CompletedNot Applicable

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

Denmark41 participantsStarted 2020-06-29

Plain-language summary

The primary objective is to assess the impact of three months' treatment with pre-/probiotic mix on markers of nephropathy and other comorbidity related to diabetes. A double blinded, randomized, placebo-controlled crossover, single-centre study including 46 patients with type 1 diabetes and albuminuria. The treatment period is 2 x 12 weeks with 6 weeks washout. The primary outcome is to evaluate the effect of pre-/probiotic mix on albuminuria.

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

✓. 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)
✓. Albuminuria: UACR \> 30 mg/g (in ≥2 out 3 morning spot urine collections prior to randomization)
✓. Participants must be on stable renin-angiotensin system blocking treatment 4 weeks before start of study drug and throughout study duration.
✓. Able to understand the written participant information and give informed consent

What they're measuring

Change in albuminuria based on urinary albumin-creatinine ratio (UACR)

Timeframe: 30 weeks. Samples will be collected before and after each og te two treatment periods.

Trial details

NCT IDNCT04635670

SponsorSteno Diabetes Center Copenhagen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-08

View on ClinicalTrials.gov More Type 1 Diabetes trials