Design and Objectives
This investigation is a single-arm, open-label pilot trial designed to assess the impact of a multispecies synbiotic supplementation on gut-derived uremic toxins and fecal microbiota composition over 12 weeks in adults with in a group of hemodialysis patients.
The primary objectives are to:
- Evaluate changes in fecal microbiomes,
- Assess the serum levels of uremic toxins and gut permeability markers
Study Population
- Inclusion criteria: Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
- Exclusion criteria:
- Use of probiotic supplements within the last month;
- Hospitalization within the past month for acute infections or CKD-related complications;
- History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
- Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
- Use of antibiotics or immunosuppressive therapy within the preceding three months.
Sample Size Justification This pilot study targets 30 participants, which provides adequate power (80%, alpha 0.05) to detect a medium effect size (Cohen's d = 0.6) on the primary outcome, serum indoxyl sulfate levels. Calculations based on expected changes from 8.0 mg/L to 6.5 mg/L with SD of 2.5 mg/L indicate a required sample size of ~24; the sample size accounts for potential dropouts to ensure study robustness.
Study Procedures
- Baseline assessments:
- Measurement of serum and urine uremic toxins,
- Measurement of gut permeability markers
- Fecal microbiome analysis
- Intervention:
Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358 with additional prebiotics
- Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water.
- Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.
- Follow-up and Monitoring:
- At 4 weeks: Monitoring and documentation of gastrointestinal symptoms and adverse events.
- At 12 weeks: Repeat evaluations identical to baseline, including blood and urine tests.
Compliance and Safety
- Adherence will be tracked via regular follow-up contacts.
- An adherence rate of 80-100% is considered acceptable.
- All adverse drug reactions and any unexpected events will be recorded throughout the study duration.
Biological Sample Collection and Laboratory Methods
- Blood Sampling:
- Fasting blood samples will be collected following an 8-hour fast.
- Samples will be centrifuged at 3,000 rpm for 10 minutes within 1 hour post-collection.
- Serum aliquots (200 μL) will be stored at -80°C until batch analysis.
- Intestinal permeability markers: Intestinal fatty acid-binding protein (I-FABP), diamine oxidase (DAO),and zonulin (human)
- Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indole acetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography (HPLC) according to established protocols.
- Fecal microbiome analysis
Ethical Considerations
- Written informed consent will be obtained from all participants before enrollment.
- The study will be conducted in compliance with Taiwanese Good Clinical Practice (GCP) guidelines, local regulatory requirements, and the Declaration of Helsinki.
- Ethical approval has been granted by the Institutional Review Board of Tungs' Taichung MetroHarbour Hospital.
- Conditions
- Symbiotic, Uremic Toxins, Gut -Microbiota, Gut Permeability, Hemodialysis
- Being tested
- Multispecies Synbiotic Supplementation
- Keywords
- multispecies synbiotic, hemodialysis patients, uremic toxins, gut microbiome, gut permeability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispecies Synbiotic SupplementationDietary supplement
Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. • Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. • Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.
| Study group | Role | What they receive |
|---|---|---|
| Multispecies synbiotic | Experimental | Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. • Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. • Storage: Capsules to be kept below 25°C, in a dry, light-protected environment. Receives: Dietary Supplement: Multispecies Synbiotic Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate changes in fecal microbiomes
This study employed whole genome sequencing (WGS) for fecal microbial analysis.Alpha diversity is estimated by species richness using the Chao1 index at the OTU level. A rarefaction curve is generated by randomly selecting a subset of sequencing data from each sample to represent the number of observed species, and a species accumulation curve is plotted to show the occurrence of new OTUs (species) with continuous sampling. For beta diversity, Bray-Curtis dissimilarities at the OTU level are calculated and analyzed using the vegan package.
Differential abundance analysis was performed using statistical methods appropriate for compositional microbiome and functional gene data (such as LEfSe, ANCOM-BC, ALDEx2, MaAsLin2, or DESeq2). Multiple hypothesis testing was adjusted using the Benjamini-Hochberg false discovery rate (FDR) correction.
