ElderlyNCT05584254
Effects of β-glucans on Gut Permeability and Microbiota in Elderly
A study testing yeast-beta glucan in people with Elderly and Bowel Symptoms, run by Örebro University, Sweden at 1 site in Sweden.
Trial summary
The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. Read more about this study
- Who is it for?
- Ages 55 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly, Bowel Symptoms, Prebiotics
- What is being tested?
- yeast-beta glucan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2015to 14 Aug 2017
- 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 55 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent signed by study participant
- Age >55 years
- Scoring above 2 on the dimensions for diarrhoea and constipation on the Gastrointestinal symptoms rating scale (GSRS)
- Mentally and physically fit to complete questionnaires during the study period
- Age ≥ 18 years
- Informed consent signed by the study participant
- Mentally and physically fit to complete questionnaires during the study period
Who cannot join
- Known or genic gastrointestinal diseasewith strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
- Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammtory medication (including NSAIDs)
- Healthy controls
- Previous abdominal surgery
Show all 15Show fewer
- A hypertonic condition demanding medical treatment
- Diagnosed psychiatric disease
- Lactose intolerance
- Usage of medical prescribed medications, expect oral contraceptives, during the 14 days preceding study start
- Premenstrual syndrome
- Pregnant or breast feeding
- Known or genic gastrointestinal disease, with strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of β-glucan Based Dietary Fibres on Indomethacin-induced Hyperpermeability and Gut Microbiota Composition in Elderly: A Randomized Placebo-controlled Crossover Clinical Trial
The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier function against drug-induced barrier disruption vs placebo for a cohort of elderly people with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over clinical trial.
Read the detailed description
Baseline samples for measurements of intestinal permeability (multisugar test), microbiota composition (faecal samples) and well-being (questionnaires) were collected during the first week for:
Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls) Elderly with gastrointestinal (GI) symptoms
Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial where they were blindly and randomly distributed one of the following: Soluble yeast-derived beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was taken for 3 weeks with a 1 week washout until all participants had taken all supplements. Towards the end of each supplement period, samples for measurement of intestinal permeability and microbiota were collected, in addition to questionnaires being filled out.
- Conditions
- Elderly, Bowel Symptoms, Prebiotics
- Being tested
- yeast-beta glucan
- Keywords
- elderly, prebiotics, permeability, clinical trial, Microbiota, Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yeast-beta glucanDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Elderly with gastrointestinal symptoms | Experimental | The target group for the intervention and cohort of interest used for comparison of baseline characteristics between control groups. Went into a cross-over design with 2 yeast-derived beta-glucan supplements and a placebo. Receives: Dietary Supplement: yeast-beta glucan |
| Senior orienteers | No intervention | A model of healthy aged elderly used as a control group for the baseline characteristics. |
| Young healthy adults | No intervention | A cohort of young healthy adults used as a control group for the baseline characteristics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal permeability at baseline (before indomethacin)
In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Measured: Day 1
Intestinal permeability at baseline (after indomethacin)
In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Measured: Day 1
Changes in Intestinal permeability 3 weeks after study supplementation 1 (before indomethacin).
Performed after study participants have orally taken study supplementation 1 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Measured: 3 weeks
Changes in intestinal permeability 3 weeks after study supplementation 1 (after indomethacin).
Performed after study participants have orally taken study supplementation 1 for 3 weeks.
In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Measured: 3 weeks
Changes in intestinal permeability 3 weeks after study supplementation 2 (before indomethacin)
Performed after study participants have orally taken study supplementation 2 for 3 weeks.
In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Measured: 3 weeks
Changes in intestinal permeability 3 weeks after study supplementation 2 (after indomethacin)
Performed after study participants have orally taken study supplementation 2 for 3 weeks.
In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Measured: 3 weeks
Changes in intestinal permeability 3 weeks after study supplementation 3 (before indomethacin)
Performed after study participants have orally taken study supplementation 3 for 3 weeks.
In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Measured: 3 weeks
Changes in intestinal permeability 3 weeks after study supplementation 3 (after indomethacin)
Performed after study participants have orally taken study supplementation 3 for 3 weeks.
In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Measured: 3 weeks
Secondary outcomes (18)
Microbiota diversity - at baseline
Faecal samples will be used for next-generation sequencing and analysed for diversity
Measured: Day 1
Bacterial species - at baseline
Faecal samples will be used for next-generation sequencing and analysed for bacterial species
Measured: Day 1
Changes in microbiota diversity 3 weeks after study supplementation 1
Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity
Measured: 3 weeks
Changes in bacterial species 3 weeks after study supplementation 1
Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species levels
Measured: 3 weeks
Changes in microbiota diversity 3 weeks after study supplementation 2
Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity
Measured: 3 weeks
Changes in bacterial species 3 weeks after study supplementation 2
Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species levels
Measured: 3 weeks
Changes in microbiota diversity 3 weeks after study supplementation 3
Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity
Measured: 3 weeks
Changes in bacterial species 3 weeks after study supplementation 3
Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species levels
Measured: 3 weeks
Changes in microbiota diversity - Washout (1 week after ending supplementation 1, i.e. 4 weeks after baseline)
Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity from 1 weeks washout, after ending study supplementation 1 (4 weeks after baseline)
Measured: 4 weeks
Changes in bacterial species - Washout (1 week after ending study supplementation 1, i.e. 4 weeks after baseline)
Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species from 1 weeks washout, after ending study supplementation 1 (4 weeks after baseline)
Measured: 4 weeks
Changes in microbiota diversity - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)
Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity from 1 weeks washout, after ending study supplementation 2 (4 weeks after baseline)
Measured: 4 weeks
Changes in bacterial species - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)
Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species from 1 weeks washout, after ending study supplementation 2 (4 weeks after baseline).
