NCT04635670 (ProFOS) is a NA clinical trial of Pro-/prebiotic Mix in Type 1 Diabetes, sponsored by Steno Diabetes Center Copenhagen.

Who is sponsoring NCT04635670?

NCT04635670 is sponsored by Steno Diabetes Center Copenhagen.

What drugs are being tested in NCT04635670?

Interventions in NCT04635670: Pro-/prebiotic Mix, Placebo.

What condition does NCT04635670 study?

NCT04635670 studies Type 1 Diabetes, Nephropathy, Albuminuria, Diabetic Kidney Disease.

Is NCT04635670 still recruiting?

NCT04635670 is currently completed. Last updated 30 October 2023.

Last reviewed 2023-10-30 · How we verify

NCT04635670: ProFOS

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed NA Last updated 30 October 2023

What this trial tests

NA trial testing Pro-/prebiotic Mix in Type 1 Diabetes in 41 participants. Completed in 8 November 2022.

Timeline

29 June 2020

Primary endpoint
8 November 2022

8 November 2022

Quick facts

Lead sponsor	Steno Diabetes Center Copenhagen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	41
Start date	29 June 2020
Primary completion	8 November 2022
Estimated completion	8 November 2022
Sites	1 location across Denmark

Drugs / interventions tested

Pro-/prebiotic Mix
Placebo

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →
Nephropathy — all drugs for Nephropathy →
Albuminuria — all drugs for Albuminuria →
Diabetic Kidney Disease — all drugs for Diabetic Kidney Disease →

Sponsor

Steno Diabetes Center Copenhagen — full company profile →

Who can join

Adults 18 to 100, any sex, with Type 1 Diabetes or Nephropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Uremic Toxins in the Progression of Chronic Kidney Disease and Cardiovascular Disease: Mechanisms and Therapeutic Targets.
Lim YJ, Sidor NA, Tonial NC, Che A, et al · · 2021 · cited 227× · PMID 33668632 · DOI 10.3390/toxins13020142

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Steno Diabetes Center Copenhagen trials

Trials by the same sponsor.

NCT07485075 — Digital Support for Reducing Salt Intake Among Patients With Diabetic Kidney Disease: Protocol for a Controlled Clinical · NA · recruiting
NCT07427251 — The Postprandial Hypo-Avoid Study · Phase 4 · not yet recruiting
NCT06954090 — Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study · Phase 4 · enrolling by invitation
NCT06832059 — Precision Nutrition Versus Standard Dietary Care: Continuous Glucose Monitoring as a Tool for Guided Nutrition Care in T · NA · recruiting
NCT07377266 — The Impact of Changing to a New Child- and Family-centered Outpatient Diabetes Clinic Focusing on Early Involvement of t · NA · enrolling by invitation

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04635670 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Steno Diabetes Center Copenhagen
Last refreshed: 30 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04635670.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing