UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056062 |
|---|---|
| Receipt number | R000064052 |
| Scientific Title | Efficacy of Body Granola in the treatment of diarrhea after ileocolonic reconstruction for esophageal cancer |
| Date of disclosure of the study information | 2025/01/01 |
| Last modified on | 2025/11/10 10:11:19 |
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Basic information
Public title
Efficacy of Body Granola in the treatment of diarrhea after ileocolonic reconstruction for esophageal cancer
Acronym
Efficacy of Body Granola in the treatment of diarrhea after ileocolonic reconstruction for esophageal cancer
Scientific Title
Efficacy of Body Granola in the treatment of diarrhea after ileocolonic reconstruction for esophageal cancer
Scientific Title:Acronym
Efficacy of Body Granola in the treatment of diarrhea after ileocolonic reconstruction for esophageal cancer
Region
| Japan |
Condition
Condition
esophageal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The stomach is generally used as the reconstructive organ after esophagectomy for esophageal cancer. In our hospital, we have also performed ileocolonic reconstruction to improve postoperative quality of life. Statistical analysis of our database has shown that, compared to gastric tube reconstruction, the incidence of anastomotic stenosis, suture failure, and reflux esophagitis is significantly lower in ileocolonic reconstruction. Howevere, postoperative diarrhea and use of antidiarrheal drugs are significantly higher in this reconstruction.
The objective of this study is to determine the efficacy of Body Granola, a cereal product, in patients who underwent ileocolonic reconstruction for esophageal cancer and suffered from chronic postoperative diarrhea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool characteristics before and after clinical trial intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
One month prior to the intervention, a stool sample will be taken to identify the intestinal flora. Based on the results, a personalized Body Granola tailored to each case will be created. The patients will consume 50 grams of Body Granola per day as breakfast for two months. After the trial, a follow-up stool test will be performed to assess changes in the gut microbiota and stool characteristics.
Interventions/Control_2
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent ileocolonic reconstruction at our hospital and were diagnosed with chronic diarrhea at their one-year postoperative outpatient visit.
Key exclusion criteria
The following cases are excluded
Patients with active inflammatory conditions
Patients currently taking steroids
Patients with poor nutritional status (Geriatric Nutritional Risk Index [GNRI] < 90)
Patients with food allergies
Patients who do not have a regular breakfast habit or cannot replace breakfast with the test food during the study period
Patients currently participating or planning to participate in other clinical trials involving pharmaceuticals or health foods
Patients with extremely irregular eating habits
Patients who consume alcohol excessively
Patients whose lifestyle is expected to change significantly during the study period
Patients who cannot drink milk
Patients with a history of severe diseases involving the heart, liver, kidneys, or gastrointestinal system
Pregnant patients, those planning pregnancy, or those who are breastfeeding
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Ueno |
Organization
Toranomon Hospital
Division name
Department of Gastroenterological Surgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
03-5388-1111
shiba_design_room@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ogawa |
Organization
Toranomon Hospital
Division name
Department of Gastroenterological Surgery
Zip code
105-8470
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
03-3588-1111
Homepage URL
shiba_design_room@yahoo.co.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Calbee, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toranomon Hospital
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
Tel
03-3588-1111
shiba_design_room@yahoo.co.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
| 2025 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064052
