Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT01257620
Eligibility Criteria:
Inclusion Criteria:
* Signing the Informed consent.
* Men or women, 18-75 years old.
* BMI between 18.5 and 35.
* Patients shall have a positive CD-related serology (combined positivity of DGP/tTG Screen plus IgA anti-tTG and or IgA a-DGP tests).
* Patients will abstain from taking medications prohibited by the study from the 7 days prior the enrolment to the end of the trial: NSAIDs, aspirin, lactulose, probiotics and prebiotics in any form of administration (eg. Yogurts or other dairy products)..
* Alcohol consumption is prohibited during the same period.
* Patients should commit to attend on scheduled days, in accordance with the study calendar.
* To be interested in participating the trial
Exclusion Criteria:
* Patients with refractory CD or severe complications thereof, enteropathy-associated T-cell Lymphoma (EATL), ulcerative jejunitis, perforation, severe osteoporosis, malnutrition, among others.
* Individuals with symptoms suggestive of lymphoma or any other serious CD complication taking special care in recently-diagnosed patients, 50 years old or older, in whom EATL must be ruled out by standard methods.
* Individuals with other active chronic GI pathologies like Crohn's disease, ulcerative colitis and irritable bowel syndrome, microscopic colitis, and lactose intolerance.
* Patients with Type 1 or Type 2 diabetes or other autoimmune diseases, such as autoimmune hepatitis and primary biliary cirrhosis.
* Individuals with co-morbidities whose participation, in the investigator's judgment, would be inadvisable; for instance, unstable clinical conditions such as chronic obstructive pulmonary disease, angina pectoris, severe cardio-respiratory conditions, etc.
* Individuals with symptomatic neurological or psychiatric conditions that could potentially interfere with the study.
* Individuals with a clinical severity requiring immediate treatment at the consideration of the investigator.
* Patients with hemoglobin levels less than 8.5 g/dL or who had donated blood in the last 56 days or donated a unit of plasma in the last 7 days.
* Patients with a history of alcohol or drug abuse in the prior 2 years.
* Individuals taking "prohibited" medications in relation to the study (see point 6, previous section).
* Individuals with a history of neoplasia.
* Individuals participating in another clinical study that either involves medications or concluded during the last 30 days.
* Individuals previously exposed to Bifidobacteria species.
* Subjects not willing to maintain a gluten-containing diet during the 3-weeks period of the trial
* Pregnant women.
* Allergies to goat milk; no recent or planned dietary changes, esp. regarding gluten intake.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01257620
Study Brief:
Protocol Section:
NCT01257620