Effect of Azithromycin on Oesophageal Hypomotility

Inclusion criteria

• Healthy subjects:

• Written ICF signed voluntarily before the first trial-related activity.
• Subjects male and female within age range of 18-70 years old (extremes included)
• BMI <35
• Patients group:

• Written ICF signed voluntarily before the first trial-related activity.
• Patients male and female, aged 18-70
• Been diagnosed with severe oesophageal hypomotility based on Chicago classification 2011
• Must have moderate or severe reflux symptoms and/ or dysphagia, with at least one of these symptoms of moderate severity or worse, and at a minimum average frequency of three days a week during the two weeks prior to the study date
• If the subject is a woman of childbearing potential, she

• must have a negative urine pregnancy test before the start of treatment (minimum β-Human Chorionic Gonadotropin [HCG] sensitivity of 25 mIU/ml), and
• must agree to either use an effective form of birth control (i.e., stabilized on oral contraceptives for at least 1 month or using implanted, transdermal or injected contraceptive hormones, an intra-uterine device, or continuous abstinence from heterosexual sexual contact), or a combination of a barrier method and a spermicidal agent (i.e., cervical cap and spermicidal agent, condom and spermicidal agent, or diaphragm and spermicidal agent),

Exclusion criteria

• Healthy subjects:

• Any incidental abnormal oesophageal motility finding
• History of gastrointestinal symptoms, gastrointestinal tract surgery or other recent abdominal operation within last 3 months.
• Major psychiatric, neurological, respiratory, liver, haemorrhagic and cardiac disorders, malignancies
• Pregnancy and no wheat allergy
• Patients:

• Subjects with a documented history of long segment (>3 cm) Barrett's oesophagus.
• Subjects with documented or suspected large (> 3 cm) hiatus hernia.
• Subjects with fundoplication, endoscopic anti-reflux procedure or major prior GI surgery.
• Subjects with structural abnormalities of oesophagus (ie. Rings and webs, scleroderma)
• Severe oesophageal motility disorders other than oesophageal hypomotility (e.g., achalasia, nutcracker oesophagus).
• Subjects who suffer from frequent vomiting (>1/week)
• Current diagnosis of co-existing psychiatric disease (including alcohol or drug abuse); controlled depression and anxiety are allowed, when treated with at most
• Allergy to prokinetic medicine (AZI), gluten or egg, allergy to latex (reflux monitoring catheter has cross reaction with latex)
• Patients with concomitant prohibited medications, unless willing or able to withdraw from these medications
• Use of prohibited co-medication less than 7 days before the start of the study
• Any condition that, in the opinion of the Investigator, would complicate or compromise the trial (e.g., human immunodeficiency virus [HIV] infection, gastroduodenal ulcer) or the well-being of the subject, or evidence of any clinically relevant pathology that could interfere with trial results or put subject safety at risk.
• Participation in an investigational drug trial in 30 days prior to enrolment.
• Pregnant or breast-feeding subjects.