Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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).
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Luca Elli, PhD|
|Principal Investigator Affiliation||Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Inflammatory Bowel Diseases|
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.
- - Anthropometric and plicometric analysis; - Validated clinical activity questionnaires for RCU (ulcerative rectocolitis) and CD (Chron disease) (Mayo Score and Harvey-Bradshaw Index).
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.