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Gallstones and Concomitant Gastric Helicobacter Pylori Infection

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by M.Umit UGURLU, Marmara University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01810081
First Posted: March 13, 2013
Last Update Posted: March 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.Umit UGURLU, Marmara University
  Purpose
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.

Condition
Cholelithiasis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Relationship Between Gallstones and Concomitant Gastric Helicobacter Pylori Infection

Resource links provided by NLM:


Further study details as provided by M.Umit UGURLU, Marmara University:

Primary Outcome Measures:
  • Gallstones and concomitant H.Pylori infection of the gastric mucosa [ Time Frame: 3 months ]
    The relationship between gastric H.Pylori infection and comcomitant gallstones will be evaluated


Estimated Enrollment: 94
Study Start Date: March 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
cholecystectomy
cholecystectomy group: H.Pylori infection in gall bladder

Detailed Description:

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.

  Eligibility

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Ninety-four patients with symptomatic gallstones undergoing laparoscopic cholecystectomy were enrolled for the study.
Criteria

Inclusion Criteria:

  • Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810081


Contacts
Contact: M.Umit UGURLU, MD +905324108010 umitugurlu@gmail.com

Locations
Turkey
marmara University School of Medicine Not yet recruiting
Istanbul, Turkey
Contact: M.Umit UGURLU, MD    +905324108010    umitugurlu@gmail.com   
Sponsors and Collaborators
Marmara University
Investigators
Study Director: A.Ozdemir Aktan, md,PROF Marmara University
  More Information

Responsible Party: M.Umit UGURLU, Assist.Prof., Marmara University
ClinicalTrials.gov Identifier: NCT01810081     History of Changes
Other Study ID Numbers: B.30.2.MAR.0.01.02/AEK/73
First Submitted: March 6, 2013
First Posted: March 13, 2013
Last Update Posted: March 13, 2013
Last Verified: March 2013

Keywords provided by M.Umit UGURLU, Marmara University:
Cholelithiasis
Gastric H.Pylori infection
H.Pylori infection
Gastric mucosa

Additional relevant MeSH terms:
Infection
Helicobacter Infections
Gallstones
Cholelithiasis
Cholecystolithiasis
Gram-Negative Bacterial Infections
Bacterial Infections
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical