Probiotics in IgA Nephropathy

NCT ID: NCT01781312

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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IgA Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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ProTectis

Group Type EXPERIMENTAL

ProTectis

Intervention Type DIETARY_SUPPLEMENT

Gastrus

Group Type EXPERIMENTAL

Gastrus

Intervention Type DIETARY_SUPPLEMENT

Interventions

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ProTectis

Intervention Type DIETARY_SUPPLEMENT

Gastrus

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

Uppsala University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hilde Kloster Smerud

Clinical Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Linköping University Hospital

Linköping, , Sweden

Site Status

Karolinska University Hospital

Stockholm, , Sweden

Site Status

Uppsala University Hosptial

Uppsala, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Bengt Fellström, MD PhD

Role: CONTACT

Email: [email protected]

Hilde K Smerud, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Anders Fernström, MD PhD

Role: primary

Sigrid Lundberg, MD PhD

Role: primary

Bengt Fellström, MD PhD

Role: primary

Other Identifiers

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SMR-2712

Identifier Type: OTHER

Identifier Source: secondary_id

SMR-2712

Identifier Type: -

Identifier Source: org_study_id