IgA NephropathyNCT01781312
Probiotics in IgA Nephropathy
A study testing ProTectis and Gastrus in people with IgA Nephropathy, run by Uppsala University Hospital at 3 sites in Sweden.
Trial summary
Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. 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?
- ProTectis and Gastrus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSweden
- Study dates
- Jan 2013to Aug 2014
- 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
- Above 18 years
- Primary IgAN, verified by biopsy
- Albuminuria > 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion)
- Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion)
- Having signed informed consent form
Who cannot join
- Participation in another clinical intervention trial
- Patients with celiac disease
- Patients with secondary IgAN
- Creatinine clearance below 30 ml/min (mean of 3 measurements)
- Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion
- Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
- Patients using probiotic products within the last three months (includes probiotic milk products)
- Known allergy or intolerance to any of the ingredients in the probiotic product
Trial locations and contacts
3 sites in 1 country.
Bengt Fellström, MD PhD contact
Hilde K Smerud, PhD contact
Sweden3 sites
Linköping University Hospital
Linköping
Anders Fernström, MD PhD
Anders Fernström, MD PhD
Karolinska University Hospital
Stockholm
Sigrid Lundberg, MD PhD
Sigrid Lundberg, MD PhD
Uppsala University Hosptial
Uppsala
Bengt Fellström, MD PhD
Bengt Fellström, MD PhD
About this study
Official title: Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.
- Conditions
- IgA Nephropathy
- Being tested
- ProTectis, Gastrus
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTectisDietary supplement
GastrusDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| ProTectis | Experimental | Not described Receives: Dietary Supplement: ProTectis |
| Gastrus | Experimental | Not described Receives: Dietary Supplement: Gastrus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in albuminuria
Measured: Baseline and 3 months
Secondary outcomes (5)
Change in renal function
Measured: Baseline and 3 months
Change in IgA/IgG immune complexes
Measured: Baseline and 3 months
Change in hematuria
Measured: Baseline and 3 months
Change in immunological markers in blood
Measured: Baseline and 3 months
Change in IBS (irritable bowel syndrome) symptoms
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionJul 2014 (estimated)
- Study completionAug 2014 (estimated)
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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Karolinska Institutet
- Responsible party
- Principal investigator, Hilde Kloster Smerud, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781312
- Sponsor's protocol ID
- SMR-2712
- Other IDs
- SMR-2712
- Status last verified
- Jan 2013
- First submitted
- 16 Jan 2013
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
- ClinicalTrials.gov ID
- NCT01781312
- Acronym / sponsor ID
- SMR-2712
- Conditions
- IgA Nephropathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Karolinska Institutet
- Study start
- Jan 2013
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 31 Jan 2013 (estimated)
- 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.
Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProTectis | Experimental | Dietary Supplement: ProTectis |
| Gastrus | Experimental | Dietary Supplement: Gastrus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above 18 years
- Primary IgAN, verified by biopsy
- Albuminuria > 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion)
- Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion)
- Having signed informed consent form
Key exclusion criteria (8 listed)
- Participation in another clinical intervention trial
- Patients with celiac disease
- Patients with secondary IgAN
- Creatinine clearance below 30 ml/min (mean of 3 measurements)
- Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion
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 |
|---|---|---|
| ProTectis | Dietary supplement | ProTectis |
| Gastrus | Dietary supplement | Gastrus |
Primary outcome
Change in albuminuria
Time frame: Baseline and 3 months
5 secondary outcomes
Change in renal function
Time frame: Baseline and 3 months
Change in IgA/IgG immune complexes
Time frame: Baseline and 3 months
Change in hematuria
Time frame: Baseline and 3 months
Change in immunological markers in blood
Time frame: Baseline and 3 months
Change in IBS (irritable bowel syndrome) symptoms
Time frame: Baseline and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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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.
Bengt Fellström, MD PhD contact
Hilde K Smerud, PhD contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProTectis and Gastrus in people with IgA Nephropathy, run by Uppsala University Hospital at 3 sites in Sweden.
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 8 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: status not confirmed, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bengt Fellström, MD PhD (bengt.fellstrom@medsci.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in albuminuria (time frame: Baseline and 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 31 Jan 2013.