Unique ID issued by UMIN | UMIN000010627 |
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Receipt number | R000012425 |
Scientific Title | A randomized phase ll study of of the Fructooligosaccharides on Mineral Absorption after Gastrectomy |
Date of disclosure of the study information | 2013/04/30 |
Last modified on | 2015/10/31 18:06:01 |
A randomized phase ll study of of the Fructooligosaccharides on Mineral Absorption after Gastrectomy
The Effect of Fructooligosaccharides on Mineral Absorption after Gastrectomy
A randomized phase ll study of of the Fructooligosaccharides on Mineral Absorption after Gastrectomy
The Effect of Fructooligosaccharides on Mineral Absorption after Gastrectomy
Japan |
gastric cancer
Gastroenterology | Gastrointestinal surgery |
Malignancy
NO
To determine The Effect of Fructooligosaccharides on Mineral Absorption after Gastrectomy
Safety,Efficacy
Exploratory
Phase II
Rate of change of the serum electrolyte level such as Fe, Ca, Mg
feasibility, adverse event, admonistration of an iron medication
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
2
Prevention
Other |
Fructooligosaccharides
no therapy
20 | years-old | <= |
Not applicable |
Male and Female
1. Histologically confirmed gastric cancer
2. Patients who provided R0 opetration
3. Age 20 years old or older
4. Patients who can take food oraly within 4 weeks after surgery
5. Adequate baseline organ fanction
6. Performance status is 0-2
7. without inflammatory bowel disease
8. without sever complication
9. Patients should sign a written informed consent
1. Patient who can not take food oraly
2. with active double cancer
3. with inflammatory bowel disease
4. with a history of severe allergy
5. Serious complication as followings,
a.bleeding on digestive tract
b.Ileus
c.intestinal paralysis
d. Interstitial pneumonia
e. Pulmonary fibrosis
f. ischemic heart disease or cardiac dysrhythmia requiring treatment
g. Heart failure
h. Renal failure
i. Hepatic cirrhosis
j. glaucoma
k. Uncontrolled diabetes mellitus
6. Any patients judged by the investigator to be
unfit to participate in the study
20
1st name | |
Middle name | |
Last name | Hisahiro Matsubara |
Graduate school of medicine, Chiba university
Frontier surgery
1-8-1, Inohana, Chuo-ku, Chiba-Chi, Chiba
0432262110
naohana718@faculty.chiba-u.jp
1st name | |
Middle name | |
Last name | Naoyuki Hanari |
Graduate school of medicine, Chiba university
Frontier surgery
1-8-1, Inohana, Chuo-ku, Chiba-Chi, Chiba
043-226-2110
naohana718@faculty.chiba-u.jp
Frontier surgery, Graduate school of medicine, Chiba university
Frontier surgery, Graduate school of medicine, Chiba university
Self funding
NO
2013 | Year | 04 | Month | 30 | Day |
Unpublished
Completed
2011 | Year | 02 | Month | 05 | Day |
2011 | Year | 02 | Month | 10 | Day |
2013 | Year | 04 | Month | 30 | Day |
2015 | Year | 10 | Month | 31 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012425
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