Non-Alcoholic Fatty Liver Disease (NAFLD) in Constipated Patients
Conditions
Interventions
Placebo
Lubiprostone 12 mcg group
Lubiprostone 24 mcg group
Sponsors
Yokohama University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients aged between 20 years and 85 years (both inclusive) at the time of informed consent 2)Patients with NAFLD which did not respond to 3-month diet and exercise therapy 3)Patients with constipation in the past or now (diagnostic criteria: Rome4) 4)Patients who are able to provide written consent to participate in this research in person, follow instructions during participation in this research, and undergo protocol-specified physical examination and other examinations, and report symptoms or events 5)Patients with a diagnosis of fatty liver based on abdominal ultrasonography 6)Patients with S1, S2, S3 fatty liver or equivalent on TE (using FibroScan) or MRI/MRS 7)Patients with F1, F2, or F3 fibrosis or equivalent on TE (FibroScan) or MRE 8)Patients with an ALT level of more than 40 IU/L at the start of this study 9)Patients with no habitual alcohol consumption (i.e., consumption of ethanol less than 30 g/day in men and less than 20 g/day in women)
Exclusion criteria
Exclusion criteria: 1)Patients with any change to their oral medications within 3 months before informed consent 2)Patients with any contraindications listed on the package insert for lubiprostone or with a history of hypersensitivity to any ingredients of lubiprostone 3)Patients with any other concurrent liver disease, such as hepatitis C, hepatitis B, or autoimmune hepatitis 4)Patients with concurrent or past history of any serious cardiac, vascular, hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatry disease 5)Patients with drug-induced, symptomatic NAFLD 6)Patients who participated in any other clinical study and received study treatment within 1 month before the start of this research (counted from the first day of study medication) 7)Patients with diabetes mellitus being treated with insulin injections 8)Patients with a history of abdominal or gastrointestinal surgery, with the exception of appendicitis 9)Breastfeeding women, or women with possible pregnancy 10)Other patients who are inappropriate as participants in this research in the opinion of the principal investigator etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in ALT at Week 12 | — |
Countries
Japan
Contacts
Public ContactTakaomi Kessoku
Yokohama University School of Medicine Gastroenterology and Hepatology
Outcome results
None listed