Measured: 4 weeks
Changes in microbiota diversity - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)
Faecal samples will be used for next-generation sequencing and analysed for changes in microbiota diversity from 1 weeks washout, after ending study supplementation 3 (4 weeks after baseline)
Measured: 4 weeks
Changes in bacterial species - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)
Faecal samples will be used for next-generation sequencing and analysed for changes in bacterial species from 1 weeks washout, after ending study supplementation 3 (4 weeks after baseline)
Measured: 4 weeks
Changes in gastrointestinal symptom questionnaire scores
The Gastrointestinal Symptoms Rating Scale (GSRS) evaluates gastrointestinal (GI) symptoms based on the 5 domains diarrhoea, constipation, reflux, indigestion and abdominal pain. The symptoms are assessed with 15 items, ranging in scores 1 to 7 depending on their severity. A score of 1 represents "no problems" and score 7 represents "severe problems". The severity of symptoms may be defined as no problems (1 point), mild (1-2 points), moderate (2-4 points), and severe (4-7 points). The scores for each domain was calculated as the mean score of each corresponding item while the mean total GSRS score reflects the general severity of GI symptoms.
Measured: up to 13 weeks
Changes in hospital and anxiety depression scores
The Hospital Anxiety and Depression Scale (HADS) was used to evaluate the psychological distress of study participants.This questionnaire consists of 14 items subdivided in two subscales for the assessment of anxiety or depression. The total score is used as a measure of general psychological distress. The minimum score is 0 and the maximum score is 21. A score > 8 on respective subscales indicates a significant level of anxiety or depression.
Measured: up to 13 weeks
Changes in perceived stress scale scores
The perceived stress scale (PSS) consists of 10 items, including a number of direct questions about current levels of experienced stress. The respondent answers how often a certain emotion has been present during the past month. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 \& 4 = 0) to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Each item is rated on a 5-point scale ranging from never (0) to almost always (4). The questions in this scale ask about the responders feelings and thoughts during the last month. In each case the questionnaire requires the respondent to indicate by circling how often they felt or thought a certain way.
Measured: Up to 13 weeks
Changes in quality of life questionnaire scores
The EuroQol 5D-5L (EQ-5D-5L) tool consists of two parts; 5Q-5D, which includes 5 items related to wellbeing and function (mobility, self-care, usual activities, pain/discomfort and anxiety/ depression) and the visual analogue scale, 5Q-5D-VAS, ranging from 0 to 100.
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Apr 2015
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- Crossover
- Model description
- 3 study products (2 different forms of yeast-beta glucan and a placebo) taken in a cross-over design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Kerry Group
- Responsible party
- Principal investigator, Robert Brummer, Örebro University, Sweden
- Investigators
- Robert J Brummer, PhD/MD, Principal investigator, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05584254
- Sponsor's protocol ID
- FODI
- Status last verified
- Mar 2023
- First submitted
- 3 Oct 2022
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of β-glucan Based Dietary Fibres on Indomethacin-induced Hyperpermeability and Gut Microbiota Composition in Elderly: A Randomized Placebo-controlled Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05584254
- Acronym / sponsor ID
- FODI
- Conditions
- Elderly, Bowel Symptoms, Prebiotics
- Keywords
- elderly, prebiotics, permeability, clinical trial, Microbiota, Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- Kerry Group
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 18 Oct 2022 (actual)
- 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.
The investigators aim was to compare healthy young adults, senior orienteers (model of healthy ageing) and elderly with gastrointestinal symptoms on intestinal permeability, microbiota compositions and well-being. In addition, assess whether 3 weeks of oral intake of soluble or dispersible forms yeast-dervied beta-glucan could improve intestinal barrier function against drug-induced barrier disruption vs placebo for a cohort of elderly people with gastrointestinal symptoms, in a randomized double blinded placebo-controlled cross-over clinical trial.
