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

NCT ID: NCT06200129

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Duodenal Diseases White Spot Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

sws grade 1

Intervention Type 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

The group that defined as a diffuse or patchy white appearance on villi that could not be wiped away by washing on the mucosa.

Group Type EXPERIMENTAL

sws grade 2

Intervention Type DIAGNOSTIC_TEST

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

control

The group with a normal appearance of the duodenal mucosa, where scattered white spots were not detected.

Group Type EXPERIMENTAL

control

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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sws grade 1

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

Intervention Type DIAGNOSTIC_TEST

sws grade 2

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

Intervention Type DIAGNOSTIC_TEST

control

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Semih Sezer

clinic physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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semih sezer

Role: PRINCIPAL_INVESTIGATOR

clinic physician

Locations

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Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 22260755 (View on PubMed)

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.

Reference Type RESULT
PMID: 16265432 (View on PubMed)

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.

Reference Type RESULT
PMID: 19906109 (View on PubMed)

Other Identifiers

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zonulinsws

Identifier Type: -

Identifier Source: org_study_id

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