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

NCT05971992 | Completed

• 1 other identifier: 2022/45/B/NZ9/03004
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief 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. 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).

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; 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

Outcome Measures

Primary Outcomes (1)

• 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)

  24 months

Secondary Outcomes (18)

• Assessment of the score of the psoriasis area and severity index (PASI)

  24 months

• Determination of the body mass index

  24 months

• Analysis of the concentration of anti-tissue transglutaminase antibodies

  24 months

• Analysis of the body composition

  24 months

• Analysis of the concentration of C-reactive protein (CRP)

  24 months

Study Arms (3)

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

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

Dietary Supplement: Maltodextrin

Control

NO INTERVENTION

Healthy adult women and men (N = 30) will not receive any dietary intervention

Interventions

Chicory-derived inulin-type β-fructans DIETARY_SUPPLEMENT

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.

Also known as: Orafti®Synergy1 (Beneo, Tienen, Belgium)

Prebiotic

Maltodextrin DIETARY_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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: women and men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Polish Academy of Sciences: lead
• University of Warmia and Mazury: collaborator
• Warsaw University of Life Sciences: collaborator

Study Sites (2)

Chair and Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology, Municipal Hospital Complex, al. Wojska Polskiego 30

Olsztyn, 10-229, Poland

Location

Institute of Animal Reproduction and Food Research, Polish Academy of Sciences, ul. Tuwima 10

Olsztyn, 10-748, Poland

Location

MeSH Terms

Conditions

Psoriasis; Dysbiosis

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Urszula Krupa-Kozak, PhD

  Institute of Animal Reproduction and Food Research of Polish Academy of Sciences in Olsztyn, Poland

  PRINCIPAL INVESTIGATOR

• Agnieszka Owczarczyk-Saczonek, Prof

  Faculty of Medical Sciences of the University of Warmia and Mazury in Olsztyn, Poland

  PRINCIPAL INVESTIGATOR

• Ewa Lange, PhD

  Institute of Human Nutrition Sciences, Warsaw University Of Life Sciences (SGGW), Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: August 2, 2023
• Study Start: February 2, 2023
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)