Gastrointestinal System DiseaseShirotaNCT04346576
Probiotics Prevent Health Problems in Children
A study testing Probiotics prevent health problems in children in people with Gastrointestinal System Disease and Respiratory System, run by National Institute of Nutrition, Vietnam at 1 site in Vietnam.
Trial summary
Randomized controlled field trial of a probiotics to assess its roles in the prevention or improvement of constipation and diarrhea, acute respiratory infection, nutrition improving in Vietnam children. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal System Disease, Respiratory System
- What is being tested?
- Probiotics prevent health problems in children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteVietnam
- Study dates
- 5 Oct 2017to 5 Jun 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children of either sex aged 3-5 years who are attending the school
- The parents/ guardians of each participating child agreed in their child participant and signed the consent form.
Who cannot join
- Children with Alzheimer's disease
- Children using long-term antibiotics
- Children with inborn chronic disease such as congenital heart disease; congenital chronic kidney failure.
- Two children in the same home (the same parents)
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Cong Chinh, Van Thang, Dinh Thanh and Yen Thai
Thanh Hóa, Thanh Hóa Province, 84
About this study
Official title: The Effects of Fermented Milk Including Lactobacillus Casei Strain Shirota Regarding Gastrointestinal Symptoms, Respiratory Infection, Nutrition Improving in Vietnam Children 3-5 Years of Age
Randomized controlled field trial of a probiotics to assess its roles in the prevention or improvement of constipation and diarrhea, acute respiratory infection, nutrition improving in Vietnam children.
In the present proposal, the investigators plan to examine if daily intake of a probiotic beverage, which includes 6.5 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea and constipation in Vietnam with 3 objectives:
- To assess the impact of probiotics in the prevention or improvement of diarrhea and constipation in children
- To assess the impact of probiotics in the prevention of disease of respiratory system (ARI)
- To assess the impact of probiotics on nutrition and growth of the children
Read the detailed description
It will be a randomized controlled field trial involving 1036 children aged between 3 and 5 years in some communities in Vietnam. The 1036 children will be identified through demographic survey. Based on available National data to determine the province - Thanh Hoa province (http://viendinhduong.vn/news/vi/106/61/0/a/so-lieu-thong-ke-ve-tinh-trang-dinh-duong-tre-em-qua-cac-nam.aspx), after surveying 2.000 children at least 6 communes, it is expected to give 1036 eligible children. The study will be randomized where the treatment group will receive Probiotic drink, which includes 65 billion probiotic Lactobacillus casei strain Shirota, one bottle (65ml) daily for 12 weeks and the non-treatment arm will not receive the probiotic drink for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will include 518 children each. All the children under the study will be visited daily by a by teachers at kindergartens (when the children attend class), or by parents (when the children are at home). The surveillance persons will supervise the intake of Probiotic drink by the children, the status of diarrhea and constipation, disease of respiratory in children and recording the data every day. All the children will be followed up daily for 4 weeks (after stop the intervention) for identification of diarrhea and constipation cases. Functional constipation defined by ROME III was evaluated every 4 weeks. It was diagnosed by doctors with reference to the logbook records. The stool consistency was recorded in a daily logbook based on the Bristol Stool Form Scale. Diarrhea will be defined as three or more abnormally loose or liquid stools within last 24 h period. Details of such diarrhea cases including their duration, frequency of stool, type of stool (watery or bloody), other associated symptoms like abdominal pain etc. will be recorded. Qualified medical doctors will provide services for appropriate counseling and treatment and severe cases will be referred to the hospital. Doctors at commune stations are collaborate to provide service for appropriate counseling and treatment during the time of trial. And doctors at district hospitals and Thanh Hoa province will be collaborated to treat with severe cases when they are referred to. Measurements of height, weight and mid-arm circumference will assess nutritional status of the children at the beginning of the study, at the end of 4, 8, 12 weeks and (at the end of 16 weeks) follow up for 4 weeks. The outcome variables will be the incidence of diarrhea, constipation, disease of respiratory, nutrition status and the efficacy of the probiotics will be calculated by comparing the diarrhea, constipation incidence, disease of respiratory between the two groups at 5 different point of time (at baseline, the end of 4, 8, 12 weeks and 16 weeks). Nutritional improving will be compared similarly at baseline, the end of 4, 8, 12 weeks and 16 weeks.
