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

Not Applicable

Completed

• Conditions: White Spot Lesion; Duodenal Diseases
• Interventions: Diagnostic Test: control; Diagnostic Test: sws grade 2; Diagnostic Test: sws grade 1

• Registration Number: NCT06200129
• Lead Sponsor: Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

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.

Study Timeline

• Study Start: 2023-09-01
• Status Verified: 2023-12
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Study First Submitted: 2023-12-29
• Study First Submitted QC: 2023-12-29
• Last Update Submitted: 2023-12-29
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	control	The group with a normal appearance of the duodenal mucosa, where scattered white spots were not detected.
sws grade 2	sws grade 2	The group that defined as a diffuse or patchy white appearance on villi that could not be wiped away by washing on the mucosa.
sws grade 1	sws grade 1	The group that defined as scattered white spots on the normal duodenal mucosa that could not be wiped away by washing, appearing as white spots

Primary Outcome Measures

Name	Time	Method
zonulin levels	immediately after the procedure	Patients with scattered white spots in the duodenum had blood drawn for zonulin level immediately after the procedure.

Secondary Outcome Measures

Name	Time	Method
Duodenal and gastric pathologic conditions	During the endoscopy	Biopsies from the duodenum and gastric antrum and corpus were taken during the endoscopy from patients with scattered white spots in the duodenum.

Trial Locations

Locations (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital; 🇹🇷 Ankara, Turkey