Effects of Probiotics and Fibers on Albuminuria in Persons With Type 1 Diabetes

Plain-language summary

This study examines the effects of a probiotic and fiber mix compared with placebo in people with type 1 diabetes and protein leakage in the urine (albuminuria). It enrolled type 1 diabetes patients aged 18 and older with albuminuria who were on stable renin-angiotensin system blocking treatment. The study was conducted as a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

Steno Diabetes Center Copenhagen

Intervention

Pro-/prebiotic Mix, Placebo

Start date

6/29/2020

Estimated completion

11/8/2022

Countries

Denmark

Related genes

Locations

• Gentofte Municipality, Denmark

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Persons ≥ 18 years of age with a diagnosis of type 1 diabetes (age at onset \<40 years; permanent insulin treatment initiated within 1 year of diagnosis)
2. Albuminuria: UACR \> 30 mg/g (in ≥2 out 3 morning spot urine collections prior to randomization)
3. Participants must be on stable renin-angiotensin system blocking treatment 4 weeks before start of study drug and throughout study duration.
4. Able to understand the written participant information and give informed consent

Exclusion Criteria:

* 1\. Non-diabetic kidney disease indicated by medical history and/or laboratory findings 2. Known inflammatory bowel disease (IBD) 3. IBD symptoms due to investigator's opinion 4. Known celiac disease 5. Existing ostomy, malabsorption, history of bowel resection or bariatric surgery.

  6\. Heart valve replacement or history of endocarditis 7. Known rheumatic disorders treated with anti-inflammatory agents 8. Known hyperthyroidism or hypothyroidism 9. Active immunosuppressant therapy with systemic effect due to investigator's opinion 10. Current cancer treatment or within five years from baseline (except basal cell skin cancer or squamous cell skin cancer) 11. eGFR\<15 ml/min/1.73m2, dialysis or kidney transplantation 12. Active antibiotic therapy until 30 days ahead of screening 13. Dietary supplements containing fibers (e.g. psyllium), probiotics or carotenoids until 30 days ahead of screening 14. The receipt of any investigational product 90 days prior to this trial 15. Unable to participate in study procedures 16. Any clinically significant disorder, except for conditions associated with type 1 diabetes, which in the Investigators opinion could interfere with the results of the trial 17. Pregnancy or lactation 18. Participation in another intervention study