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The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus

The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus - The impact of continuous intake of prebiotic-containing granola on the gut microbiota in patients with systemic lupus erythematosus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058356
Enrollment
50
Registered
2025-07-07
Start date
2025-07-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic lupus erythematosus

Interventions

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.

Sponsors

Division of Rheumatology, Department of Internal Medicine, Toho University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactRisa Wakiya

Toho University School of Medicine Division of Rheumatology, Department of Internal Medicine

risa.wakiya@med.toho-u.ac.jp03-3762-4151

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026