Celiac DiseaseCeliacNCT01257620

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

A study testing Probiotic in people with Celiac Disease, run by Bai, Julio M.D. at 1 site in Argentina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Celiac Disease
What is being tested?: Probiotic
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteArgentina
Study dates: Dec 2010to Dec 2011
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Argentina1 site

Dr. C. Bonorino Udanondo Gastroenterology Hospital
Buenos Aires

Other trials in Argentina

About this study

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

Read the 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).

Conditions: Celiac Disease
Being tested: Probiotic
Keywords: Inflammatory Bowel Disease, Coeliac Disease
Medical subject headings: Celiac Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ProbioticDietary supplement
Also called Natren Inc., Life Start Two, Bifidobacterium infantis
Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.

Study groups in NCT01257620
Study group	Role	What they receive
Placebo	Placebo comparator	Placebo Receives: Dietary Supplement: Probiotic
Probiotic	Experimental	Life Start Two Receives: Dietary Supplement: Probiotic

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 21 days

Secondary outcomes (1)

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.
Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2010Dec 2011

First posted10 Dec 2010 (estimated)
Study startDec 2010
Primary completionSep 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for Celiac DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01257620
Sponsor's protocol ID: Celiac
Acronym: Celiac
Status last verified: Feb 2012
First submitted: 8 Dec 2010
Last updated: 13 Feb 2012
Results posted: No
Data monitoring committee: Yes

Publications

Sander GR, Cummins AG, Henshall T, Powell BC. Rapid disruption of intestinal barrier function by gliadin involves altered expression of apical junctional proteins. FEBS Lett. 2005 Aug 29;579(21):4851-5. doi: 10.1016/j.febslet.2005.07.066.
PubMed 16099460
Maiuri L, Ciacci C, Ricciardelli I, Vacca L, Raia V, Rispo A, Griffin M, Issekutz T, Quaratino S, Londei M. Unexpected role of surface transglutaminase type II in celiac disease. Gastroenterology. 2005 Nov;129(5):1400-13. doi: 10.1053/j.gastro.2005.07.054.
PubMed 16285941
Barone MV, Gimigliano A, Castoria G, Paolella G, Maurano F, Paparo F, Maglio M, Mineo A, Miele E, Nanayakkara M, Troncone R, Auricchio S. Growth factor-like activity of gliadin, an alimentary protein: implications for coeliac disease. Gut. 2007 Apr;56(4):480-8. doi: 10.1136/gut.2005.086637. Epub 2006 Aug 4.
PubMed 16891357
Rollan G, De Angelis M, Gobbetti M, de Valdez GF. Proteolytic activity and reduction of gliadin-like fractions by sourdough lactobacilli. J Appl Microbiol. 2005;99(6):1495-502. doi: 10.1111/j.1365-2672.2005.02730.x.
PubMed 16313422
