Feeding ToleranceNCT01788761
The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants
A study testing Probiotic Supplemented Group in people with Feeding Tolerance, run by Mercy Health System at 1 site in United States.
Trial summary
This is a research study that will look at the effects of giving two nutritional supplements on extremely low birth infants (infants weighing less than 1000 grams or weighing less than approximately 2 lbs 3 1/2 ounces at birth). Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Feeding Tolerance
- What is being tested?
- Probiotic Supplemented Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 133 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 11 Jul 2018
- 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 Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight between 500-999 grams
- Apgar score greater than or equal to 3 at 5 minutes
- Infant free from any known major congenital anomalies or chromosomal/genetic anomalies
- Infant without any known cyanotic or complex congenital heart disease
- Infant NPO or on trophic enteral feedings than have been started less than 24 hours previously
- Infant without prior history of necrotizing enterocolitis or gastrointestinal perforation
Show all 11Show fewer
- Infant without previous exposure to probiotics
- Infant that will be ready to start trophic feedings within the first 14 days of life
- Infant less than or equal to 14 days of age
- Infant born to HIV negative mother
- Written informed consent obtained from mother
Who cannot join
- Infant born to HIV positive mother
- Infant with history of prior probiotic exposure
- Infant greater than 14 days of age
- Infant on enteral feedings for greater than 24 hours
- Infant with major congenital anomaly/chromosomal or genetic anomaly
- Infant with cyanotic/complex congenital heart disease
- Infant with previous gastrointestinal perforation/necrotizing enterocolitis
- 5 minute Apgar score < 3
Trial locations and contacts
1 site in 1 country.
United States1 site
Rockford Memorial Hospital
Rockford, Illinois, 61103
About this study
This is a research study that will look at the effects of giving two nutritional supplements on extremely low birth infants (infants weighing less than 1000 grams or weighing less than approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each contain a different probiotic. In this study the investigators will mainly be looking at the effect that these supplements may have on how well babies tolerate their feedings and how long they require supplemental intravenous fluids for nutritional support. The investigators will also, however, look at many other factors such as rate of growth, rates of infection, survival rate and the length of time the infant needs to be in the hospital. The investigators will also look at its effect on conditions/complications of prematurity such as bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of the infant's intestines), retinopathy of prematurity (eye disease associated with prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus (a blood vessel connecting two main blood vessels coming out of the heart that does not close spontaneously (by itself).
Read the detailed description
The purpose of this research study is to investigate the effect of the administration of the nutritional supplements, Culturelle for Kids/Kids Culturelle in combination with Align, containing the Probiotics Lactobacillus GG and Bifidobacterium Infantis, on feeding tolerance (as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings) in high risk extremely low birth weight infants.
- Conditions
- Feeding Tolerance
- Being tested
- Probiotic Supplemented Group, Control Group
- Keywords
- Probiotics, Feeding Tolerance, Extremely Low Birthweight Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Supplemented GroupDietary supplement
Also called Culture for Kids, Kids Culturelle, Align, Lactobacillus GG
Control GroupDietary supplement
Also called Breastmilk, Formula
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Supplemented Group | Experimental | 500,000,0000 cells of Lactobacillus GG (utilizing either Culturelle for Kids or Kids Culturelle preparation) and 500,000,000 cells of Bifidobacterium Infantis (utilizing Align capsule) diluted in 3 ml breastmilk/formula and administered enterally from first day of enteral feeds until term gestation/discharge/transfer/death (whichever occurs first) every day infant is receives enteral feedings Receives: Dietary Supplement: Probiotic Supplemented Group |
| Control Group | Sham comparator | 3 ml enteral feeding of breastmilk/formula administered once daily in addition to regularly prescribed enteral feedings from day of first feeding until term gestation/discharge/transfer/death (which ever occurs first) and administered every day that infant receives enteral feedings Receives: Dietary Supplement: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeding Tolerance
Feeding Tolerance as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings
Measured: Evaluated on a daily basis until hospital discharge/transfer/death up until one year of age
Secondary outcomes (9)
Necrotizing Enterocolitis (Bell's Stage 2 or greater)
Measured: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until 1 year of age
Culture proven sepsis without Necrotizing Enterocolitis
Measured: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Chronic Lung Disease
Measured: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Periventricular Leukomalacia
Measured: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Mortality
Measured: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Intraventricular Hemorrhage
Measured: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Daily weight gain in grams
Measured: Measured daily until time of hospital discharge/transfer/death up until one year of age
Discharge weight measured and expressed by percentile of growth for age
Measured: Assessed at the time of discharge/transfer/death up until one year of age
Length of Stay
Measured: Measured at time of discharge/transfer/death up until one year of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJul 2012
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Feeding ToleranceStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Health System
- Sponsor type
- Research network
- Collaborators
- Rockford Memorial Hospital Development Foundation
- Responsible party
- Sponsor
- Investigators
- Kim M Schmidt, MS, APN, NNP, Principal investigator, Mercy Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788761
- Sponsor's protocol ID
- pROBIOTICS11
- Status last verified
- Apr 2017
- First submitted
- 4 Feb 2013
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Alfaleh K, Anabrees J, Bassler D. Probiotics reduce the risk of necrotizing enterocolitis in preterm infants: a meta-analysis. Neonatology. 2010;97(2):93-9. doi: 10.1159/000235684. Epub 2009 Aug 25.
