Clinical trial NCT01257620: Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease
Official title: Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Celiac Disease
Keywords: Inflammatory Bowel Disease
Coeliac Disease
Lead sponsor: Bai, Julio M.D.
Sponsor class: INDIV
Collaborators: name: The National Institute of Probiotics
First posted: 2010-12-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Life parameters (QoL), intestinal permeability and inflammatory markers of patients having positive serological evidences of Celiac Disease.

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, Quality of Life parameters (QoL), intestinal permeability and inflammatory markers of patients having serological evidences of CD (positive serological markers). The testing period will be approximately three weeks between the results of serological testing and before the intestinal biopsy procedure during which time subjects are consuming a gluten-containing diet.

Study Design: A 3-weeks duration, placebo-controlled, double-blind, randomized study plan in ambulatory (non-hospitalized outpatients) patients, with 2 parallel groups. Treatment arms will be as follows:

A). Placebo 2 capsules 3 times daily (morning, evening and night).

B). Probiotics (Bifidobacterium infantis) 2 capsules 3 times per day (morning, evening and night).

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.

Primary outcomes:
measure: Intestinal permeability changes
timeFrame: 21 days
Secondary outcomes:
measure: Changes in the cytokine profile.
timeFrame: 21 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Dr. C. Bonorino Udanondo Gastroenterology Hospital
Study officials:
affiliation: Dr. C. Bonorino Udaondo Gastroenterology Hospital
name: Julio C Bai, M.D.
role: STUDY_DIRECTOR
affiliation: Dr. C. Bonorino Udaondo Gastroenterology Hospital
name: Edgardo Smecuol, M.D.
role: PRINCIPAL_INVESTIGATOR
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