PsoriasisINGUTSKINNCT05971992
INulin-type Fructans-induced Gut Microbiota Modulation Impact on GUT-SKIN Axis Parameters in Psoriasis
A study testing Chicory-derived inulin-type β-fructans and Maltodextrin in people with Psoriasis, run by Polish Academy of Sciences at 2 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis
- What is being tested?
- Chicory-derived inulin-type β-fructans and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 2 sitesPoland
- Study dates
- 2 Feb 2023to 28 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other chronic or acute inflammatory skin diseases,
- gastrointestinal disease, cancer, cardiovascular complications, heart, kidney, and liver failure,
- bad or average overall health,
- positive tTG antibodies,
- currently receive anti-psoriatic systemic and biologic treatment,
- received antibiotics within previous month,
- use of dietary supplements containing probiotic, prebiotic, and/or symbiotic within previous month,
- Pregnancy, lactation
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, Municipal Hospital Complex, al. Wojska Polskiego 30
Olsztyn, 10-229
Institute of Animal Reproduction and Food Research, Polish Academy of Sciences, ul. Tuwima 10
Olsztyn, 10-748
About this study
Official title: 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
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.
Read more
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).
Read the detailed description
The gut microbiota contributes to the health of the host. It enables the digestion of food, the proper functioning of the immune system, and protection against the invasion of pathogens. The gut microorganisms play a key role in maintaining the integrity of the intestinal epithelium. The epithelium serves as a selective barrier that, on the one hand, separates the immune cells of the intestinal mucosa from the microorganisms present in the lumen of the gut, and at the same time allows microbial metabolites to interact with the host cells and thus regulate the immune response. Dysbiosis of the intestinal microflora may result in damage to the intestinal integrity and, consequently, an increase in the permeability of the intestinal barrier. The translocation of bacterial antigens and metabolites into the bloodstream contributes to the activation of the local and systemic immune response resulting in local and systemic inflammation. Disruption of the interaction between the gut microbiome and the host can lead to inflammation. Plaque psoriasis is a chronic, immune-mediated dermatitis. It is manifested by peeling, itching, and reddening of the skin. Psoriasis is a non-communicable disease 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. The etiology of psoriasis development is not fully understood. In addition to genetic predisposition, the increased immune response in PS may be a consequence of systemic inflammation due to intestinal dysbiosis associated with increased intestinal permeability.
Dietary ingredients support skin health. Among them, prebiotics gained our special interest as ingredients with proven beneficial effects on host health by modulating gut microflora. Inulin-type fructans derived from chicory are prebiotics that favorably alters the composition and activity of the intestinal microbes and alleviates the inflammation in the intestines. The investigators supposed that restoring the balance of the gut microbiota 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 aim of the research is to determine whether dietary supplementation with inulin-type β-fructans derived from chicory will transfer health benefits to individuals with psoriasis and to investigate whether these benefits are due to modification of the composition or activity of the gut microbiota.
To achieve this goal, the original, advanced, and complex studies were proposed on subjects with psoriasis to investigate the effects of dietary inulin-type fructans on the characteristics of the gut microflora, metabolic parameters, and biomarkers of the skin-gut axis. The obtained results will provide new knowledge and explain the nature of the interaction between the gut microbiota and the skin, providing further clues about the functioning of the gut-skin axis.
- Conditions
- Psoriasis
- Being tested
- Chicory-derived inulin-type β-fructans, Maltodextrin
- Keywords
- prebiotics, inulin-type fructans, chronic skin inflammation, inflammatory mediators and cytokines, intestinal barrier permeability, Psoriasis Area and Severity Index, dysbiosis, metabolic dysregulation, nutritional status, anthropometric indices, indirect respirometry, functional multi-sugars absorption test, quality of life, characteristics of gut microbiota, short-chain fatty acids, immunohistological skin analysis, gene expression, oxidative stress, volatile organic compounds
- Medical subject headings
- Psoriasis, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chicory-derived inulin-type β-fructansDietary supplement
Also called Orafti®Synergy1 (Beneo, Tienen, Belgium)
This supplement will be portioned into moisture-impermeable sachets containing 7.5 grams of prebiotic. During the first two weeks, to avoid eventual side effects, PS participants will be advised to consume the contents of one sachet at breakfast only. Starting in week 3 until the end of the 8-weeks intervention the participants will consume the content of two sachets daily (at breakfast and at dinner) resulting in a total dose of 15 grams of prebiotic per day. Participants will be provided with a package of sachets in the amount required for the whole 8-weeks nutritional intervention. They will be instructed to dissolve the sachet content with water or juice and to drink it 15-20 minutes prior to their regular meal. The medium for suspending the supplement (water or juice) could be chosen by the participants and could be changed during the study.
