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

NCT04635670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2023-10-30

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Pro-/prebiotic Mix

Soluble powder for oral use of pre-/probiotic mix 3.0 g twice daily.

DIETARY_SUPPLEMENT

Placebo

Soluble powder for oral use twice daily.

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    collaborator INDUSTRY

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Peter Rossing, Proff, MD · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2022-11-08
Completion
2022-11-08

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04635670 on ClinicalTrials.gov