NCT00366509

Role of Helicobacter Pylori and Its Toxins in Lung and Digestive System Diseases

Completed Last updated 2 August 2021

What this trial tests

trial in Pulmonary Disease in 157 participants. Completed in 27 October 2016.

Timeline

18 September 2006

Primary endpoint
1 January 2016

27 October 2016

Quick facts

Lead sponsor	National Heart, Lung, and Blood Institute (NHLBI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	157
Start date	18 September 2006
Primary completion	1 January 2016
Estimated completion	27 October 2016
Sites	1 location across United States

Conditions studied

• Pulmonary Disease — all drugs for Pulmonary Disease →
• Oropharyngeal Disease — all drugs for Oropharyngeal Disease →
• Lymphangioleiomyomatosis — all drugs for Lymphangioleiomyomatosis →
• Pulmonary Fibrosis — all drugs for Pulmonary Fibrosis →

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Who can join

Adults 18 to 99, any sex, with Pulmonary Disease or Oropharyngeal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will examine bacteria and toxins in the mouth, lung and digestive system that may be the cause of various diseases or symptoms. H. pylori is a bacterium that produces various toxins that may contribute to lung problems. This study will examine specimens collected from the mouth, teeth, lung, digestive tract and blood to measure H. pylori and its toxins and their effects on cells.

People 18 years of age and older with or without gastrointestinal disease may be eligible for this study. These include people without a history of lung disease as well as patients with any of the following: lymphangioleiomyomatosis, asthma, sarcoidosis, other chronic or genetic lung disease (e.g., chronic obstructive pulmonary disease, cystic fibrosis or eosinophilic granuloma).

Participants may undergo the following tests:

* Blood and urine tests, chest x-ray.
* Measurement of arterial blood gases: A small needle is placed in an artery in the forearm to collect arterial blood.
* Lung function tests: Subjects breathe deeply and occasionally hold their breath. They may also receive a medication that expands the airways.
* Fiberoptic bronchoscopy with lavage and bronchial brushing: The subject's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways. Saline (salt water) is then injected through the bronchoscope into the air passage and then removed by gentle suction. Next, a small brush is passed through the bronchoscope and an area of the airway is brushed to collect some cells for examination.
* Mouth rinsing or teeth brushing to collect cells.
* Endoscopy: A small needle and catheter (thin plastic tube) are placed into an arm vein to administer fluids and medications through the vein. A sedative may be given. The throat is numbed with lidocaine and a thin flexible tube called an endoscope is inserted through the mouth and down the esophagus into the stomach and upper part of the small intestine to examine those areas.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.