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NCT05971992Completed

INulin-type Fructans-induced Gut Microbiota Modulation Impact on GUT-SKIN Axis Parameters in Psoriasis

Effect of Intestinal Microbiota Modulation Induced by the Chicory Inulin-type β-fructans on Metabolic Parameters and Biomarkers of the Gut-skin Axis in Chronic Skin Inflammation

Source: ClinicalTrials.gov · Last updated 10 Jul 2025

Brief summary (registry, in English)

There is increasing evidence of a strong, bidirectional correlation between the gut and the skin, that associates gastrointestinal health with skin homeostasis and allostasis. The dysregulation in the intestinal microbiome-host interplay is connected with the development of many chronic skin inflammations. Plaque psoriasis is a chronic, immune-mediated non-communicable dermatitis affecting approximately 2-3% of the world's population, regardless of gender and age. In most cases (about 70-80%), the skin lesions are mild and do not require systemic treatment. Its etiology is not fully understood, but apart from the genetic predisposition, it is strongly associated with the "gut-skin axis". The rise of the local and systemic immune response in psoriasis is a consequence of systemic inflammation due to intestinal dysbiosis associated with increased intestinal permeability. Thus, gut microbiota modulation should become a research target due to its great potential to impact inflammation, including skin dermatitis, and its manifested consequences. Diet is an underestimated element in psoriasis management, meanwhile, the dietary ingredients support skin health. Among them, prebiotics favorably alters the composition and activity of the intestinal microbes and alleviates inflammation in the intestines. It was hypothesized that restoring the balance of the gut microbiome and the proper functioning of the intestinal barrier in subjects with psoriasis will alleviate the inflammatory symptoms and skin lesions observed in this chronic dermatitis. The goal of this clinical trial is to determine if a diet supplementation with prebiotic (chicory-derived inulin-type β-fructans; ITFs) vs. placebo (maltodextrin) will induce health-related benefits in a mild degree PS, and determine if the identified benefits are evoked by compositional and/or functional shifts of the intestinal bacterial communities. Healthy individuals will constitute a control group (C).

Status (registry)
Completed
Study type
Interventional
Enrollment
56 (actual)
First submitted
14 Jul 2023
Start date
Feb 2023
Primary completion date
Jun 2024
Lead sponsor
Polish Academy of Sciences
Diseases
Psoriasis
NCT number
NCT05971992

What you commit to

  • Study type: Interventional
  • Participants enrolled: 56
  • From Feb 2023 to the primary completion date, Jun 2024
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • positive tTG antibodies,
  • received antibiotics within previous month,
  • use of dietary supplements containing probiotic, prebiotic, and/or symbiotic within previous month,

Other illness

  • other chronic or acute inflammatory skin diseases,
  • gastrointestinal disease, cancer, cardiovascular complications, heart, kidney, and liver failure,

Other

  • bad or average overall health,
  • currently receive anti-psoriatic systemic and biologic treatment,
  • Pregnancy, lactation

Who the study is looking for

  • mild psoriasis (PASI \< 10),
  • omnivorous diet,
  • body mass index (BMI) 18 - 30 kg/m2
  • general good health
  • willing to give the written informed consent to participate the study

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, Municipal Hospital Complex, al. Wojska Polskiego 30
Coordinator of this site? Confirm its status
OlsztynPolandUnknown status
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences, ul. Tuwima 10
Coordinator of this site? Confirm its status
OlsztynPolandUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.