Suspended

Study of Relationship Between Gallstones and Concomitant Gastric Helicobacter Pylori Infection

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Biliary Tract Diseases

+ Digestive System Diseases

+ Cholelithiasis

From 18 to 80 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: March 2013
See protocol details

Summary

Principal SponsorMarmara University
Study ContactM.Umit UGURLU, MDMore contacts
Last updated: March 13, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

Gallstone disease is one of the most common problems affecting the digestive tract where autopsy reports show a prevalence of 11-36% . The prevalence of gallstones is related to many factors including age, gender, and ethnic background. Women are three times more likely to develop gallstones than man and first-degree relatives have a two-fold increased prevalence . However, the etiology of gallstone formation beginning with the change in the composition of bile, leading to stones is not clear. The association between Helicobacter pylori (H.Pylori) and gallstones has been investigated but not clearly demonstrated. H.Pylori is a gram negative and micro-aerophilic microorganism that can cause chronic gastritis, gastric and duodenal ulcers, gastric adenocarcinoma and lymphoma of gastric mucosa-related lymphoid tissue (MALToma) . Relationship of H.Pylori with diseases of organs other than the stomach and duodenum has also been investigated and reported . H.Pylori have been detected in the gallbladder mucosa of patients with gallstones . In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.

Principal SponsorMarmara University
Study ContactM.Umit UGURLU, MDMore contacts
Last updated: March 13, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

94 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Biliary Tract DiseasesDigestive System DiseasesCholelithiasis

Criteria

1 inclusion criteria required to participate
Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation

1 exclusion criteria prevent from participating
Patients undergoing ERCP (endoscopic retrograde cholangio-pancreatography) and patients who have received H.Pylori eradication treatment in the last 6 month were also excluded from the study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

marmara University School of Medicine

Istanbul, Turkey (Türkiye)Open marmara University School of Medicine in Google Maps
SuspendedOne Study Center