- Being tested
- Probiotics prevent health problems in children
- Keywords
- Lactobacillus casei strain Shirota, diarrhea, constipation, respiratory system, nutrition status, children 3-5 years old
- Medical subject headings
- Digestive System Diseases, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics prevent health problems in childrenDietary supplement
Also called Yakult fermented milk
A controlled field trial was conducted with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed fermented milk 65 mL/day containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group (n=493) were not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention and after the 4-week follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics (LcS per 65 mL) prevent health problems in children | Experimental | Probiotic test product was fermented milk containing 6.5 billion of LcS per 65 mL (108 CFU/mL), manufactured by Yakult Vietnam, Co., Ltd. The nutritional composition of the test product is 0.8 g of protein, <0.1 g of fat, 12.4 g of carbohydrates, and the total energy is 52.7 kcal per bottle. Subjects were asked to drink one bottle of the test product per day after lunch for 12 weeks on consecutive days. The test products were stored in a refrigerator (< 10°C), protected from direct sunlight, and used before their expiration date. Adherence to the intervention protocol was confirmed as follows; teachers at kindergartens or parents at home provided the probiotic drinks (1 bottle/day x 7 days/week) after lunch. Receives: Dietary Supplement: Probiotics prevent health problems in children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of constipation disease
In the primary analysis, the denominator in the calculation of incidence of constipation disease (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Incidence of respiratory (ARI)
In the primary analysis, the denominator in the calculation of incidence (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Average duration of diarrhea
Average duration of diarrhea were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. If there are at least 3 diarrhea-free days between a first and a second episode of diarrhea in the same individual, the second diarrhea episode were considered as a separate (new) diarrheal episode. Evaluation of probiotic efficacy thus pertains to number of diarrheal episodes. Average duration of diarrhea were average of the day number of episodes that were determined.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Incidence of diarrhea disease
n the primary analysis, the denominator in the calculation of incidence of diarrhea disease (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Average duration of constipation
Average duration of constipation were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. The diagnosed constipation days between a first and a second episode of constipation in the same individual, the second constipation episode were considered as a separate (new) constipation episode. Evaluation of probiotic efficacy thus pertains to number of constipation episodes. Average duration of constipation were average of the day number of episodes that were determined.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Average duration of ARI
Average duration of ARI were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. The diagnosed ARI days between a first and a second episode of ARI in the same individual, the second ARI episode were considered as a separate (new) ARI episode. Evaluation of probiotic efficacy thus pertains to number of ARI episodes. Average duration of ARI were average of the day number of episodes that were determined.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
The weight gain
Using TANITA electronic scales with accuracy up to 0.1 kg determine the weight of children.
The weight gain were determined the weight change of children after intervention compared of that before intervention. These weight gain were compared among the treatment and non-treatment group.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
The height gain
The height was measured by the vertical height meter with accuracy up to 1 mm. The height gain were determined the height change of children after intervention compared of that before intervention. These height gain were compared among the treatment and non-treatment group.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
The changes in the Z-score
Assess the nutritional status of children based on Z-Score (WHO-2006). The change in Zscore were compared among the treatment and non-treatment group.
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Secondary outcomes (1)
Dietary intake
Using 24 hours recall to do the dietary intake
Measured: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start5 Oct 2017
- Primary completion5 Jan 2018
- Study completion5 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal System 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A controlled field trial was implemented with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed 65 mL/day of fermented milk containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group did not. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline and 4, 8, and 12-week of intervention and after the 4-week follow up period.
