Clinical Trial: The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus (Japan)

Tokyo, July 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058356) titled 'The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus' on July 7.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine

Condition: Condition - Systemic lupus erythematosus Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: 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.

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 Size - 50

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064981

Disclaimer: Curated by HT Syndication.