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Inflammatory Bowel DiseasesMICI2021NCT05079932

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

An observational study of Inflammatory Bowel Diseases, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Inflammatory Bowel Diseases
How many people
45 participants
Where
1 siteItaly
Study dates
1 Apr 2021to 31 May 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 30 patients with IBD (15 CD and 15 RCU) and 15 patients from the control population

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Maurizio Vecchi, doctor contact

0255033418

maurizio.vecchi@policlinico.it

Italy1 site, 1 recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano

    Milan, 20122

    Recruiting

Other trials in Italy

About this study

Official title: Pilot Study for the Evaluation of Food Choices and Exclusion of Gluten From the Diet in Patients With Inflammatory Bowel Diseases

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).

Read the detailed 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).
Keywords
Ulcerative rectocolitis, Crohn Disease, Gluten-free diet, IBD, Nutrition
Medical subject headings
Inflammatory Bowel Diseases, Proctocolitis, Crohn Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dietary habits in IBD patients

    Quantification of gluten intake by IBD patients compared with the control population.

    Evaluation of foods excluded from the diet of IBD patients.

    Measured: April 2021- April 2023

Secondary outcomes (4)

  1. Assessment of weight

    Assessment of weight (kilograms) in IBD patients

    Measured: April 2021- April 2023

  2. Assessment of height

    Assessment of height (meters) in IBD patients

    Measured: April 2021- April 2023

  3. Assessment of clinical disease activity

    Evaluation of validated clinical activity indices for RCU in IBD patients (Mayo Score)

    Measured: April 2021- April 2023

  4. Assessment of clinical disease activity

    Evaluation of validated clinical activity indices for CD in IBD patients (Harvey-Bradshaw Index)

    Measured: April 2021- April 2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2021
  2. Study start1 Apr 2021
  3. Primary completion1 Apr 2023 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05079932
Sponsor's protocol ID
612_2021
Acronym
MICI2021
Status last verified
Oct 2021
First submitted
23 Sep 2021
Last updated
15 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Weaver KN, Herfarth H. Gluten-Free Diet in IBD: Time for a Recommendation? Mol Nutr Food Res. 2021 Mar;65(5):e1901274. doi: 10.1002/mnfr.201901274. Epub 2020 Jun 28.

    PubMed 32558265

  • Mazzeo T, Roncoroni L, Lombardo V, Tomba C, Elli L, Sieri S, Grioni S, Bardella MT, Agostoni C, Doneda L, Brighenti F, Pellegrini N. Evaluation of a Modified Italian European Prospective Investigation into Cancer and Nutrition Food Frequency Questionnaire for Individuals with Celiac Disease. J Acad Nutr Diet. 2016 Nov;116(11):1810-1816. doi: 10.1016/j.jand.2016.04.013. Epub 2016 May 28.

    PubMed 27245762

  • Schroeder KW, Tremaine WJ, Ilstrup DM. Coated oral 5-aminosalicylic acid therapy for mildly to moderately active ulcerative colitis. A randomized study. N Engl J Med. 1987 Dec 24;317(26):1625-9. doi: 10.1056/NEJM198712243172603.

    PubMed 3317057

  • Dhanda AD, Creed TJ, Greenwood R, Sands BE, Probert CS. Can endoscopy be avoided in the assessment of ulcerative colitis in clinical trials? Inflamm Bowel Dis. 2012 Nov;18(11):2056-62. doi: 10.1002/ibd.22879. Epub 2012 Jan 23.

    PubMed 22271464

  • Harvey RF, Bradshaw JM. A simple index of Crohn's-disease activity. Lancet. 1980 Mar 8;1(8167):514. doi: 10.1016/s0140-6736(80)92767-1. No abstract available.

    PubMed 6102236

  • Elli L, Bascunan K, di Lernia L, Bardella MT, Doneda L, Soldati L, Orlando S, Ferretti F, Lombardo V, Barigelletti G, Scricciolo A, Fabiano S, Vecchi M, Roncoroni L. Safety of occasional ingestion of gluten in patients with celiac disease: a real-life study. BMC Med. 2020 Mar 16;18(1):42. doi: 10.1186/s12916-020-1511-6.

    PubMed 32172690

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Diseases, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maurizio Vecchi, doctor (0255033418, maurizio.vecchi@policlinico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dietary habits in IBD patients (time frame: April 2021- April 2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05079932, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.

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