UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058356 |
|---|---|
| Receipt number | R000064981 |
| Scientific Title | The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/03 12:30:18 |
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Basic information
Public title
The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus
Acronym
The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus
Scientific Title
The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus
Scientific Title:Acronym
The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus
Region
| Japan |
Condition
Condition
Systemic lupus erythematosus
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of prebiotic-containing granola, which are thought to increase butyrate-producing bacteria, on the gut microbiota of SLE patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze the gut microbiota, the concentration of short-chain fatty acids in the intestines and blood, and changes in peripheral blood immune cells before and 8 weeks after the intake of prebiotic-containing granola.
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
To consume granola (BodyGranola, manufactured by Calbee, Inc.) containing three types of prebiotic ingredients, and 50g of prebiotic-containing granola every day for 8 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with systemic lupus erythematosus according to the 1997 ACR classification criteria or the 2019 EULAR/ACR classification criteria
2) Patients who have not changed the type or dosage of immunosuppressant drugs for at least 6 months prior to the start of the study, and who do not plan to change or add the type or dosage of immunosuppressant drugs during the study period.
3) Patients who are receiving a glucocorticoid dose of 15 mg/day or less (prednisolone equivalent) at the start of the study.
4) Patients aged 18 years or older
5) Patients who provide written consent to participate in this study
Key exclusion criteria
1) Patients who have had or are scheduled to have a colonoscopy or surgery on the large intestine within 6 months before the start of the study or during the study period.
2) Patients who have received antimicrobial agents within 1 month before the start of the study.
3) Patients who have had a change in the dosage of probiotics, laxatives, proton pump inhibitors (PPIs), or ST combination drugs within 3 months before the start of the study or during the study period.
4) Patients who have a plan to change their lifestyle significantly during the study period, such as working late at night.
5) Patients who plan to change the frequency or content of their yogurt, milk, cereal, or supplement intake during the study period.
6) Patients who are pregnant at the start of the study or plan to become pregnant during the study period.
7) Patients who the principal investigator (or sub-investigator) deems unsuitable for participation in the study for medical or social reasons.
8) Patients who do not consent to participate in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Risa |
| Middle name | |
| Last name | Wakiya |
Organization
Toho University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
risa.wakiya@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Wakiya |
Organization
Toho University School of Medicine
Division name
Division of Rheumatology, Department of Internal Medicine
Zip code
143-8541
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
risa.wakiya@med.toho-u.ac.jp
Sponsor or person
Institute
Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
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
Toho University School of Medicine
Address
6-11-1 Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151
risa.wakiya@med.toho-u.ac.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 | 07 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064981
