IgA NephropathyPro-IgANNCT06767592
A Study of Probiotics in IgA Nephropathy
A study testing Bio-Kult Advanced in people with IgA Nephropathy, run by University of Leicester at 1 site in United Kingdom.
Trial summary
IgA nephropathy (IgAN) occurs when a specific form of the IgA antibody lodges on the kidneys and causes damage, which may lead to kidney failure. This form of IgA is likely to come from the gut and the upper airways. Recent studies have shown that the bacteria that live in these areas may be different in IgAN. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Bio-Kult Advanced
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Oct 2023to 31 Dec 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven IgAN
- Age 18 years or older
- Able and willing to give informed consent
- Sufficient understanding of English to understand the patient information sheet and complete questionnaires
- No change in medications for 6 weeks up to the Baseline visit
- Stable diet (e.g. not a change to elimination, reduction, vegan or vegetarian diet) for 30-days prior to the baseline visit and during the study
Who cannot join
- Aged <18 years
- Unable or unwilling to give informed consent
- eGFR < 45 ml/min/1.73 m2 (measured by CKD-EPI formula)
- Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days
- Predicted to change diet during the study
- Any of the following conditions:
Show all 11Show fewer
- 6.1. Autoimmune disease (e.g. systemic lupus erythematosus) 6.2. Serious gastro-intestinal illness (including Crohn's disease, ulcerative colitis, chronic liver disease, significant gastrointestinal surgery or cancer, pancreatitis, motility disorder) 6.3. Diagnosed infectious illness within the previous 30-days
- Prescribed any of the following medication within the previous 60-days 7.1. Antibiotics or anti-viral medications 7.2. Steroids or other immunosuppressive agents
- Any other condition which in the opinion of the investigator could interfere with the study
- Enrolled in a clinical trial of an investigational medicinal product
- Allergy to any component of BioKult Advanced (including milk or soy allergy)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leicester General Hospital, University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE5 4PW
About this study
Official title: A Single-Arm Open-Label Feasibility Study of Probiotics for the Modulation of the Gut Microbiome in IgA Nephropathy (Pro-IgAN)
IgA nephropathy (IgAN) occurs when a specific form of the IgA antibody lodges on the kidneys and causes damage, which may lead to kidney failure. This form of IgA is likely to come from the gut and the upper airways.
Recent studies have shown that the bacteria that live in these areas may be different in IgAN. We think that the interaction between these and the immune system triggers production of the IgA that leads to kidney damage. We will examine these bacteria in detail, and test whether a probiotic can alter this favorably, and reduce harmful forms of IgA production in IgAN.
Read the detailed description
The purpose of this proposal is to conduct a proof of concept study, to test the hypothesis that dysbiosis of the gut microbiota plays a critical role in the development of IgAN.
Objectives are firstly, to characterise the gut microbiome, and faecal, plasma and urine metabolome, in relation to biomarkers of mucosal immunity and glomerular disease in patients with IgAN. Secondly, Investigators will test whether a multi-strain probiotic (Bio-Kult Advanced) produces a modulatory effect on these indices. The probiotic has been selected with our industry collaborator Protexin, based on previous studies demonstrating reduced faecal microbial diversity in patients with progressive IgAN, compared to those with non-progressive IgAN and healthy subjects.
This study will further our understanding of the interplay between the gut microbiome, metabolome, and mucosal immune system in IgAN. Investigators will generate important pilot data, to inform the design of a longer-term randomised clinical trial of probiotics in IgAN, and to identify potential plasma biomarkers to highlight those at risk of progressive disease, and those who may respond to treatments targeted to the gut.
- Conditions
- IgA Nephropathy
- Being tested
- Bio-Kult Advanced
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-Kult AdvancedDietary supplement
Bio-Kult Advanced will be provided as capsules and can be stored at room temperature. Participants will be instructed to swallow two capsules in the morning and two capsules in the evening, with food.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Participants will receive the multi-strain probiotic, Bio-Kult Advanced, 2 capsules twice daily between baseline and month 3 visits. Receives: Dietary Supplement: Bio-Kult Advanced |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in levels of IgA1 O-glycosylation at Month 3 compared to baseline.