Di Cagno R, De Angelis M, Lavermicocca P, De Vincenzi M, Giovannini C, Faccia M, Gobbetti M. Proteolysis by sourdough lactic acid bacteria: effects on wheat flour protein fractions and gliadin peptides involved in human cereal intolerance. Appl Environ Microbiol. 2002 Feb;68(2):623-33. doi: 10.1128/AEM.68.2.623-633.2002.
PubMed 11823200
Di Cagno R, De Angelis M, Auricchio S, Greco L, Clarke C, De Vincenzi M, Giovannini C, D'Archivio M, Landolfo F, Parrilli G, Minervini F, Arendt E, Gobbetti M. Sourdough bread made from wheat and nontoxic flours and started with selected lactobacilli is tolerated in celiac sprue patients. Appl Environ Microbiol. 2004 Feb;70(2):1088-96. doi: 10.1128/AEM.70.2.1088-1096.2004.
PubMed 14766592
Gerez CL, Rollan GC, de Valdez GF. Gluten breakdown by lactobacilli and pediococci strains isolated from sourdough. Lett Appl Microbiol. 2006 May;42(5):459-64. doi: 10.1111/j.1472-765X.2006.01889.x.
PubMed 16620203
Rizzello CG, De Angelis M, Di Cagno R, Camarca A, Silano M, Losito I, De Vincenzi M, De Bari MD, Palmisano F, Maurano F, Gianfrani C, Gobbetti M. Highly efficient gluten degradation by lactobacilli and fungal proteases during food processing: new perspectives for celiac disease. Appl Environ Microbiol. 2007 Jul;73(14):4499-507. doi: 10.1128/AEM.00260-07. Epub 2007 May 18.
PubMed 17513580
Lindfors K, Blomqvist T, Juuti-Uusitalo K, Stenman S, Venalainen J, Maki M, Kaukinen K. Live probiotic Bifidobacterium lactis bacteria inhibit the toxic effects induced by wheat gliadin in epithelial cell culture. Clin Exp Immunol. 2008 Jun;152(3):552-8. doi: 10.1111/j.1365-2249.2008.03635.x. Epub 2008 Apr 16.
PubMed 18422736
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 Feb 24;10:63. doi: 10.1186/1471-2180-10-63.
PubMed 20181275
De Palma G, Cinova J, Stepankova R, Tuckova L, Sanz Y. Pivotal Advance: Bifidobacteria and Gram-negative bacteria differentially influence immune responses in the proinflammatory milieu of celiac disease. J Leukoc Biol. 2010 May;87(5):765-78. doi: 10.1189/jlb.0709471. Epub 2009 Dec 10.
PubMed 20007908
Di Cagno R, Rizzello CG, Gagliardi F, Ricciuti P, Ndagijimana M, Francavilla R, Guerzoni ME, Crecchio C, Gobbetti M, De Angelis M. Different fecal microbiotas and volatile organic compounds in treated and untreated children with celiac disease. Appl Environ Microbiol. 2009 Jun;75(12):3963-71. doi: 10.1128/AEM.02793-08. Epub 2009 Apr 17.
PubMed 19376912
Collado MC, Donat E, Ribes-Koninckx C, Calabuig M, Sanz Y. Imbalances in faecal and duodenal Bifidobacterium species composition in active and non-active coeliac disease. BMC Microbiol. 2008 Dec 22;8:232. doi: 10.1186/1471-2180-8-232.
PubMed 19102766
Medina M, De Palma G, Ribes-Koninckx C, Calabuig M, Sanz Y. Bifidobacterium strains suppress in vitro the pro-inflammatory milieu triggered by the large intestinal microbiota of coeliac patients. J Inflamm (Lond). 2008 Nov 3;5:19. doi: 10.1186/1476-9255-5-19.
PubMed 18980693
Nadal I, Donant E, Ribes-Koninckx C, Calabuig M, Sanz Y. Imbalance in the composition of the duodenal microbiota of children with coeliac disease. J Med Microbiol. 2007 Dec;56(Pt 12):1669-1674. doi: 10.1099/jmm.0.47410-0.
PubMed 18033837

