Gluten-free Diet in PSC and IBD | NCT06026449

Studies
Gluten-free Diet in PSC and IBD

NCT06026449

Sponsor

Institute for Clinical and Experimental Medicine

Status

Active, not recruiting

Last Update Posted

Jan 8, 2026Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Primary Sclerosing Cholangitis
Ulcerative Colitis
Biliary Tract Diseases
Biliary Disease Tract
Intestinal Disease

Interventions

Gluten-free diet

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2023Actual

Primary Completion Date

Jan 7, 2026Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Mar 27, 2023

First Submission Date that Met QC Criteria

Aug 30, 2023

First Posted Date

Sep 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 8, 2026Actual

Name	Class
Czech Academy of Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary sclerosing cholangitis	Experimental		Dietary Supplement: Gluten-free diet
Ulcerative Colitis	Experimental		Dietary Supplement: Gluten-free diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten-free diet	Dietary Supplement	After initial fase of habitual diet (6 months), patients will start Gluten-free diet for a period of 12 months	Primary sclerosing cholangitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Changes of morphological signs of intestinal inflammation	Endoscopic Mayo score (Grade 0 - normal or inactive disease; Grade 1 - mild disease acitivity; Grade 2 - moderate disease acitivity; Grade 3 - Severe disease acitivity)	6-12 months
Improvement of quality of life and symptoms of ulcerative colitis.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria (for PSC group):

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

Exclusion Criteria (for PSC group):

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

Inclusion criteria (for UC group):

Ulcerative colitis diagnosed based on clinical, endoscopic and histological findings
Extension of affected colon > 15cm
Mayo score 0-4
Signed informed consent

Exclusion criteria (for UC group):

CMV, Clostridium difficile enterocolitis in past 3 months
Use of antibiotics in past 3 months
Patients with coeliac disease or wheat allergy
Patients on gluten-free diet
Pregnant women
Not signed informed consent
Biologic therapy
Methotrexate
Prednison > 10 mg
Not signed informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Institute of clinical and experimental medicine		Prague	Prague	14021	Czechia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015209	Cholangitis, Sclerosing
D003093	Colitis, Ulcerative
D001660	Biliary Tract Diseases
D007410	Intestinal Diseases
D002761	Cholangitis

Ancestor Terms

ID	Term
D001649	Bile Duct Diseases
D004066	Digestive System Diseases
D003092	Colitis
D005759	Gastroenteritis

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D004035	Diet Therapy
D044623	Nutrition Therapy
D013812	Therapeutics
D004032	Diet
D009747