Ongoing Clinical Trial Seeks To Link Systemic Sclerosis and Gastroesophageal Reflux

A new clinical trial on Systemic Sclerosis (also known as Scleroderma) is now recruiting participants – adult patients (at least 18 years old) with a confirmed diagnosis of systemic sclerosis (SSc), as defined by the American College of Rheumatology criteria — who are willing to participate (the study accepts both males and females).

The study is entitled “Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough” and is composed of two Groups/Cohorts of participants — a group of systemic sclerosis patients with interstitial lung disease (ILD) and a second group of systemic sclerosis patients without interstitial lung disease (ILD). ILD is a definition that comprises several lung diseases, generally characterized by progressive scarring of lung tissue.

A list of exclusion criteria is detailed and includes patients actively smoking within 6 months; patients who suffered from pneumonia or bronchitis (in the last 4 weeks); patients who previously experienced heart failure, infection, or asthma as active acute illness; pregnancy; additional conditions that may undermine a diagnosis of ILD (besides systemic sclerosis), and other additional criteria that can be found here.

The trial is an observational study that aims to determine participants’ airway pepsin concentration as well as participants airway pepsin level, cough frequency, forced vital capacity (FVC), diffusing capacity of the lung for carbon monoxide (DLCO), and CT fibrosis score differences between both groups. The trials’ objective is to determine a link between cough, reflux, and aspiration in patients with systemic sclerosis (scleroderma).

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The trial was first received in August 14, 2012 and the last status updated was registered in April 6, 2015.

The study is headed by Augustine S. Lee, M.D., at the Mayo Clinic. Patients are encouraged to participate but are advised to discuss first with their doctor and family. The application, as well as further information, should include the ClinicalTrials.gov identifier NCT01667042 and can be found here.

For more information please visit the U.S. National Institute of Healths webpage on Clinical Trials, which can be found here.