UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043525 |
|---|---|
| Receipt number | R000049697 |
| Scientific Title | A pilot study to identify the prevention of food allergy by administering synbiotics to pregnant women and newborns |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2021/03/04 21:30:45 |
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Basic information
Public title
A pilot study to identify the prevention of food allergy by administering synbiotics to pregnant women and newborns
Acronym
A study to identify the prevention of food allergy by the administration of synbiotics
Scientific Title
A pilot study to identify the prevention of food allergy by administering synbiotics to pregnant women and newborns
Scientific Title:Acronym
A study to identify the prevention of food allergy by the administration of synbiotics
Region
| Japan |
Condition
Condition
food allergy
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy of synbiotics on preventing the development of food allergy in a population at high risk of developing a food allergy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences and changes in the type and diversity of intestinal microflora in children at 4 months of age
Key secondary outcomes
(1)Presence of immediate food allergy at 1 year of age
(2)Changes in short-chain fatty acids in the blood
(3)Differences and changes in the types and diversity of breast milk and skin flora
(4)Sensitization to food allergen at 1 year of age
(5)Presence and severity of eczema at 1 year of age
(6)Stratify results affected by mode of delivery, method of child nutrition, and child skin condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In intervention group A, pregnant women consume synbiotics (Lactobacillus rhamnosus GG, Bifidobacterium bifidum, and 1-kestose) daily from 34-35 weeks gestation until postpartum day 5, and newborns from day 0 to day 5.
Interventions/Control_2
In intervention group B, newborns will take synbiotics (Lactobacillus rhamnosus GG, Bifidobacterium bifidum, 1-kestose) from day 0 to day 5.
Interventions/Control_3
In a non-intervention group, participants will not take synbiotics
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Pregnant women at 34 to 35 weeks gestation
2. Either the pregnant woman or her partner has one or more of the following allergic diseases: atopic dermatitis, bronchial asthma, food allergy, allergic rhinitis, allergic conjunctivitis
3. A child born on day 0 to a pregnant woman who meets the above criteria 1 and 2.
Key exclusion criteria
1.The pregnant woman who has an obvious underlying medical condition
2.Twins
3.Premature birth or low birth weight infant
4.Severe neonatal asphyxia (Apgar score <4)
5.Children deemed by their doctor to be unsuitable for participation in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
yana@foodallergy.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Miura |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of pediatrics
Zip code
252-0392
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan
TEL
042-742-8311
Homepage URL
yoko6299@gmail.com
Sponsor or person
Institute
National Hospital Organization Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Technical Research Laboratory Takanashi MilkProducts Co. Ltd. Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Sagamihara National Hospital
Address
18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
Tel
042-742-8311
222-rinri@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 03 | Month | 04 | Day |
Last modified on
| 2021 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049697