Measured: 1 years
Assess the serum levels of uremic toxins
Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indole acetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography (HPLC) according to established protocols.
Measured: 1 years
Assess the serum levels of and gut permeability markers
Quantification of gut permeability markers, such as intestinal fatty acid-binding protein (I-FABP), diamine oxidase (DAO), and zonulin concentrations, using validated ELISA kits.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start4 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SymbioticStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tungs' Taichung Metroharbour Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paik Seong Lim, PhD, Study chair, Tungs' Taichung Metroharbour Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461233
- Sponsor's protocol ID
- 114109
- Other IDs
- TTMHH-R1150028
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Gut Microbiota Composition and Gut Permeability Profiles by Multispecies Synbiotic Supplementation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT07461233
- Acronym / sponsor ID
- 114109
- Conditions
- Symbiotic, Uremic Toxins, Gut -Microbiota, Gut Permeability, Hemodialysis
- Keywords
- multispecies synbiotic, hemodialysis patients, uremic toxins, gut microbiome, gut permeability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tungs' Taichung Metroharbour HospitalUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
Chronic kidney disease (CKD) patients undergoing maintenance hemodialysis experience profound alterations in their gut microbiota, leading to dysbiosis and increased gut permeability. This disruption facilitates the translocation of endotoxins and gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate into the systemic circulation, contributing to heightened systemic inflammation, cardiovascular disease risk, and accelerated CKD progression.
Synbiotic supplementation, particularly multispecies formulations, has emerged as a promising therapeutic strategy to restore gut microbial balance, enhance intestinal barrier integrity, and reduce the systemic burden of deleterious microbial metabolites. These probiotics potentially improve clinical outcomes by modulating inflammatory pathways and decreasing circulating levels of uremic toxins.
Despite these insights, few clinical trials have comprehensively assessed the effects of multispecies synbiotic on fecal microbiome composition, gut permeability and uremic toxin profiles in hemodialysis patients. This pilot study aims to fill this gap by evaluating the modulatory effects of a 12-week multispecies synbiotic intervention.
Detailed description
Study Design and Objectives
This investigation is a single-arm, open-label pilot trial designed to assess the impact of a multispecies synbiotic supplementation on gut-derived uremic toxins and fecal microbiota composition over 12 weeks in adults with in a group of hemodialysis patients.
The primary objectives are to:
- Evaluate changes in fecal microbiomes,
- Assess the serum levels of uremic toxins and gut permeability markers
Study Population
- Inclusion criteria: Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
- Exclusion criteria:
- Use of probiotic supplements within the last month;
- Hospitalization within the past month for acute infections or CKD-related complications;
- History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
- Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
- Use of antibiotics or immunosuppressive therapy within the preceding three months.
Sample Size Justification This pilot study targets 30 participants, which provides adequate power (80%, alpha 0.05) to detect a medium effect size (Cohen's d = 0.6) on the primary outcome, serum indoxyl sulfate levels. Calculations based on expected changes from 8.0 mg/L to 6.5 mg/L with SD of 2.5 mg/L indicate a required sample size of ~24; the sample size accounts for potential dropouts to ensure study robustness.
Study Procedures
- Baseline assessments:
- Measurement of serum and urine uremic toxins,
- Measurement of gut permeability markers
- Fecal microbiome analysis
- Intervention:
Participants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358 with additional prebiotics
- Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water.
- Storage: Capsules to be kept below 25°C, in a dry, light-protected environment.
- Follow-up and Monitoring:
- At 4 weeks: Monitoring and documentation of gastrointestinal symptoms and adverse events.
- At 12 weeks: Repeat evaluations identical to baseline, including blood and urine tests.
Compliance and Safety
- Adherence will be tracked via regular follow-up contacts.
- An adherence rate of 80-100% is considered acceptable.
- All adverse drug reactions and any unexpected events will be recorded throughout the study duration.
Biological Sample Collection and Laboratory Methods
- Blood Sampling:
- Fasting blood samples will be collected following an 8-hour fast.
