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Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease (Celiac)

Primary Purpose

Celiac Disease

Status

Completed

Phase

Not Applicable

Locations

Argentina

Study Type

Interventional

Intervention

Probiotic

About this trial

This is an interventional treatment trial for Celiac Disease focused on measuring Inflammatory Bowel Disease, Coeliac Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dr. C. Bonorino Udanondo Gastroenterology Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Probiotic

Arm Description

Placebo

Life Start Two

Outcomes

Primary Outcome Measures

Intestinal permeability changes

Subjects will come to the laboratory after an overnight fast, ingest the sugar probes, and collect all urine passed over the ensuing 24 hours into a pre-weighed container with 5 ml of 10% thymol in isopropanol. Urine will be vigorously mixed, total volume recorded, and aliquots rapidly frozen for subsequent transport and analysis. To evaluate intestinal permeability, subjects will ingest a solution containing: 5 g lactulose (Technilab, Montreal, Quebec, Canada), and 2 g mannitol (Sigma, St Louis, Missouri, USA) in 450 ml of water (osmolality approximately 1800 mOsmol/l).

Secondary Outcome Measures

Changes in the cytokine profile.

Mononuclear cells obtained from blood will be isolated by Ficoll-Hypaque density centrifugation and resuspended in complete media/Dulbecco's modified Eagle medium. These mononuclear cells will be termed peripheral blood mononuclear cells (PBMCs). PBMCs will be incubated, nonstimulated, for 72 hours at 37°C in a 5% CO2 humidified atmosphere. Nonstimulated PBMC cytokine reflects the cytokine milieu from wich the PBMCs were originally isolated. Interleukin(IL)-10 and IL-12p40 cytokine levels will be measured using enzyme-linked immunosorbent assays.

Full Information

NCT ID

NCT01257620

First Posted

December 8, 2010

Last Updated

February 10, 2012

Sponsor

Bai, Julio M.D.

Collaborators

The National Institute of Probiotics

1. Study Identification

Unique Protocol Identification Number

NCT01257620

Brief Title

Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease

Acronym

Celiac

Official Title

Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

December 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Bai, Julio M.D.

Collaborators

The National Institute of Probiotics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Celiac Disease

Keywords

Inflammatory Bowel Disease, Coeliac Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Probiotic

Arm Type

Experimental

Arm Description

Life Start Two

Intervention Type

Dietary Supplement

Intervention Name(s)

Probiotic

Other Intervention Name(s)

Natren Inc., Life Start Two, Bifidobacterium infantis

Intervention Description

Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.

Primary Outcome Measure Information:

Title

Intestinal permeability changes

Description

Time Frame

21 days

Secondary Outcome Measure Information:

Title

Changes in the cytokine profile.

Description

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julio C Bai, M.D.

Organizational Affiliation

Dr. C. Bonorino Udaondo Gastroenterology Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Edgardo Smecuol, M.D.

Organizational Affiliation

Dr. C. Bonorino Udaondo Gastroenterology Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dr. C. Bonorino Udanondo Gastroenterology Hospital

City

Buenos Aires

Country

Argentina

12. IPD Sharing Statement

Citations:

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16099460

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Clinical Trial on the Effects of Bifidobacterium Infantis in Active Celiac Disease

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