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Scleroderma, Systemic clinical trials

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NCT ID: NCT03692299 Completed - Systemic Sclerosis Clinical Trials

Effectiveness of Saccharomyces Boulardii for Gastrointestinal Bacterial-overgrowth in Systemic Sclerosis

Start date: June 2015
Phase: Phase 4
Study type: Interventional

Introduction. Autonomic dysfunction, smooth muscle fibrosis and vascular damage lead to small intestinal bacterial overgrowth (SIBO) in Systemic Sclerosis (SSc). SIBO is characterized by diarrhea, abdominal pain, bloating, malabsorption and malnutrition. Aim. To evaluate the efficacy and safety of Saccharomyces boulardii in combination with metronidazole for 2 months for reducing gastrointestinal symptoms (NIH-PROMIS) and preventing bacterial overgrowth (hydrogen breath test) versus the standard treatment in patients with systemic sclerosis. Method. Controlled clinical trial conduct in patients with SSc (ACR-EULAR 2015) who signed informed consent. NIH PROMIS®questionarie will be apply to evaluate gastrointestinal symptoms and classify in not symptomatic, least, mildy, moderately and most symptomatic. Glucose HBT will be apply after 14 hours fast, oral hygiene and 30 days free of antibiotics to evaluate SIBO. Patients with negative HBT and symptoms associated to glucose ingestion will repeat test with lactulose. Patients will be aleatorized into 1. Saccharomyces boulardii, 2. Metronidazole and 3. Metronidazole plus Saccharomyces boulardii. All data will be analyzed using SPSS software. It will be used parametric statistics for normally distributed variables and nonparametric statistics for free distribution.

NCT ID: NCT03678987 Completed - Systemic Sclerosis Clinical Trials

Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis

MMFSSC
Start date: September 13, 2018
Phase:
Study type: Observational

Drug of investigation: Mycophenolate mofetil (MMF), given orally as a tablet twice daily. Dosage of drug: This study recruits patients who have been prescribed a steady dose of MMF in the range between 1000 and 3000 mg daily by their physician. Design: This is an open-label PK study. Disease studied: Systemic sclerosis (SSC, scleroderma). Variables assessed: Estimated AUC0-12 for MMF. Gastrointestinal manifestations of SSc. Concomitant medication. Study population: Inclusion criteria: Diagnosis of SSC fulfilling the 2013 classification criteria for this disease. Participant should have been prescribed a stable dose of MMF tablets, taken twice daily, for at least 3 months prior to the study. Exclusion criteria: Failure to comply with study protocol. Limited access to repeated venous puncture. Recipient of organ transplant. Pulmonary arterial hypertension. Number of participants: The study aims at the inclusion of 35 subjects. Primary objective: To investigate the PK of orally ingested MMF in SSC. Secondary objectives: 1. To investigate how SSC manifested in the gastrointestinal (GI) tract may alter the PK of MMF. 2. To investigate how the PK of MMF in SSc is altered by medications often used in SSC, i.e. proton pump inhibitors (PPI), NSAID and calcium channel blockers.

NCT ID: NCT03675581 Completed - Clinical trials for Scleroderma, Systemic

A Study to Test Whether Nintedanib Influences the Components of Birth-control Pills in Women With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)

Start date: November 8, 2018
Phase: Phase 1
Study type: Interventional

The main objective is to assess the potential influence of continuous intake of nintedanib on the systemic exposure of ethinylestradiol and levonorgestrel when administered in combination.

NCT ID: NCT03644225 Completed - Systemic Sclerosis Clinical Trials

Suction Based Characterization of Healthy and Diseased Skin

Start date: June 11, 2018
Phase: N/A
Study type: Interventional

The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements. The negative pressure needed to gain a certain tissue elevation, tissue elevation in response to a certain negative pressure as well as the time of retraction of tissue will be recorded and analyzed. Mesurments will be done with the new developed Aspiration Device_Nimble and with the CE-certified Cutometer MPA 580.

NCT ID: NCT03614208 Completed - Systemic Sclerosis Clinical Trials

Individualized Home-based Exercise Program for Patient With Systemic Sclerosis.

