Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)

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Giriş / Qeydiyyatdan keçin

Bağlantı panoya saxlanılır

StatusTamamlandı

Sponsorlar

Universitätsklinikum Hamburg-Eppendorf

Əməkdaşlar

Institute for Clinical Molecular Biology, Christian-Albrechts-University, Kiel

Johannes Gutenberg University Mainz

KLINIK SINAQ: NCT04006886

BioSeek: nct04006886

Açar sözlər

Mücərrəd

Gluten is a protein found in wheat and other cereals as barley and rye. It triggers an inflammatory reaction in the small-bowel of genetically predisposed persons. Alpha-amylase/trypsin inhibitors (ATIs) of wheat seem to be the responsible trigger of this intestinal Inflammation.

Intestinal inflammation is connected to other extra-intestinal autoimmune inflammations like PSC (as f.ex. the association of PSC with inflammatory bowel disease proves).

Hypothesis: Avoidance of ATIs through a gluten-free diet will reduce intestinal inflammation and thus also the the inflammatory activity in the liver.

Proof of hypothesis:

- Pilot study with n=20 patients with PSC

- Explorative, open-label, mono-centric study

- Inclusion criteria: age 18-65, diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy.

Tarixlər

Son Doğrulandı:	06/30/2019
İlk təqdim:	07/01/2019
Təxmini qeydiyyat təqdim edildi:	07/01/2019
İlk Göndərmə:	07/04/2019
Son Yeniləmə Göndərildi:	07/02/2019
Son Yeniləmə Göndərildi:	07/04/2019
Həqiqi Təhsilin Başlama Tarixi:	07/10/2017
Təxmini İlkin Tamamlanma Tarixi:	05/08/2019
Təxmini İşin Tamamlanma Tarixi:	06/30/2019

Vəziyyət və ya xəstəlik

Reduction of Intestinal Inflammatory Activity

Müdaxilə / müalicə

Dietary Supplement: Gluten-free diet

Faza

Uyğunluq Kriteriyaları

Təhsil üçün uyğun yaşlar	18 Years Üçün 18 Years
Təhsilə Uyğun Cinslər	All
Sağlam Könüllüləri qəbul edir	Bəli
Kriteriyalar	Inclusion Criteria: - diagnosed PSC-associated colitis without relevant clinical activity after last coloscopy. Exclusion Criteria: - patients with coeliac disease or wheat allergy - patients with active colitis - patients already on gluten-free diet - liver transplanted patients - patients also diagnosed with autoimmune hepatites (PSC-AIH overlap) - coloscopy within 2 months before study - Endoscopic retrograde cholangiopancreatography (ERCP) within 3 months before study - antibiotics within 3 month before study

Nəticə

İlkin nəticə tədbirləri

1. Reduction of intestinal inflammatory activity [2 months]

Expression of pro-inflammatory cytokines in gut mucosa (Sigma)

İkincili Nəticə Tədbirləri

1. Inflammatory activity of the liver [2 months]

alkaline phosphatase (AP)

2. Reduction of inflammatory cells/markers in the blood [2 months]

stored blood samples, Pax-Gene

3. Quality of life [2 months]

questionnaire

4. Change of symptoms with change of diet. [2 months]

questionnaire

5. Changes in patients microbiota [2 months (5 months with follow-up)]

stool samples

Gluten-free Diet in Patients With Primary Sclerosing Cholangitis (PSC)

Açar sözlər

i̇ltihab

xolangit

colitis

gluten

alpha amylase

amylase

çovdar

əkin çovdarı