NCT06200129

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
Last Updated

January 10, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 29, 2023

Last Update Submit

December 29, 2023

Conditions

Duodenal DiseasesWhite Spot Lesion

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Duodenal and gastric pathologic conditions

    During the endoscopy

Study Arms (3)

sws grade 1

EXPERIMENTAL

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

Diagnostic Test: sws grade 1

sws grade 2

EXPERIMENTAL

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

Diagnostic Test: sws grade 2

control

EXPERIMENTAL

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

Diagnostic Test: control

Interventions

sws grade 1DIAGNOSTIC_TEST

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

sws grade 1
sws grade 2DIAGNOSTIC_TEST

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

sws grade 2
controlDIAGNOSTIC_TEST

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

control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Abdurrahman Yurtaslan Oncology Training and Research Hospital

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 22260755RESULT

  • 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.

    PMID: 16265432RESULT

  • 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.

    PMID: 19906109RESULT

MeSH Terms

Conditions

Duodenal Diseases

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • semih sezer

    clinic physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinic physician

Study Record Dates

First Submitted

December 29, 2023

First Posted

January 10, 2024

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 10, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)