Clinical trial NCT06200129: İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin
Official title: İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Duodenal Diseases
White Spot Lesion
Lead sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: With our study, we aimed to determine whether there is a correlation between zonulin, which plays a crucial role in intestinal barrier function and is implicated in the etiopathogenesis of many chronic and autoimmune diseases, and scattered white spots lesions associated with lymphatic stasis and inflammation in the duodenum.

Detailed description: During esophagogastroduodenoscopy (EGD), rarely encountered lesions in the duodenum present as scattered white spots (SWS) on the normal mucosa. Although not fully understood in terms of specific association with any particular disease and clinical significance, some studies have often observed chronic non-specific duodenitis (CND) and intestinal lymphangiectasia (IL) in lesions with SWS. This condition is thought to be related to lymphatic stasis.

Patients included 63 individuals with identified SWS during EGD and 30 patients with a normal appearance of the duodenal mucosa were selected as the control group. SWS lesions were categorized into two groups, grade 1 and grade 2, based on the degree of density and endoscopic appearance. Biopsies were taken from the duodenum, antrum, and corpus. It was examined for IL, CND, giardiasis, and villous atrophy. Venous blood samples were collected from all patients for serum zonulin levels.

Eligibility criteria: Inclusion Criteria:

* Patients with scattered white patchy lesions in the duodenum on endoscopy and control group patients with normal duodenum on endoscopy.

Exclusion Criteria:

* active gastroenteritis
* acute kidney failure
* chronic kidney failure
* type-1 diabetes
* inflammatory bowel disease
* duodenal ulcer,
* duodenal tumor
* autoimmune diseases

Primary outcomes:
measure: zonulin levels
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Duodenal and gastric pathologic conditions
timeFrame: During the endoscopy
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital
Study officials:
affiliation: clinic physician
name: semih sezer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tas A, Koklu S, Beyazit Y, Akbal E, Kocak E, Celik H, Biyikoglu I. The endoscopic course of scattered white spots in the descending duodenum: a prospective study. Gastroenterol Hepatol. 2012 Feb;35(2):57-64. doi: 10.1016/j.gastrohep.2011.11.010. Epub 2012 Jan 20.
citation: Fasano A, Shea-Donohue T. Mechanisms of disease: the role of intestinal barrier function in the pathogenesis of gastrointestinal autoimmune diseases. Nat Clin Pract Gastroenterol Hepatol. 2005 Sep;2(9):416-22. doi: 10.1038/ncpgasthep0259.
citation: Biyikoglu I, Babali A, Cakal B, Koklu S, Filik L, Astarci MH, Ustun H, Ustundag Y, Akbal E. Do scattered white spots in the duodenum mark a specific gastrointestinal pathology? J Dig Dis. 2009 Nov;10(4):300-4. doi: 10.1111/j.1751-2980.2009.00399.x.