- Samples will be centrifuged at 3,000 rpm for 10 minutes within 1 hour post-collection.
- Serum aliquots (200 μL) will be stored at -80°C until batch analysis.
- Intestinal permeability markers: Intestinal fatty acid-binding protein (I-FABP), diamine oxidase (DAO),and zonulin (human)
- Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indole acetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography (HPLC) according to established protocols.
- Fecal microbiome analysis
Ethical Considerations
- Written informed consent will be obtained from all participants before enrollment.
- The study will be conducted in compliance with Taiwanese Good Clinical Practice (GCP) guidelines, local regulatory requirements, and the Declaration of Helsinki.
- Ethical approval has been granted by the Institutional Review Board of Tungs' Taichung MetroHarbour Hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multispecies synbiotic | Experimental | Dietary Supplement: Multispecies Synbiotic SupplementationParticipants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. • Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. • Storage: Capsules to be kept below 25°C, in a dry, light-protected environment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18 years or older receiving maintenance hemodialysis patients for at least 3 months
Key exclusion criteria (5 listed)
- Use of probiotic supplements within the last month;
- Hospitalization within the past month for acute infections or CKD-related complications;
- History of major intestinal surgeries (gastrectomy, cholecystectomy; appendectomy allowed);
- Presence of viral hepatitis, liver cirrhosis, active malignancy, advanced congestive heart failure, or thyroid disorders;
- Use of antibiotics or immunosuppressive therapy within the preceding three months.
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 |
|---|---|---|
| Multispecies Synbiotic SupplementationParticipants will receive Renobiome multispecies synbiotic containing 30 billion CFUs per capsule, including strains of Lactobacillus rhamnosus (strain ID pending), Lactobacillus salivarius LS 159, Lactobacillus pentosus LPE 588, and Lactococcus lactis LL 358. • Dose: One capsule twice daily (morning and evening), with or without food, taken with room-temperature water. • Storage: Capsules to be kept below 25°C, in a dry, light-protected environment. | Dietary supplement | Multispecies synbiotic |
Primary outcome
Evaluate changes in fecal microbiomes
Time frame: 1 years
This study employed whole genome sequencing (WGS) for fecal microbial analysis.Alpha diversity is estimated by species richness using the Chao1 index at the OTU level. A rarefaction curve is generated by randomly selecting a subset of sequencing data from each sample to represent the number of observed species, and a species accumulation curve is plotted to show the occurrence of new OTUs (species) with continuous sampling. For beta diversity, Bray-Curtis dissimilarities at the OTU level are calculated and analyzed using the vegan package. Differential abundance analysis was performed using statistical methods appropriate for compositional microbiome and functional gene data (such as LEfSe, ANCOM-BC, ALDEx2, MaAsLin2, or DESeq2). Multiple hypothesis testing was adjusted using the Benjamini-Hochberg false discovery rate (FDR) correction.
Assess the serum levels of uremic toxins
Time frame: 1 years
Concentrations of indoxyl sulfate (IS), p-cresyl sulfate (PCS), indole acetic acid (IAA), and indolelactic acid (ILA) in serum and urine will be determined by high-performance liquid chromatography (HPLC) according to established protocols.
Assess the serum levels of and gut permeability markers
Time frame: 1 years
Quantification of gut permeability markers, such as intestinal fatty acid-binding protein (I-FABP), diamine oxidase (DAO), and zonulin concentrations, using validated ELISA kits.
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 25 Sep 2026.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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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.
Paik Seong Lim, PhD study chair
Tungs' Taichung Metroharbour Hospita
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispecies Synbiotic Supplementation in people with Symbiotic and Uremic Toxins, run by Tungs' Taichung Metroharbour Hospital at 1 site in Taiwan.
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 1 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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 Taiwan. 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 Paik Seong Lim, PhD (+886935045292, jamespslim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate changes in fecal microbiomes (time frame: 1 years). 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?
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 25 Sep 2026.