MaltodextrinDietary supplement
This supplement will be portioned into moisture-impermeable sachets containing 7.5 grams of maltodextrin. During the first two weeks, to avoid eventual side effects, PS participants will be advised to consume the contents of one sachet at breakfast only. Starting in week 3 until the end of the 8-week intervention the participants will consume the content of two sachets daily (at breakfast and at dinner) resulting in a total dose of 15 grams of placebo per day. Participants will be provided with a package of sachets in the amount required for the whole 8-weeks nutritional intervention. They will be instructed to dissolve the sachet content with water or juice and to drink it 15-20 minutes prior to their regular meal. The medium for suspending the supplement (water or juice) could be chosen by the participants and could be changed during the study.
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Adult women and men (N = 35) with mild psoriasis (Psoriasis Area and Severity Index; PASI < 10) will receive 15g of prebiotic (chicory-derived inulin-type β-fructans) daily for 8 weeks Receives: Dietary Supplement: Chicory-derived inulin-type β-fructans |
| Placebo | Placebo comparator | Adult women and men (N = 35) with mild psoriasis (Psoriasis Area and Severity Index; PASI < 10) will receive 15g of placebo (maltodextrin) daily for 8 weeks Receives: Dietary Supplement: Maltodextrin |
| Control | No intervention | Healthy adult women and men (N = 30) will not receive any dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of inflammatory mediators
The concentration of cytokines and chemokines: interferon-γ, interleukins: 1β, 1ra, 2, 4, 5, 6, 7, 8, 9, 10, 12 (p70), 13, 15, 17A, and tumor necrosis factor-α will be analyzed in blood using dedicated assay kit (Bio-Plex Pro Human Cytokine Assay; Bio-Rad)
Measured: 24 months
Secondary outcomes (18)
Assessment of the score of the psoriasis area and severity index (PASI)
The psoriasis area and severity index (PASI) combines the assessment of the severity of and area affected by psoriasis into a single score in the range 0 (no disease) to 72 (maximal disease).
Measured: 24 months
Determination of the body mass index
The body height (in meters) and body weight (in kilograms) will be measeure and will be combined to report body mass index (BMI) in kg/m^2
Measured: 24 months
Analysis of the concentration of anti-tissue transglutaminase antibodies
The concentration of anti-tissue transglutaminase antibodiesanty-tTG will be determined in blood serum according to standard procedures in the outpatient clinic of the Municipal Hospital in Olsztyn.
Measured: 24 months
Analysis of the body composition
Body composition (percentage of total body fat, water, fat-free mass) will be assessed using a bioelectrical impedance analyser
Measured: 24 months
Analysis of the concentration of C-reactive protein (CRP)
The concentration of the C-reactive protein (CRP) will be analyzed according to standard procedures in the outpatient clinic of the Municipal Hospital in Olsztyn. Serum anty-tTG will be determined to exclude the gluten-related disorders
Measured: 24 months
Assessment of liver functions
The concentration of aspartate aminotransferase and alanine aminotransferase will be analyzed according to standard procedures in the outpatient clinic of the Municipal Hospital in Olsztyn.
Measured: 24 months
Analysis of the concentration of creatinine
The concentration of creatinine will be analyzed in urine according to standard procedures in the outpatient clinic of the Municipal Hospital in Olsztyn.
Measured: 24 months
Determination of carbohydrate metabolism
The concentration of glycated hemoglobin, glucose and insulin will be determined in fasting blood and analyzed according to standard procedures in the outpatient clinic of the Municipal Hospital in Olsztyn.
Measured: 24 months
Determination of lipids metabolism
The concentration of apolipoproteins A and B will be determined in fasting blood and analyzed according to standard procedures in the outpatient clinic of the Municipal Hospital in Olsztyn.