- Masking
- None (open label)
- Enrolment
- 1,036 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Nutrition, Vietnam
- Sponsor type
- Other government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, TRUONG TUYET MAI, National Institute of Nutrition, Vietnam
- Investigators
- Tuyen Le, Study director, National Institute of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346576
- Sponsor's protocol ID
- NINVN12017
- Other IDs
- R01DA013131
- Acronym
- Shirota
- Status last verified
- Apr 2020
- First submitted
- 29 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Fermented Milk Including Lactobacillus Casei Strain Shirota Regarding Gastrointestinal Symptoms, Respiratory Infection, Nutrition Improving in Vietnam Children 3-5 Years of Age
- ClinicalTrials.gov ID
- NCT04346576
- Acronym / sponsor ID
- Shirota / NINVN12017
- Keywords
- Lactobacillus casei strain Shirota, diarrhea, constipation, respiratory system, nutrition status, children 3-5 years old
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,036 participants (actual)
- Lead sponsor
- National Institute of Nutrition, VietnamOther government
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Oct 2017 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 15 Apr 2020 (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.
Randomized controlled field trial of a probiotics to assess its roles in the prevention or improvement of constipation and diarrhea, acute respiratory infection, nutrition improving in Vietnam children.
In the present proposal, the investigators plan to examine if daily intake of a probiotic beverage, which includes 6.5 billion probiotic Lactobacilli, has a beneficial role in protecting children from infectious diarrhea and constipation in Vietnam with 3 objectives:
- To assess the impact of probiotics in the prevention or improvement of diarrhea and constipation in children
- To assess the impact of probiotics in the prevention of disease of respiratory system (ARI)
- To assess the impact of probiotics on nutrition and growth of the children
Detailed description
It will be a randomized controlled field trial involving 1036 children aged between 3 and 5 years in some communities in Vietnam. The 1036 children will be identified through demographic survey. Based on available National data to determine the province - Thanh Hoa province (http://viendinhduong.vn/news/vi/106/61/0/a/so-lieu-thong-ke-ve-tinh-trang-dinh-duong-tre-em-qua-cac-nam.aspx), after surveying 2.000 children at least 6 communes, it is expected to give 1036 eligible children. The study will be randomized where the treatment group will receive Probiotic drink, which includes 65 billion probiotic Lactobacillus casei strain Shirota, one bottle (65ml) daily for 12 weeks and the non-treatment arm will not receive the probiotic drink for 12 weeks. Randomization will be done in a ratio of 1:1, i.e., the study arm and control arm will include 518 children each. All the children under the study will be visited daily by a by teachers at kindergartens (when the children attend class), or by parents (when the children are at home). The surveillance persons will supervise the intake of Probiotic drink by the children, the status of diarrhea and constipation, disease of respiratory in children and recording the data every day. All the children will be followed up daily for 4 weeks (after stop the intervention) for identification of diarrhea and constipation cases. Functional constipation defined by ROME III was evaluated every 4 weeks. It was diagnosed by doctors with reference to the logbook records. The stool consistency was recorded in a daily logbook based on the Bristol Stool Form Scale. Diarrhea will be defined as three or more abnormally loose or liquid stools within last 24 h period. Details of such diarrhea cases including their duration, frequency of stool, type of stool (watery or bloody), other associated symptoms like abdominal pain etc. will be recorded. Qualified medical doctors will provide services for appropriate counseling and treatment and severe cases will be referred to the hospital. Doctors at commune stations are collaborate to provide service for appropriate counseling and treatment during the time of trial. And doctors at district hospitals and Thanh Hoa province will be collaborated to treat with severe cases when they are referred to. Measurements of height, weight and mid-arm circumference will assess nutritional status of the children at the beginning of the study, at the end of 4, 8, 12 weeks and (at the end of 16 weeks) follow up for 4 weeks. The outcome variables will be the incidence of diarrhea, constipation, disease of respiratory, nutrition status and the efficacy of the probiotics will be calculated by comparing the diarrhea, constipation incidence, disease of respiratory between the two groups at 5 different point of time (at baseline, the end of 4, 8, 12 weeks and 16 weeks). Nutritional improving will be compared similarly at baseline, the end of 4, 8, 12 weeks and 16 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A controlled field trial was implemented with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed 65 mL/day of fermented milk containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group did not. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline and 4, 8, and 12-week of intervention and after the 4-week follow up period.
