MADIET (version 1.6)
Research type
Research Study
Full title
AN OPEN LABEL PHASE IV, MULTICENTER, INTERNATIONAL, INTERVENTIONAL STUDY TO EVALUATE THE EFFECT OF DIET ON GASTROINTESTINAL ADVERSE EVENTS IN PATIENTS WITH IPF TREATED WITH PIRFENIDONE
IRAS ID
245949
Contact name
Elizabeth Renzoni
Contact email
Sponsor organisation
CIBER - Instituto Carlos III
Eudract number
2016-003827-45
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Pirfenidone is a treatment for idiopathic pulmonary fibrosis (IPF). Through earlier records of patients receiving this treatment, certain variability between countries or regions has been observed in the appearance of gastrointestinal discomfort. This variability could be related to the differences in the patients' regular diet, namely the differences in the quantity and type of fats regularly consumed. That is why we want to perform this study with patients who follow one or another type of diet: either the southern European with predominance of monounsaturated fats, or the northern European with predominance of saturated fats.
The purpose of the study is to determine the influence that the patient's diet can have on the development or presence of gastrointestinal discomfort or symptoms in patients treated for IPF with pirfenidone.
This study is expected to include 90 patients in 6 centres distributed in 6 countries: 3 centres in southern Europe (Spain, Italy and Greece) and 3 centres in northern Europe (the Netherlands, the United Kingdom and Germany).REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0205
Date of REC Opinion
15 May 2018
REC opinion
Further Information Favourable Opinion