Measured: 24 months
Metabolic rate analysis
The resting energy expenditure will be measured by indirect respirometry with ventilated open-circuit (with canopy system) using Cosmed K5 mobile device, in conditions of thermal comfort, under fasting conditions, and in the supine position. Determining the volume of oxygen and carbon dioxide enables the determination of respiratory quotients and the degree of utilization of fat and carbohydrates in the body.
Measured: 24 months
Assessment of qualitative and quantitative changes in the intestinal microbiota
The hyper-variable regions of the 16S rRNA bacterial gene (V3-V8) will be amplified. Bacterial libraries will be created using a Ligation Sequencing Kit 1D plus either Native Barcoding Expansion or a set of custom barcodes. Final libraries will be sequenced on a GridION X5 sequencer (Oxford Nanopore Technologies, Oxford, UK). High-quality reads will be processed for taxonomic identification by matching the NGS sequences with sequences deposited in the NCBI using a modified uSEARCH algorithm.
Measured: 24 months
Assessment of the metabolic activity of intestinal microbiota
The concentration and profile of short-chain fatty acids (SCFA) will be analyzed using the gas chromatograph with a flame-ionization detector and the autosampler in stool samples collected from patients after nutritional intervention with prebiotic or placebo.
Measured: 24 months
Determination of changes in the expression of genes of inflammatory response in skin
Changes in the expression of genes of inflammatory response will be determined by real-time PCR in skin biopsies collected from patients after nutritional intervention with prebiotic or placebo
Measured: 24 months
Immunohistological skin analysis
The concentration of tumor necrosis factor-α, interleukins 17A, 17F, 12, 23, 8, 22, 35, and interferon-gamma will be determined in lesional and non-lesional skin specimens collected from study participants.
Measured: 24 months
Determination of the concentration of biomarkers of intestinal barrier permeability and integrity
The concentration of the selected intestinal barrier permeability and integrity biomarkers will be analyzed using the ELISA method in the blood (zonulin, iFABP, claudin-3, bacterial LPS) and in stool (calprotectin, β-defensin-2, α1-Antitrypsin, sIgA) samples.
Measured: 24 months
Determination of the activity of oxidative stress parameters
Superoxide dismutase activity and catalase activity will be analyzed in blood serum
Measured: 24 months
Qualitative characteristics of volatile organic compounds
The profile of volatile organic compounds will be determined by headspace microextraction coupled with gas-chromatography and mass spectrometry in urine and stool samples
Measured: 24 months
Determination of the nutritional status
Nutritional status will be evaluated based on Food Frequency Questionnaire and a 3-days food record
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start2 Feb 2023
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polish Academy of Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Warmia and Mazury, Warsaw University of Life Sciences
- Responsible party
- Principal investigator, Urszula Krupa-Kozak, Polish Academy of Sciences
- Investigators
- Urszula Krupa-Kozak, PhD, Principal investigator, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences in Olsztyn, PolandAgnieszka Owczarczyk-Saczonek, Prof, Principal investigator, Faculty of Medical Sciences of the University of Warmia and Mazury in Olsztyn, PolandEwa Lange, PhD, Principal investigator, Institute of Human Nutrition Sciences, Warsaw University Of Life Sciences (SGGW), Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971992
- Sponsor's protocol ID
- 2022/45/B/NZ9/03004
- Acronym
- INGUTSKIN
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results presented as average (+/- SD) or median will be successively made available in the form of English-language scientific publications in the Open Access format published in international journals and/or presented in the form of conference reports.
Publications
Bieglecka K, Keszycka PK, Czerwinska J, Pastuszak K, Lange E, Owczarczyk-Saczonek A, Krupa-Kozak U. 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 Jun 8;18(12):1843. doi: 10.3390/nu18121843.
PubMed 42356231Krupa-Kozak U, Owczarczyk-Saczonek A, Lange E, Starowicz M, Kopcewicz M, Keszycka P, Czerwinska J, Rybak-d'Obyrn J, Oczkowski M, De Biasi J, Bieglecka K, Kleniewska M, Baczek N, Malkowska J, Pastuszak K. INulin-type beta-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 Mar 17;25(1):52. doi: 10.1186/s12937-026-01316-8.