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploratory, Randomized, Double-blind, Placebo-Controlled Study on the Effects of Bifidobacterium Infantis in Active Celiac Disease
ClinicalTrials.gov ID: NCT01257620
Acronym / sponsor ID: Celiac / Celiac
Conditions: Celiac Disease
Keywords: Inflammatory Bowel Disease, Coeliac Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Bai, Julio M.D.
Collaborators: The National Institute of Probiotics
Study start: Dec 2010
Primary completion: Sep 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 10 Dec 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Dietary Supplement: ProbioticPlacebo
Probiotic	Experimental	Dietary Supplement: ProbioticLife Start Two

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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)..

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ProbioticAlso: Natren Inc., Life Start Two, Bifidobacterium infantisBifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.	Dietary supplement	Placebo, Probiotic

Primary outcome

Intestinal permeability changes
Time frame: 21 days
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).

1 secondary outcome

Changes in the cytokine profile.
Time frame: 21 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
Background: PubMed 16099460Sander GR, Cummins AG, Henshall T, Powell BC. Rapid disruption of intestinal barrier function by gliadin involves altered expression of apical junctional proteins. FEBS Lett. 2005 Aug 29;579(21):4851-5. doi: 10.1016/j.febslet.2005.07.066.
Background: PubMed 16285941Maiuri L, Ciacci C, Ricciardelli I, Vacca L, Raia V, Rispo A, Griffin M, Issekutz T, Quaratino S, Londei M. Unexpected role of surface transglutaminase type II in celiac disease. Gastroenterology. 2005 Nov;129(5):1400-13. doi: 10.1053/j.gastro.2005.07.054.
Background: PubMed 16891357Barone MV, Gimigliano A, Castoria G, Paolella G, Maurano F, Paparo F, Maglio M, Mineo A, Miele E, Nanayakkara M, Troncone R, Auricchio S. Growth factor-like activity of gliadin, an alimentary protein: implications for coeliac disease. Gut. 2007 Apr;56(4):480-8. doi: 10.1136/gut.2005.086637. Epub 2006 Aug 4.
Background: PubMed 16313422Rollan G, De Angelis M, Gobbetti M, de Valdez GF. Proteolytic activity and reduction of gliadin-like fractions by sourdough lactobacilli. J Appl Microbiol. 2005;99(6):1495-502. doi: 10.1111/j.1365-2672.2005.02730.x.
Background: PubMed 11823200Di Cagno R, De Angelis M, Lavermicocca P, De Vincenzi M, Giovannini C, Faccia M, Gobbetti M. Proteolysis by sourdough lactic acid bacteria: effects on wheat flour protein fractions and gliadin peptides involved in human cereal intolerance. Appl Environ Microbiol. 2002 Feb;68(2):623-33. doi: 10.1128/AEM.68.2.623-633.2002.
Background: PubMed 14766592Di Cagno R, De Angelis M, Auricchio S, Greco L, Clarke C, De Vincenzi M, Giovannini C, D'Archivio M, Landolfo F, Parrilli G, Minervini F, Arendt E, Gobbetti M. Sourdough bread made from wheat and nontoxic flours and started with selected lactobacilli is tolerated in celiac sprue patients. Appl Environ Microbiol. 2004 Feb;70(2):1088-96. doi: 10.1128/AEM.70.2.1088-1096.2004.
Background: PubMed 16620203Gerez CL, Rollan GC, de Valdez GF. Gluten breakdown by lactobacilli and pediococci strains isolated from sourdough. Lett Appl Microbiol. 2006 May;42(5):459-64. doi: 10.1111/j.1472-765X.2006.01889.x.
Background: PubMed 17513580Rizzello CG, De Angelis M, Di Cagno R, Camarca A, Silano M, Losito I, De Vincenzi M, De Bari MD, Palmisano F, Maurano F, Gianfrani C, Gobbetti M. Highly efficient gluten degradation by lactobacilli and fungal proteases during food processing: new perspectives for celiac disease. Appl Environ Microbiol. 2007 Jul;73(14):4499-507. doi: 10.1128/AEM.00260-07. Epub 2007 May 18.
Background: PubMed 18422736Lindfors K, Blomqvist T, Juuti-Uusitalo K, Stenman S, Venalainen J, Maki M, Kaukinen K. Live probiotic Bifidobacterium lactis bacteria inhibit the toxic effects induced by wheat gliadin in epithelial cell culture. Clin Exp Immunol. 2008 Jun;152(3):552-8. doi: 10.1111/j.1365-2249.2008.03635.x. Epub 2008 Apr 16.
Background: PubMed 20181275De 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 Feb 24;10:63. doi: 10.1186/1471-2180-10-63.
Background: PubMed 20007908De Palma G, Cinova J, Stepankova R, Tuckova L, Sanz Y. Pivotal Advance: Bifidobacteria and Gram-negative bacteria differentially influence immune responses in the proinflammatory milieu of celiac disease. J Leukoc Biol. 2010 May;87(5):765-78. doi: 10.1189/jlb.0709471. Epub 2009 Dec 10.
Background: PubMed 19376912Di Cagno R, Rizzello CG, Gagliardi F, Ricciuti P, Ndagijimana M, Francavilla R, Guerzoni ME, Crecchio C, Gobbetti M, De Angelis M. Different fecal microbiotas and volatile organic compounds in treated and untreated children with celiac disease. Appl Environ Microbiol. 2009 Jun;75(12):3963-71. doi: 10.1128/AEM.02793-08. Epub 2009 Apr 17.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Julio C Bai, M.D. study director

Dr. C. Bonorino Udaondo Gastroenterology Hospital

Edgardo Smecuol, M.D. principal investigator

Dr. C. Bonorino Udaondo Gastroenterology Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic in people with Celiac Disease, run by Bai, Julio M.D. at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intestinal permeability changes (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01257620, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2012.