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

This study has been completed.
Sponsor:
Collaborator:
The National Institute of Probiotics
Information provided by (Responsible Party):
Bai, Julio M.D., Dr. C. Bonorino Udaondo Gastroenterology Hospital
ClinicalTrials.gov Identifier:
NCT01257620
First received: December 8, 2010
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Celiac Disease
Dietary Supplement: Probiotic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease

Resource links provided by NLM:


Further study details as provided by Bai, Julio M.D.:

Primary Outcome Measures:
  • Intestinal permeability changes [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 22
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Dietary Supplement: Probiotic
Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.
Other Names:
  • Natren Inc.
  • Life Start Two
  • Bifidobacterium infantis
Experimental: Probiotic
Life Start Two
Dietary Supplement: Probiotic
Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.
Other Names:
  • Natren Inc.
  • Life Start Two
  • Bifidobacterium infantis

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257620

Locations
Argentina
Dr. C. Bonorino Udanondo Gastroenterology Hospital
Buenos Aires, Argentina
Sponsors and Collaborators
Bai, Julio M.D.
The National Institute of Probiotics
Investigators
Study Director: Julio C Bai, M.D. Dr. C. Bonorino Udaondo Gastroenterology Hospital
Principal Investigator: Edgardo Smecuol, M.D. Dr. C. Bonorino Udaondo Gastroenterology Hospital
  More Information

Publications:
De Palma G, Nadal I, Medina M, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y.Intestinal dysbiosis and reduced immunoglobulin-coated bacteria associated with coeliac disease in children. BMC Microbiol 2010;10:63.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bai, Julio M.D., Principle Investigator, Dr. C. Bonorino Udaondo Gastroenterology Hospital
ClinicalTrials.gov Identifier: NCT01257620     History of Changes
Other Study ID Numbers: Celiac
Study First Received: December 8, 2010
Last Updated: February 10, 2012
Health Authority: Argentina: Ministry of Health

Keywords provided by Bai, Julio M.D.:
Inflammatory Bowel Disease
Coeliac Disease

Additional relevant MeSH terms:
Celiac Disease
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 16, 2014