PubMed 41840402
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05971992
- Acronym / sponsor ID
- INGUTSKIN / 2022/45/B/NZ9/03004
- Conditions
- Psoriasis
- Keywords
- prebiotics, inulin-type fructans, chronic skin inflammation, inflammatory mediators and cytokines, intestinal barrier permeability, Psoriasis Area and Severity Index, dysbiosis, metabolic dysregulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Polish Academy of SciencesUniversity, hospital or other
- Collaborators
- University of Warmia and Mazury, Warsaw University of Life Sciences
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The gut microbiota contributes to the health of the host. It enables the digestion of food, the proper functioning of the immune system, and protection against the invasion of pathogens. The gut microorganisms play a key role in maintaining the integrity of the intestinal epithelium. The epithelium serves as a selective barrier that, on the one hand, separates the immune cells of the intestinal mucosa from the microorganisms present in the lumen of the gut, and at the same time allows microbial metabolites to interact with the host cells and thus regulate the immune response. Dysbiosis of the intestinal microflora may result in damage to the intestinal integrity and, consequently, an increase in the permeability of the intestinal barrier. The translocation of bacterial antigens and metabolites into the bloodstream contributes to the activation of the local and systemic immune response resulting in local and systemic inflammation. Disruption of the interaction between the gut microbiome and the host can lead to inflammation. Plaque psoriasis is a chronic, immune-mediated dermatitis. It is manifested by peeling, itching, and reddening of the skin. Psoriasis is a non-communicable disease 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. The etiology of psoriasis development is not fully understood. In addition to genetic predisposition, the increased immune response in PS may be a consequence of systemic inflammation due to intestinal dysbiosis associated with increased intestinal permeability.
Dietary ingredients support skin health. Among them, prebiotics gained our special interest as ingredients with proven beneficial effects on host health by modulating gut microflora. Inulin-type fructans derived from chicory are prebiotics that favorably alters the composition and activity of the intestinal microbes and alleviates the inflammation in the intestines. The investigators supposed that restoring the balance of the gut microbiota 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 aim of the research is to determine whether dietary supplementation with inulin-type β-fructans derived from chicory will transfer health benefits to individuals with psoriasis and to investigate whether these benefits are due to modification of the composition or activity of the gut microbiota.
To achieve this goal, the original, advanced, and complex studies were proposed on subjects with psoriasis to investigate the effects of dietary inulin-type fructans on the characteristics of the gut microflora, metabolic parameters, and biomarkers of the skin-gut axis. The obtained results will provide new knowledge and explain the nature of the interaction between the gut microbiota and the skin, providing further clues about the functioning of the gut-skin axis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: Chicory-derived inulin-type β-fructansAdult women and men (N = 35) with mild psoriasis (Psoriasis Area and Severity Index; PASI < 10) will receive 15g of prebiotic (chicory-derived inulin-type β-fructans) daily for 8 weeks |
| Placebo | Placebo comparator | Dietary Supplement: MaltodextrinAdult women and men (N = 35) with mild psoriasis (Psoriasis Area and Severity Index; PASI < 10) will receive 15g of placebo (maltodextrin) daily for 8 weeks |
| Control | No intervention | –Healthy adult women and men (N = 30) will not receive any dietary intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- other chronic or acute inflammatory skin diseases,
- gastrointestinal disease, cancer, cardiovascular complications, heart, kidney, and liver failure,
- bad or average overall health,
- positive tTG antibodies,
- currently receive anti-psoriatic systemic and biologic treatment,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chicory-derived inulin-type β-fructansAlso: Orafti®Synergy1 (Beneo, Tienen, Belgium)This supplement will be portioned into moisture-impermeable sachets containing 7.5 grams of prebiotic. During the first two weeks, to avoid eventual side effects, PS participants will be advised to consume the contents of one sachet at breakfast only. Starting in week 3 until the end of the 8-weeks intervention the participants will consume the content of two sachets daily (at breakfast and at dinner) resulting in a total dose of 15 grams of prebiotic per day. Participants will be provided with a package of sachets in the amount required for the whole 8-weeks nutritional intervention. They will be instructed to dissolve the sachet content with water or juice and to drink it 15-20 minutes prior to their regular meal. The medium for suspending the supplement (water or juice) could be chosen by the participants and could be changed during the study. | Dietary supplement | Prebiotic |