Detailed description
Baseline samples for measurements of intestinal permeability (multisugar test), microbiota composition (faecal samples) and well-being (questionnaires) were collected during the first week for:
Young healthy adults (healthy young controls) Senior orienteers (healthy elderly controls) Elderly with gastrointestinal (GI) symptoms
Thereafter only the elderly with GI symptoms continued into the randomized cross-over trial where they were blindly and randomly distributed one of the following: Soluble yeast-derived beta-glucan, dispersible (whole) yeast-derived beta-glucan and placebo. Each supplement was taken for 3 weeks with a 1 week washout until all participants had taken all supplements. Towards the end of each supplement period, samples for measurement of intestinal permeability and microbiota were collected, in addition to questionnaires being filled out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 3 study products (2 different forms of yeast-beta glucan and a placebo) taken in a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Elderly with gastrointestinal symptoms | Experimental | Dietary Supplement: yeast-beta glucanThe target group for the intervention and cohort of interest used for comparison of baseline characteristics between control groups. Went into a cross-over design with 2 yeast-derived beta-glucan supplements and a placebo. |
| Senior orienteers | No intervention | –A model of healthy aged elderly used as a control group for the baseline characteristics. |
| Young healthy adults | No intervention | –A cohort of young healthy adults used as a control group for the baseline characteristics. |
Who may qualify
- Ages
- 55 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent signed by study participant
- Age >55 years
- Scoring above 2 on the dimensions for diarrhoea and constipation on the Gastrointestinal symptoms rating scale (GSRS)
- Mentally and physically fit to complete questionnaires during the study period
- Age ≥ 18 years
Key exclusion criteria (15 listed)
- Known or genic gastrointestinal diseasewith strictures, malignance's and ischemia.
- Inflammatory bowel diseases (IBD)
- Participation in other clinical trials in the past three months.
- Intake of medications know to change the inflammatory status (i.e proton pump inhibitors, antibiotic, anti-inflammtory medication (including NSAIDs)
- Healthy controls
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 |
|---|---|---|
| yeast-beta glucan | Dietary supplement | Elderly with gastrointestinal symptoms |
Primary outcome
Intestinal permeability at baseline (before indomethacin)
Time frame: Day 1
In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Intestinal permeability at baseline (after indomethacin)
Time frame: Day 1
In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in Intestinal permeability 3 weeks after study supplementation 1 (before indomethacin).
Time frame: 3 weeks
Performed after study participants have orally taken study supplementation 1 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 1 (after indomethacin).
Time frame: 3 weeks
Performed after study participants have orally taken study supplementation 1 for 3 weeks. In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 2 (before indomethacin)
Time frame: 3 weeks
Performed after study participants have orally taken study supplementation 2 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 2 (after indomethacin)
Time frame: 3 weeks
Performed after study participants have orally taken study supplementation 2 for 3 weeks. In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 3 (before indomethacin)
Time frame: 3 weeks
Performed after study participants have orally taken study supplementation 3 for 3 weeks. In vivo gastrointestinal permeability measured by oral intake of multi-sugar test before intake of indomethacin. Urine collected over 24 hours for measurement of excreted sugars.
Changes in intestinal permeability 3 weeks after study supplementation 3 (after indomethacin)
Time frame: 3 weeks
Performed after study participants have orally taken study supplementation 3 for 3 weeks. In vivo gastrointestinal (GI) permeability measured by oral intake of multi-sugar test after intake of indomethacin (GI barrier disruption challenge). Urine collected over 24 hours for measurement of excreted sugars.
18 secondary outcomes
Microbiota diversity - at baseline
Time frame: Day 1
Bacterial species - at baseline
Time frame: Day 1
Changes in microbiota diversity 3 weeks after study supplementation 1
Time frame: 3 weeks
Changes in bacterial species 3 weeks after study supplementation 1
Time frame: 3 weeks
Changes in microbiota diversity 3 weeks after study supplementation 2
Time frame: 3 weeks
Changes in bacterial species 3 weeks after study supplementation 2
Time frame: 3 weeks
Changes in microbiota diversity 3 weeks after study supplementation 3
Time frame: 3 weeks
Changes in bacterial species 3 weeks after study supplementation 3
Time frame: 3 weeks
Changes in microbiota diversity - Washout (1 week after ending supplementation 1, i.e. 4 weeks after baseline)
Time frame: 4 weeks
Changes in bacterial species - Washout (1 week after ending study supplementation 1, i.e. 4 weeks after baseline)
Time frame: 4 weeks
Changes in microbiota diversity - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)
Time frame: 4 weeks
Changes in bacterial species - Washout (1 week after ending study supplementation 2, i.e. 4 weeks after baseline)
Time frame: 4 weeks
Changes in microbiota diversity - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)
Time frame: 4 weeks
Changes in bacterial species - Washout (1 week after ending study supplementation 3, i.e. 4 weeks after baseline)
Time frame: 4 weeks
Changes in gastrointestinal symptom questionnaire scores
Time frame: up to 13 weeks
Changes in hospital and anxiety depression scores
Time frame: up to 13 weeks
Changes in perceived stress scale scores
Time frame: Up to 13 weeks
Changes in quality of life questionnaire scores
Time frame: Up to 13 weeks
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 23 Mar 2023.
- 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.
Robert J Brummer, PhD/MD principal investigator
Örebro University, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing yeast-beta glucan in people with Elderly and Bowel Symptoms, run by Örebro University, Sweden at 1 site in Sweden.
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 7 inclusion and 15 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 23 Mar 2023. 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 Sweden. 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. 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 at baseline (before indomethacin) (time frame: Day 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2023.