PubMed 19707025Amerifit Inc. Culturelle Probiotics for Kids. Packaging information 2010
Baldassarre ME, Laforgia N, Fanelli M, Laneve A, Grosso R, Lifschitz C. Lactobacillus GG improves recovery in infants with blood in the stools and presumptive allergic colitis compared with extensively hydrolyzed formula alone. J Pediatr. 2010 Mar;156(3):397-401. doi: 10.1016/j.jpeds.2009.09.012. Epub 2009 Nov 2.
PubMed 19880141Bin-Nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Caplan M, Hammerman C. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005 Aug;147(2):192-6. doi: 10.1016/j.jpeds.2005.03.054.
PubMed 16126048Chou IC, Kuo HT, Chang JS, Wu SF, Chiu HY, Su BH, Lin HC. Lack of effects of oral probiotics on growth and neurodevelopmental outcomes in preterm very low birth weight infants. J Pediatr. 2010 Mar;156(3):393-6. doi: 10.1016/j.jpeds.2009.09.051. Epub 2009 Nov 14.
PubMed 19914635Dani C, Biadaioli R, Bertini G, Martelli E, Rubaltelli FF. Probiotics feeding in prevention of urinary tract infection, bacterial sepsis and necrotizing enterocolitis in preterm infants. A prospective double-blind study. Biol Neonate. 2002 Aug;82(2):103-8. doi: 10.1159/000063096.
PubMed 12169832Deshpande G, Rao S, Patole S, Bulsara M. Updated meta-analysis of probiotics for preventing necrotizing enterocolitis in preterm neonates. Pediatrics. 2010 May;125(5):921-30. doi: 10.1542/peds.2009-1301. Epub 2010 Apr 19.
PubMed 20403939Guenther K, Straube E, Pfister W, Guenther A, Huebler A. Sever sepsis after probiotic treatment with Escherichia coli NISSLE 1917. Pediatr Infect Dis J. 2010 Feb;29(2):188-9. doi: 10.1097/INF.0b013e3181c36eb9. No abstract available.
PubMed 20118747Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. Effects of probiotic and prebiotic on gastrointestinal motility in newborns. J Physiol Pharmacol. 2009 Dec;60 Suppl 6:27-31.
PubMed 20224148Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
PubMed 20403940Kuitunen M, Kukkonen K, Savilahti E. Pro- and prebiotic supplementation induces a transient reduction in hemoglobin concentration in infants. J Pediatr Gastroenterol Nutr. 2009 Nov;49(5):626-30. doi: 10.1097/MPG.0b013e31819de849.
PubMed 19644396Ladd N, Ngo T. The use of probiotics in the prevention of necrotizing enterocolitis in preterm infants. Proc (Bayl Univ Med Cent). 2009 Jul;22(3):287-91. doi: 10.1080/08998280.2009.11928535. No abstract available.
PubMed 21240300Lin HC, Su BH, Chen AC, Lin TW, Tsai CH, Yeh TF, Oh W. Oral probiotics reduce the incidence and severity of necrotizing enterocolitis in very low birth weight infants. Pediatrics. 2005 Jan;115(1):1-4. doi: 10.1542/peds.2004-1463.
PubMed 15629973Lin HC, Hsu CH, Chen HL, Chung MY, Hsu JF, Lien RI, Tsao LY, Chen CH, Su BH. Oral probiotics prevent necrotizing enterocolitis in very low birth weight preterm infants: a multicenter, randomized, controlled trial. Pediatrics. 2008 Oct;122(4):693-700. doi: 10.1542/peds.2007-3007.