The primary outcome, change in circulating IgA O-glycans levels between baseline and 3-months, will be analysed.
Measured: 3 months
Secondary outcomes (2)
Urine protein/creatinine ratio (UP/C) over a 6-month period
Change from baseline in proteinuria, measured by urinary protein/creatinine ratio [UPCR], up to Month 6
Measured: Up to Month 6
eGFR over a 6 month period
Rate of change in eGFR over a 6 month period from baseline
Measured: Up to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start13 Oct 2023
- Primary completion31 Aug 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- Kidney Cancer UK
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767592
- Sponsor's protocol ID
- 0718
- Acronym
- Pro-IgAN
- Status last verified
- May 2026
- First submitted
- 9 Oct 2023
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Open-Label Feasibility Study of Probiotics for the Modulation of the Gut Microbiome in IgA Nephropathy (Pro-IgAN)
- ClinicalTrials.gov ID
- NCT06767592
- Acronym / sponsor ID
- Pro-IgAN / 0718
- Conditions
- IgA Nephropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- Kidney Cancer UK
- Study start
- 13 Oct 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 10 Jan 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.
IgA nephropathy (IgAN) occurs when a specific form of the IgA antibody lodges on the kidneys and causes damage, which may lead to kidney failure. This form of IgA is likely to come from the gut and the upper airways.
Recent studies have shown that the bacteria that live in these areas may be different in IgAN. We think that the interaction between these and the immune system triggers production of the IgA that leads to kidney damage. We will examine these bacteria in detail, and test whether a probiotic can alter this favorably, and reduce harmful forms of IgA production in IgAN.
Detailed description
The purpose of this proposal is to conduct a proof of concept study, to test the hypothesis that dysbiosis of the gut microbiota plays a critical role in the development of IgAN.
Objectives are firstly, to characterise the gut microbiome, and faecal, plasma and urine metabolome, in relation to biomarkers of mucosal immunity and glomerular disease in patients with IgAN. Secondly, Investigators will test whether a multi-strain probiotic (Bio-Kult Advanced) produces a modulatory effect on these indices. The probiotic has been selected with our industry collaborator Protexin, based on previous studies demonstrating reduced faecal microbial diversity in patients with progressive IgAN, compared to those with non-progressive IgAN and healthy subjects.
This study will further our understanding of the interplay between the gut microbiome, metabolome, and mucosal immune system in IgAN. Investigators will generate important pilot data, to inform the design of a longer-term randomised clinical trial of probiotics in IgAN, and to identify potential plasma biomarkers to highlight those at risk of progressive disease, and those who may respond to treatments targeted to the gut.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: Bio-Kult AdvancedParticipants will receive the multi-strain probiotic, Bio-Kult Advanced, 2 capsules twice daily between baseline and month 3 visits. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Biopsy-proven IgAN
- Age 18 years or older
- Able and willing to give informed consent
- Sufficient understanding of English to understand the patient information sheet and complete questionnaires
- No change in medications for 6 weeks up to the Baseline visit
Key exclusion criteria (11 listed)
- Aged <18 years
- Unable or unwilling to give informed consent
- eGFR < 45 ml/min/1.73 m2 (measured by CKD-EPI formula)
- Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days
- Predicted to change diet during the study
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 |
|---|---|---|
| Bio-Kult AdvancedBio-Kult Advanced will be provided as capsules and can be stored at room temperature. Participants will be instructed to swallow two capsules in the morning and two capsules in the evening, with food. | Dietary supplement | Probiotic |
Primary outcome
Change in levels of IgA1 O-glycosylation at Month 3 compared to baseline.
Time frame: 3 months
The primary outcome, change in circulating IgA O-glycans levels between baseline and 3-months, will be analysed.
2 secondary outcomes
Urine protein/creatinine ratio (UP/C) over a 6-month period
Time frame: Up to Month 6
eGFR over a 6 month period
Time frame: Up to Month 6
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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 study testing Bio-Kult Advanced in people with IgA Nephropathy, run by University of Leicester at 1 site in United Kingdom.
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 6 inclusion and 11 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 3 Jun 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 United Kingdom. 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?
Change in levels of IgA1 O-glycosylation at Month 3 compared to baseline. (time frame: 3 months). 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 3 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.