NCT06026449

Brief Summary

Primary sclerosing cholangitis (PSC) is a progressive disease of the biliary tree, which represents one of the most frequent indications for orthotopic liver transplantation (OLTx) in developed countries. There are several lines of evidence that dietary gluten/gliadin displays chronic pro-inflammatory, LPS-like properties. Recent evidence demonstrated the protective effect of gluten- free diet (GFD) in autoimmune diseases like type 1 diabetes, irritable bowel syndrome, non-celiac gluten sensitivity and some neurological disorders. This study is intended to explore therapeutic effect of GFD on PSC and IBD in prospective self-controlled mono-centric intervention study. Hypothesis: Avoidance of gluten in diet will reduce progression, symptoms and intestinal inflammation in PSC and UC patients.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jan 2023Dec 2026

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3 years

First QC Date

March 27, 2023

Last Update Submit

January 7, 2026

Conditions

Primary Sclerosing CholangitisUlcerative ColitisBiliary Tract DiseasesBiliary Disease TractIntestinal Disease

Keywords

Primary sclerosing cholangitisCholangitisGluten-free dietUlcerative ColitisMicrobiome

Outcome Measures

Primary Outcomes (2)

  • Decrease of laboratory markers of cholestasis

    Change of alkaline phosphatase \> 25% or normalisation.

    6-12 months

  • Changes of intestinal microbiome composition.

    16S-rRNA sequencing

    6-12 months

Secondary Outcomes (5)

  • Changes of morphological signs of intestinal inflammation

    6-12 months

  • Improvement of quality of life and symptoms of ulcerative colitis.

    6-12 months

  • Improvement of quality of life and symptoms of primary sclerosing cholangitis

    6-12 months

  • Changes of histopathological signs of intestinal inflammation

    6-12 months

  • Change from baseline of liver stiffness.

    6-12 months

Study Arms (2)

Primary sclerosing cholangitis

EXPERIMENTAL
Dietary Supplement: Gluten-free diet

Ulcerative Colitis

EXPERIMENTAL
Dietary Supplement: Gluten-free diet

Interventions

Gluten-free dietDIETARY_SUPPLEMENT

After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months

Primary sclerosing cholangitisUlcerative Colitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established diagnosis of PSC (based on radiologic features, typical finding on MRCP or ERCP)
  • Age 18 - 65 years
  • ALP 1,5x higher than ULN
  • Signed informed consent

You may not qualify if:

  • Patients on gluten-free diet
  • Patients with coeliac disease or wheat allergy
  • Liver transplant recipients
  • PSC/AIH overlap syndrome
  • Other causes of liver disease
  • Radiologic or clinical signs of decompensated liver cirrhosis
  • Advanced liver cirrhosis (MELD score ˃ 15)
  • Recurrent acute cholangitis or cholangiogenic sepsis in past 3 months
  • Use of antibiotics in past 3 months
  • History of malignancy
  • Pregnant women
  • Not signed informed consent
  • Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings
  • Extension of affected colon \> 15cm
  • Mayo score 0-4
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of clinical and experimental medicine

Prague, Prague, 14021, Czechia

Location

MeSH Terms

Conditions

Cholangitis, SclerosingColitis, UlcerativeBiliary Tract DiseasesIntestinal DiseasesCholangitis

Interventions

Diet, Gluten-Free

Condition Hierarchy (Ancestors)

Bile Duct DiseasesDigestive System DiseasesColitisGastroenteritisGastrointestinal DiseasesInflammatory Bowel DiseasesColonic Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, self-controlled pilot clinical trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior consultant

Study Record Dates

First Submitted

March 27, 2023

First Posted

September 7, 2023

Study Start

January 1, 2023

Primary Completion

January 7, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)