| Arm | Type | Receives |
|---|---|---|
| Probiotics (LcS per 65 mL) prevent health problems in children | Experimental | Dietary Supplement: Probiotics prevent health problems in childrenProbiotic test product was fermented milk containing 6.5 billion of LcS per 65 mL (108 CFU/mL), manufactured by Yakult Vietnam, Co., Ltd. The nutritional composition of the test product is 0.8 g of protein, <0.1 g of fat, 12.4 g of carbohydrates, and the total energy is 52.7 kcal per bottle. Subjects were asked to drink one bottle of the test product per day after lunch for 12 weeks on consecutive days. The test products were stored in a refrigerator (< 10°C), protected from direct sunlight, and used before their expiration date. Adherence to the intervention protocol was confirmed as follows; teachers at kindergartens or parents at home provided the probiotic drinks (1 bottle/day x 7 days/week) after lunch. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children of either sex aged 3-5 years who are attending the school
- The parents/ guardians of each participating child agreed in their child participant and signed the consent form.
Key exclusion criteria (4 listed)
- Children with Alzheimer's disease
- Children using long-term antibiotics
- Children with inborn chronic disease such as congenital heart disease; congenital chronic kidney failure.
- Two children in the same home (the same parents)
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 |
|---|---|---|
| Probiotics prevent health problems in childrenAlso: Yakult fermented milkA controlled field trial was conducted with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed fermented milk 65 mL/day containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group (n=493) were not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention and after the 4-week follow-up period. | Dietary supplement | Probiotics (LcS per 65 mL) prevent health problems in children |
Primary outcome
Incidence of constipation disease
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
In the primary analysis, the denominator in the calculation of incidence of constipation disease (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.
Incidence of respiratory (ARI)
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
In the primary analysis, the denominator in the calculation of incidence (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.
Average duration of diarrhea
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Average duration of diarrhea were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. If there are at least 3 diarrhea-free days between a first and a second episode of diarrhea in the same individual, the second diarrhea episode were considered as a separate (new) diarrheal episode. Evaluation of probiotic efficacy thus pertains to number of diarrheal episodes. Average duration of diarrhea were average of the day number of episodes that were determined.
Incidence of diarrhea disease
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
n the primary analysis, the denominator in the calculation of incidence of diarrhea disease (/100 children/ week) will consist of the number of eligible children living in the study area at the time of the trial who were in between 3-5 year of age. Individuals will be included in the denominator until out-migration, death. All children will be included in the corresponding group during analyses.
Average duration of constipation
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Average duration of constipation were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. The diagnosed constipation days between a first and a second episode of constipation in the same individual, the second constipation episode were considered as a separate (new) constipation episode. Evaluation of probiotic efficacy thus pertains to number of constipation episodes. Average duration of constipation were average of the day number of episodes that were determined.
Average duration of ARI
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Average duration of ARI were calculated during 12 weeks of intervention period and 4 weeks of follow-up period. The diagnosed ARI days between a first and a second episode of ARI in the same individual, the second ARI episode were considered as a separate (new) ARI episode. Evaluation of probiotic efficacy thus pertains to number of ARI episodes. Average duration of ARI were average of the day number of episodes that were determined.
The weight gain
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Using TANITA electronic scales with accuracy up to 0.1 kg determine the weight of children. The weight gain were determined the weight change of children after intervention compared of that before intervention. These weight gain were compared among the treatment and non-treatment group.
The height gain
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
The height was measured by the vertical height meter with accuracy up to 1 mm. The height gain were determined the height change of children after intervention compared of that before intervention. These height gain were compared among the treatment and non-treatment group.
The changes in the Z-score
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
Assess the nutritional status of children based on Z-Score (WHO-2006). The change in Zscore were compared among the treatment and non-treatment group.
1 secondary outcome
Dietary intake
Time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)
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 15 Apr 2020.
- 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.
Tuyen Le study director
National Institute of Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics prevent health problems in children in people with Gastrointestinal System Disease and Respiratory System, run by National Institute of Nutrition, Vietnam at 1 site in Vietnam.
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 2 inclusion and 4 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 15 Apr 2020. 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 Vietnam. 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?
Incidence of constipation disease (time frame: 16 weeks (12 weeks of intervention and 4-weeks follow-up)). The study lists 9 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 15 Apr 2020; AzTrials last refreshed its copy on 31 Oct 2026.