| MaltodextrinThis supplement will be portioned into moisture-impermeable sachets containing 7.5 grams of maltodextrin. During the first two weeks, to avoid eventual side effects, PS participants will be advised to consume the contents of one sachet at breakfast only. Starting in week 3 until the end of the 8-week intervention the participants will consume the content of two sachets daily (at breakfast and at dinner) resulting in a total dose of 15 grams of placebo per day. Participants will be provided with a package of sachets in the amount required for the whole 8-weeks nutritional intervention. They will be instructed to dissolve the sachet content with water or juice and to drink it 15-20 minutes prior to their regular meal. The medium for suspending the supplement (water or juice) could be chosen by the participants and could be changed during the study. | Dietary supplement | Placebo |
Primary outcome
Concentration of inflammatory mediators
Time frame: 24 months
The concentration of cytokines and chemokines: interferon-γ, interleukins: 1β, 1ra, 2, 4, 5, 6, 7, 8, 9, 10, 12 (p70), 13, 15, 17A, and tumor necrosis factor-α will be analyzed in blood using dedicated assay kit (Bio-Plex Pro Human Cytokine Assay; Bio-Rad)
18 secondary outcomes
Assessment of the score of the psoriasis area and severity index (PASI)
Time frame: 24 months
Determination of the body mass index
Time frame: 24 months
Analysis of the concentration of anti-tissue transglutaminase antibodies
Time frame: 24 months
Analysis of the body composition
Time frame: 24 months
Analysis of the concentration of C-reactive protein (CRP)
Time frame: 24 months
Assessment of liver functions
Time frame: 24 months
Analysis of the concentration of creatinine
Time frame: 24 months
Determination of carbohydrate metabolism
Time frame: 24 months
Determination of lipids metabolism
Time frame: 24 months
Metabolic rate analysis
Time frame: 24 months
Assessment of qualitative and quantitative changes in the intestinal microbiota
Time frame: 24 months
Assessment of the metabolic activity of intestinal microbiota
Time frame: 24 months
Determination of changes in the expression of genes of inflammatory response in skin
Time frame: 24 months
Immunohistological skin analysis
Time frame: 24 months
Determination of the concentration of biomarkers of intestinal barrier permeability and integrity
Time frame: 24 months
Determination of the activity of oxidative stress parameters
Time frame: 24 months
Qualitative characteristics of volatile organic compounds
Time frame: 24 months
Determination of the nutritional status
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 42356231Bieglecka K, Keszycka PK, Czerwinska J, Pastuszak K, Lange E, Owczarczyk-Saczonek A, Krupa-Kozak U. 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 Jun 8;18(12):1843. doi: 10.3390/nu18121843.
- Derived from this study: PubMed 41840402Krupa-Kozak U, Owczarczyk-Saczonek A, Lange E, Starowicz M, Kopcewicz M, Keszycka P, Czerwinska J, Rybak-d'Obyrn J, Oczkowski M, De Biasi J, Bieglecka K, Kleniewska M, Baczek N, Malkowska J, Pastuszak K. INulin-type beta-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 Mar 17;25(1):52. doi: 10.1186/s12937-026-01316-8.
- Individual participant dataSharing planned: No. Research results presented as average (+/- SD) or median will be successively made available in the form of English-language scientific publications in the Open Access format published in international journals and/or presented in the form of conference reports.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urszula Krupa-Kozak, PhD principal investigator
Institute of Animal Reproduction and Food Research of Polish Academy of Sciences in Olsztyn, Poland
Agnieszka Owczarczyk-Saczonek, Prof principal investigator
Faculty of Medical Sciences of the University of Warmia and Mazury in Olsztyn, Poland
Ewa Lange, PhD principal investigator
Institute of Human Nutrition Sciences, Warsaw University Of Life Sciences (SGGW), Poland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chicory-derived inulin-type β-fructans and Maltodextrin in people with Psoriasis, run by Polish Academy of Sciences at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of inflammatory mediators (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05971992, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.