Gastric emptying in systemic sclerosis

JRCT ID: jRCTs031200019

Registered date:21/04/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Systemic sclerosis
• Date of first enrollment: 01/04/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Gastric emptying in patients with systemic sclerosis will be evaluated by 13C breath test. In particular, patients will take test meal with acetate labelled with 13C and their breaths will be evaluated.

Outcome(s)

• Primary Outcome: prevalence of delayed gastric emptying
• Secondary Outcome: time of gastic emptying, esophageal motility abnormarlities, GI symptoms, slin involvements, lung involvements, findings in ECG or cardiac echo, renal involvements, autoantibodies, QOL, baseline patients' characteristics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) 20 year-old or older than 20 year-old
2) patients who are diagnosed with systemic sclerosis based on the guidelines for systemic sclerosis
3) patients who underwent esophageal manometry and who uderwent esophagogastroduodenoscopy, chest CT, ECG and cardiac echo within one year before the enrolment of the study
4) patients who can have written consent to participate in the study

Exclude criteria

1) Patients who underwent upper GI surgery
2) Patients who have allergy for test diets or milk protein
3) Patients who cannot withdraw prokinetic agents

Related Information

• Primary Sponsor: Kuribayashi Shiko
• Secondary Sponsor: Uraoka Toshio