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Completed

NCT Number: NCT06200129

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

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.

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Key information

Conditions

Duodenal Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases White Spot Lesion

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sws grade 1

Diagnostic Test

Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 1.

sws grade 2

Diagnostic Test

Blood for zonulin level was drawn from the group of patients with typical white lesions in the duodenum, called grade 2

Control

Diagnostic Test

Group of patients without scattered white lesions in the dueodenum on endoscopy.

Primary outcomes

  1. zonulin levels

    Time frame: immediately after the procedure

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

Secondary outcomes

  1. Duodenal and gastric pathologic conditions

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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