Unique ID issued by UMIN | UMIN000033805 |
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Receipt number | R000038540 |
Scientific Title | The efficacy of probiotics on intestinal flora for surgical baby |
Date of disclosure of the study information | 2018/08/20 |
Last modified on | 2018/08/19 23:22:08 |
The efficacy of probiotics on intestinal flora for surgical baby
The efficacy of probiotics on intestinal flora for surgical baby
The efficacy of probiotics on intestinal flora for surgical baby
The efficacy of probiotics on intestinal flora for surgical baby
Japan |
congenital anomaly
Surgery in general | Pediatrics | Operative medicine |
Child |
Others
NO
To investigate how intestinal flora in neonatal surgery cases changes by probiotic treatment and new bacterial flora is established.
Efficacy
Confirmatory
Pragmatic
Phase IV
Cytokines in blood (IL6, IL10, IL12, IL18, IFNg), IgG, IgA, IgE are measured. DNA analysis of intestinal microflora in feces with next generation sequencer.
For each item, compare with neonatal surgery case / non-surgical case.
Blood and fecal samples should be taken at the following schedule.
(Surgery case: at birth, immediately before surgery, immediately after surgery, 1st day after surgery, 3rd day, 7th day
Non-surgical case: at birth, 1st day after birth, 3rd day, 7th day)
We will examine the correlation between postoperative clinical course and the above results.
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
No treatment
2
Treatment
Food |
After starting feeding, 1 kg of LKM 512 bifidus per day and taking it until discharge date (14 - 28 days)
Of the newborn hospital admitted to our hospital (including cases transferred from other hospital births), it is divided into 2 groups of surgical cases, surgery not yet performed, and normal neonates
1 | days-old | <= |
28 | days-old | >= |
Male and Female
Of the newborn hospital admitted to our hospital (including cases transferred from other hospital births), surgical cases, non surgical cases, normal newborns are examined
1) From Committee Approval date to born on March 1, 2019
2) The presence or absence of serious complication malformation (chromosomal abnormality, complex heart disease) is not required
3) Whether actively treated, palliative or restrictive treatment was selected
1) The patient was considered prenatally diagnosed as requiring surgery but was aborted or in utero fetal death.
2) Patients who underwent surgery after 28 days of age
50
1st name | |
Middle name | |
Last name | MANABU OKAWADA |
Juntendo University School of Medicine
Pediatric General & Urogenital Surgery
Hongo 2-1-1, Bunkyo-ku tokyo
03-3813-3111
manabu-o@juntendo.ac.jp
1st name | |
Middle name | |
Last name | MANABU OKAWADA |
Juntendo University School of Medicine
Pediatric General & Urogenital Surgery
Hongo 2-1-1, Bunkyo-ku tokyo
03-3813-3111
manabu-o@juntendo.ac.jp
Juntendo University School of Medicine
Kyodo Milk Industry Co. Ltd
Profit organization
Kyodo Milk Industry Co. Ltd
NO
順天堂大学病院(東京都)
2018 | Year | 08 | Month | 20 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 11 | Month | 01 | Day |
2018 | Year | 08 | Month | 19 | Day |
2018 | Year | 08 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038540
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