Unique ID issued by UMIN | UMIN000046664 |
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Receipt number | R000053232 |
Scientific Title | Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis |
Date of disclosure of the study information | 2022/01/17 |
Last modified on | 2022/01/17 22:34:01 |
Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis
Randomized interventional study of add-on effects of the nutritional therapy on standard treatments for patients with ulcerative colitis
Nutritional Therapy Intervention Study for Patients with Ulcerative Colitis
Japan |
Ulcerative Colitis
Gastroenterology |
Others
NO
This study investigated whether nutritional guidance to promote zinc intake and a Japanese diet (high in n-3 fatty acids) could induce clinical remission in patients with mild active ulcerative colitis (UC).
Efficacy
Confirmatory
Explanatory
Not applicable
The primary endpoint was clinical remission at 24 weeks.
Secondary endpoints were the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scores, the clinical activity index (CAI) evaluated based on symptoms, and biomarkers, including the zinc levels, at 12 and 24 weeks.
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
No treatment
NO
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Food |
nutritional guidance (intervention group)
control group
15 | years-old | <= |
99 | years-old | > |
Male and Female
Patients had mild active UC (patients with a UCEIS score of 2-4 points, CAI score of 5-6 points, and a distribution of the UCEIS and CAI scores at admission indicating that the patient was not in remission) were enrolled in the study.
Patients undergoing colonoscopy without pretreatment; those with difficulty following nutritional guidance; those with an intestinal obstruction, fistula, history of colorectal surgery, moderate to severe active-phase UC, diverticulitis, or massive colorectal bleeding; and those with anemia or other underlying conditions except UC were excluded.
20
1st name | Yoshikazu |
Middle name | |
Last name | Tsuzuki |
Saitama medical university
Department of Gastroenterology
350-0451
Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
+81-49-276-1667
ytsuzuki38@gmail.com
1st name | Kazuya |
Middle name | |
Last name | Miyaguchi |
Saitama Medical University
Department of Gastroenterology
350-0451
Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
+81-49-276-1667
kaz.hr77@gmail.com
Saitama Medical University
Saitama Medical University
Self funding
Saitama medical university IRB Committee
Morohongo38, Moroyamamachi, Iruma-gun, Saitama Japan
+81492761667
hirb@saitama-med.ac.jp
NO
2022 | Year | 01 | Month | 17 | Day |
Unpublished
20
Completed
2018 | Year | 12 | Month | 13 | Day |
2019 | Year | 02 | Month | 04 | Day |
2019 | Year | 02 | Month | 04 | Day |
2021 | Year | 12 | Month | 30 | Day |
2022 | Year | 01 | Month | 17 | Day |
2022 | Year | 01 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053232
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