İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin

White Spot Lesion Clinical Trial

Official title:

İmportance of Scattered White Spots Detected in the Duodenum and Their Relationship wıth Zonulin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200129
• Other study ID #: zonulinsws
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Duodenal Diseases
• White Spot Lesion

Intervention

Diagnostic Test:
• sws grade 1
Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 1.
• sws grade 2
Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 2
• control
Group of patients without scattered white lesions in the dueodenum on endoscopy.

Locations

Country	Name	City	State
Turkey	Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	zonulin levels	Patients with scattered white spots in the duodenum had blood drawn for zonulin level immediately after the procedure.	immediately after the procedure
Secondary	Duodenal and gastric pathologic conditions	Biopsies from the duodenum and gastric antrum and corpus were taken during the endoscopy from patients with scattered white spots in the duodenum.	During the endoscopy