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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site 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 | Olsztyn | Poland | Unknown status |
| Institute of Animal Reproduction and Food Research, Polish Academy of Sciences, ul. Tuwima 10 Coordinator of this site? Confirm its status | Olsztyn | Poland | Unknown status |
Related publications
- Effect of Inulin-Type Fructans on Body Composition, Carbohydrate Metabolism and Energy Expenditure in Patients with Psoriasis: Results of INGUTSKIN Randomized Controlled Trial.Nutrients · 2026 · PMID 42356231
- INulin-type β-fructans supplementation to modulate gut microbiota and assessment of its effects on health status and GUT-SKIN axis parameters in patients with psoriasis (INGUTSKIN): the 8-week, randomised, double-blind, placebo-controlled clinical study protocol.Nutr J · 2026 · PMID 41840402
This page is information, not medical advice. Discuss any trial with your doctor.