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Evaluate the Effect of Diet on Gastrointestinal Adverse Events in Patients With IPF Treated With Pirfenidone

NCT03539289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-07-16

No results posted yet for this study

Summary

The primary objective is to compare the incidence of gastrointestinal AEs in patients treated with IPF, initiating pirfenidone for the first time, according to the type of diet (MUFA vs SFA). Gastrointestinal AEs rates between study groups will be evaluated during the first 16 weeks of pirfenidone treatment.

Conditions

  • Pulmonary Disease

Interventions

BEHAVIORAL

MUFA Diet

Control of patient MUFA Diet

BEHAVIORAL

SFA Diet

Control of patient SFA Diet

Sponsors & Collaborators

  • Institut d'Investigació Biomèdica de Bellvitge

    collaborator OTHER

  • Hospital Universitari de Bellvitge

    collaborator OTHER

  • Consorcio Centro de Investigación Biomédica en Red (CIBER)

    lead OTHER_GOV

Principal Investigators

  • María Molina Molina · Unidad Funcional de Intersticio Pulmonar (UFIP).Servicio de Neumología. Hospital Universitario de Bellvitge

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2020-04-22
Completion
2020-04-22

Countries

  • Germany
  • Greece
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03539289 on ClinicalTrials.gov