ESSE2016
Start date: February 1, 2017
Phase: N/A
Study type: Interventional

Systemic sclerosis (SSc) is an uncommon chronic rheumatic disease with an unknown cause and unpredictable course. The inability, in addition to easy fatigability, starts a vicious circle that leads to a fast deterioration of physical conditions that cause a reduction of aerobic exercise capacity and, consequently, of health-related quality of life (HRQoL). Aerobic exercise has already been shown to be safe and effective in improving exercise capacity and HRQoL of patients with chronic cardiovascular and pulmonary diseases. However, few studies have evaluated the role of specific exercise programs on the muscular impairment in SSc. Nevertheless, the results obtained in preliminary reports are promising, and, for these reasons, the management of muscular impairment in SSc could include an appropriate rehabilitation program besides pharmaceutical and surgical treatments. The primary aim of this study will be to evaluate the effect of an individualized exercise program performed at home on aerobic capacity evaluated by 6 minutes walking test. Secondary aims will be to evaluate: 1- VO2max, measured by cardiopulmonary test; 2- the effect of the same program on the muscular strength of upper and lower limbs; 3- the efficacy of a self-administered stretching program for finger joint motion. Secondary aims will be also 1-to ascertain whether a comprehensive exercise program may affect, besides physical function, HRQoL; 2- and to evaluate the adherence during two periods of three months, one whit and one without supervision and reinforcement by a phone call. All the patients with a diagnosis of SSc, according to the criteria of American College of Rheumatology (ACR), who attended the Rheumatologic outpatient clinic of our institution will be evaluated in order to participate in the rehabilitation program. The pneumological examination and two days of screening and testing will take place at the outpatient's clinic of Respiratory Medicine and Sport of our institution.

NCT ID: NCT03601520 Completed - Clinical trials for Diffusion Limitation of Pulmonary Gas Exchange in Systemic Sclerosis

Mechanisms of Pulmonary Diffusion Limitation in Systemic Sclerosis

DL-SSc
Start date: March 1, 2014
Phase:
Study type: Observational

This study was designed to test the hypothesis that, irrespective of the degree of interstiaI lung disease and/or pulmonary arterial hypertension, the combined measurement of lung diffusing capacity for nitric oxide and carbon monoxide, might be useful to provide a mechanistic interpretation of changes of diffusion subcomponents in systemic sclerosis (SSc).

NCT ID: NCT03575156 Completed - Clinical trials for Systemic Lupus Erythematosus

Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

MICROLUPS
Start date: September 20, 2018
Phase: N/A
Study type: Interventional

Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.

NCT ID: NCT03561233 Completed - Systemic Sclerosis Clinical Trials

Prevalence and Predictors of Proton Pump Inhibitor Partial Response in Gastroesophageal Reflux Disease in Systemic Sclerosis

Start date: May 2013
Phase: Phase 1
Study type: Interventional

Proton pump inhibitor (PPI) twice daily dosing regimen—a standard dose therapy for gastroesophageal reflux disease (GERD)—is an effective therapy for uncomplicated GERD in systemic sclerosis (SSc) but there is no data of response rate of standard dose of PPI and predictors of PPI-partial response (PPI-PR) GERD in SSc.Objectives of the study were to determine the prevalence of omeprazole partial response GERD in SSc and to define the predictors of PPI-PR GERD in SSc. Adult SSc patients having GERD were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. Severity of symptom-grading by visual analogue scale (VAS) and frequency of symptoms by frequency scale for symptoms of GERD (FSSG) were assessed at baseline and 4 weeks after treatment. PPI-PR GERD was defined by less than 50% improvement in VAS of severity of symptom and acid reflux score by FSSG after treatment compare to baseline.

NCT ID: NCT03558854 Completed - Systemic Sclerosis Clinical Trials

Evaluation of Effectiveness of Acetylsalicylic Acid on Markers of Vascular Dysfunction in Scleroderma Patients

Start date: August 28, 2018
Phase: Phase 4
Study type: Interventional

Systemic sclerosis is a chronic autoimmune disease characterized by vascular changes in the microcirculation (small blood vessels) and progressive fibrosis of the skin and internal organs. It is believed that vascular changes, expressed early by the Raynaud phenomenon, precede fibrosis and organic dysfunction. There is no available treatment that reverses the vascular damage caused by the disease to the moment, although there are several medications recommended for the relief of manifestations due to vascular injury. Acetylsalicylic acid (ASA) is one of the medications that can be used for the treatment of vascular injury present in systemic sclerosis, but still without a fully proven benefit. This study aims to evaluate the effectiveness of ASA on microcirculation alterations in patients with systemic sclerosis by performing three exams: periungual panoramic capillary microscopy, videocapillaroscopy and laser Doppler imaging. In addition, a blood sample will be collected for dosing the following vascular lesion markers: endothelin-1, von Willebrand factor, thromboxane, and platelet-derived, endothelial-derived and monocyte-derived microparticles.

NCT ID: NCT03543956 Completed - Systemic Sclerosis Clinical Trials

Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition

VISSEXPOSITION
Start date: June 4, 2018
Phase:
Study type: Observational

Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.