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Pilot Study for the Evaluation of Food Choices in Patients With Inflammatory Bowel Diseases (MICI2021)

I

Institute of Hospitalization and Scientific Care (IRCCS)

Status

Enrolling

Conditions

Inflammatory Bowel Diseases

Study type

Observational

Funder types

Other

Identifiers

NCT05079932
612_2021

Details and patient eligibility

About

This project is a pilot study exploring the effects of dietary choices and quantitative digestion of gluten ingested by individuals with IBD compared to a control population. The aim of the study is to evaluate for the first time in an Italian population of subjects with IBD the presence of a diet based on GFD (gluten free diet).

Full description

Subjects with IBD will be recruited among the patients referred to the IBD clinic of the Policlinico of Milan. These patients are subject to annual check-ups during which, where possible, they will be asked to sign an informed consent. These patients are subjected during the visits of normal clinical follow-up to:

  • Questionnaire on eating habits for the patient with IBD versus control patients;
  • Modified Food Habits Frequency Questionnaire (FFQ), validated for the celiac population. The questionnaire assesses the extent, frequencies of consumption and quantity of gluten-containing foods in a year; this, in order to estimate the average introduction of gluten through the diet versus control patients;
  • Anthropometric and plicometric analysis;
  • Validated clinical activity questionnaires for RCU (ulcerative rectocolitis) and CD (Chron disease) (Mayo Score and Harvey-Bradshaw Index).

Enrollment

45 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age: 18 years
  • Gender: women and men
  • Patients who have been diagnosed with IBD for at least 12 months
  • patients who have signed an informed consent

Exclusion criteria

  • Pregnancy status
  • Patients not suffering from the two main forms of IBD, i.e. CD or RCU (unclassified IBD colitis, collagenous colitis, lymphocytic colitis will be excluded).

Trial contacts and locations

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Central trial contact

Maurizio Vecchi, doctor

Data sourced from clinicaltrials.gov

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