Status:
COMPLETED
Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease
Lead Sponsor:
Bai, Julio M.D.
Collaborating Sponsors:
The National Institute of Probiotics
Conditions:
Celiac Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This exploratory study has been designed to determine the effect of the probiotic Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical features, Quality of Lif...
Detailed Description
Objective: This exploratory study has been designed to determine the effect of the probiotic Bifidobacterium infantis vs. placebo orally administered over a period of 3 weeks on clinical features, Qua...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01257620
Start Date
December 1 2010
End Date
December 1 2011
Last Update
February 13 2012
Active Locations (1)
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1
Dr. C. Bonorino Udanondo Gastroenterology Hospital
Buenos Aires, Argentina