PubMed 18829790Luoto R, Isolauri E, Lehtonen L. Safety of Lactobacillus GG probiotic in infants with very low birth weight: twelve years of experience. Clin Infect Dis. 2010 May 1;50(9):1327-8. doi: 10.1086/651694. No abstract available.
PubMed 20367236
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants
- ClinicalTrials.gov ID
- NCT01788761
- Acronym / sponsor ID
- pROBIOTICS11
- Conditions
- Feeding Tolerance
- Keywords
- Probiotics, Feeding Tolerance, Extremely Low Birthweight Infants
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Mercy Health SystemResearch network
- Collaborators
- Rockford Memorial Hospital Development Foundation
- Study start
- Jul 2012
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 11 Feb 2013 (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.
This is a research study that will look at the effects of giving two nutritional supplements on extremely low birth infants (infants weighing less than 1000 grams or weighing less than approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each contain a different probiotic. In this study the investigators will mainly be looking at the effect that these supplements may have on how well babies tolerate their feedings and how long they require supplemental intravenous fluids for nutritional support. The investigators will also, however, look at many other factors such as rate of growth, rates of infection, survival rate and the length of time the infant needs to be in the hospital. The investigators will also look at its effect on conditions/complications of prematurity such as bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of the infant's intestines), retinopathy of prematurity (eye disease associated with prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus (a blood vessel connecting two main blood vessels coming out of the heart that does not close spontaneously (by itself).
Detailed description
The purpose of this research study is to investigate the effect of the administration of the nutritional supplements, Culturelle for Kids/Kids Culturelle in combination with Align, containing the Probiotics Lactobacillus GG and Bifidobacterium Infantis, on feeding tolerance (as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings) in high risk extremely low birth weight infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Supplemented Group | Experimental | Dietary Supplement: Probiotic Supplemented Group500,000,0000 cells of Lactobacillus GG (utilizing either Culturelle for Kids or Kids Culturelle preparation) and 500,000,000 cells of Bifidobacterium Infantis (utilizing Align capsule) diluted in 3 ml breastmilk/formula and administered enterally from first day of enteral feeds until term gestation/discharge/transfer/death (whichever occurs first) every day infant is receives enteral feedings |
| Control Group | Sham comparator | Dietary Supplement: Control Group3 ml enteral feeding of breastmilk/formula administered once daily in addition to regularly prescribed enteral feedings from day of first feeding until term gestation/discharge/transfer/death (which ever occurs first) and administered every day that infant receives enteral feedings |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Birthweight between 500-999 grams
- Apgar score greater than or equal to 3 at 5 minutes
- Infant free from any known major congenital anomalies or chromosomal/genetic anomalies
- Infant without any known cyanotic or complex congenital heart disease
- Infant NPO or on trophic enteral feedings than have been started less than 24 hours previously
Key exclusion criteria (8 listed)
- Infant born to HIV positive mother
- Infant with history of prior probiotic exposure
- Infant greater than 14 days of age
- Infant on enteral feedings for greater than 24 hours
- Infant with major congenital anomaly/chromosomal or genetic anomaly
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 |
|---|---|---|
| Probiotic Supplemented GroupAlso: Culture for Kids, Kids Culturelle, Align, Lactobacillus GG | Dietary supplement | Probiotic Supplemented Group |
| Control GroupAlso: Breastmilk, Formula | Dietary supplement | Control Group |
Primary outcome
Feeding Tolerance
Time frame: Evaluated on a daily basis until hospital discharge/transfer/death up until one year of age
Feeding Tolerance as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings
9 secondary outcomes
Necrotizing Enterocolitis (Bell's Stage 2 or greater)
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until 1 year of age
Culture proven sepsis without Necrotizing Enterocolitis
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Chronic Lung Disease
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Periventricular Leukomalacia
Time frame: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Mortality
Time frame: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Intraventricular Hemorrhage
Time frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Daily weight gain in grams
Time frame: Measured daily until time of hospital discharge/transfer/death up until one year of age
Discharge weight measured and expressed by percentile of growth for age
Time frame: Assessed at the time of discharge/transfer/death up until one year of age
Length of Stay
Time frame: Measured at time of discharge/transfer/death up until one year of age
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Background: PubMed 19707025Alfaleh K, Anabrees J, Bassler D. Probiotics reduce the risk of necrotizing enterocolitis in preterm infants: a meta-analysis. Neonatology. 2010;97(2):93-9. doi: 10.1159/000235684. Epub 2009 Aug 25.
- BackgroundAmerifit Inc. Culturelle Probiotics for Kids. Packaging information 2010
- Background: PubMed 19880141Baldassarre ME, Laforgia N, Fanelli M, Laneve A, Grosso R, Lifschitz C. Lactobacillus GG improves recovery in infants with blood in the stools and presumptive allergic colitis compared with extensively hydrolyzed formula alone. J Pediatr. 2010 Mar;156(3):397-401. doi: 10.1016/j.jpeds.2009.09.012. Epub 2009 Nov 2.
- Background: PubMed 16126048Bin-Nun A, Bromiker R, Wilschanski M, Kaplan M, Rudensky B, Caplan M, Hammerman C. Oral probiotics prevent necrotizing enterocolitis in very low birth weight neonates. J Pediatr. 2005 Aug;147(2):192-6. doi: 10.1016/j.jpeds.2005.03.054.
- Background: PubMed 19914635Chou IC, Kuo HT, Chang JS, Wu SF, Chiu HY, Su BH, Lin HC. Lack of effects of oral probiotics on growth and neurodevelopmental outcomes in preterm very low birth weight infants. J Pediatr. 2010 Mar;156(3):393-6. doi: 10.1016/j.jpeds.2009.09.051. Epub 2009 Nov 14.
- Background: PubMed 12169832Dani C, Biadaioli R, Bertini G, Martelli E, Rubaltelli FF. Probiotics feeding in prevention of urinary tract infection, bacterial sepsis and necrotizing enterocolitis in preterm infants. A prospective double-blind study. Biol Neonate. 2002 Aug;82(2):103-8. doi: 10.1159/000063096.
- Background: PubMed 20403939Deshpande G, Rao S, Patole S, Bulsara M. Updated meta-analysis of probiotics for preventing necrotizing enterocolitis in preterm neonates. Pediatrics. 2010 May;125(5):921-30. doi: 10.1542/peds.2009-1301. Epub 2010 Apr 19.
- Background: PubMed 20118747Guenther K, Straube E, Pfister W, Guenther A, Huebler A. Sever sepsis after probiotic treatment with Escherichia coli NISSLE 1917. Pediatr Infect Dis J. 2010 Feb;29(2):188-9. doi: 10.1097/INF.0b013e3181c36eb9. No abstract available.
- Background: PubMed 20224148Indrio F, Riezzo G, Raimondi F, Bisceglia M, Cavallo L, Francavilla R. Effects of probiotic and prebiotic on gastrointestinal motility in newborns. J Physiol Pharmacol. 2009 Dec;60 Suppl 6:27-31.
- Background: PubMed 20403940Hojsak I, Abdovic S, Szajewska H, Milosevic M, Krznaric Z, Kolacek S. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics. 2010 May;125(5):e1171-7. doi: 10.1542/peds.2009-2568. Epub 2010 Apr 19.
- Background: PubMed 19644396Kuitunen M, Kukkonen K, Savilahti E. Pro- and prebiotic supplementation induces a transient reduction in hemoglobin concentration in infants. J Pediatr Gastroenterol Nutr. 2009 Nov;49(5):626-30. doi: 10.1097/MPG.0b013e31819de849.
- Background: PubMed 21240300Ladd N, Ngo T. The use of probiotics in the prevention of necrotizing enterocolitis in preterm infants. Proc (Bayl Univ Med Cent). 2009 Jul;22(3):287-91. doi: 10.1080/08998280.2009.11928535. No abstract available.
- Individual participant dataSharing planned: No
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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.
Kim M Schmidt, MS, APN, NNP principal investigator
Mercy Health System
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 Supplemented Group in people with Feeding Tolerance, run by Mercy Health System at 1 site in United States.
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 11 inclusion and 8 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: stopped early, as of the sponsor's last update on 11 Oct 2018. 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 United States. 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 was stopped early. Results are not available in the source record.
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?
Feeding Tolerance (time frame: Evaluated on a daily basis until hospital discharge/transfer/death up until one year of age). 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 NCT01788761, which also lists 25 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 11 Oct 2018.