Fisetin for Immune Deficiency-Related Lung Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Avni Joshi

Disqualifiers: Pregnancy, Tobacco use, Excessive caffeine, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the supplement Fisetin can help treat common variable immunodeficiency (CVID), a condition affecting the immune system that can lead to lung problems. Participants will receive either Fisetin or a placebo to assess improvements. Individuals diagnosed with CVID and potential lung issues related to it might be suitable for this study. The trial requires taking the supplement or placebo on specific days over a month. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your doctor for guidance.

Is there any evidence suggesting that Fisetin is likely to be safe for humans?

Research has shown that fisetin, a natural substance found in fruits like strawberries and apples, offers safety and health benefits. Animal and lab studies suggest it might help with diseases by reducing inflammation and stress in cells. People who have used fisetin generally tolerated it well, with few side effects reported.

Since this trial is in an early stage, most safety information comes from earlier studies rather than large groups of people. However, testing fisetin in humans suggests that earlier tests found it reasonably safe. For those considering joining a trial with fisetin, it's helpful to know that while more research is needed, initial findings are promising with manageable risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for immune deficiency-related lung disease?

Unlike traditional treatments for immune deficiency-related lung disease, which often focus on managing symptoms with medications like corticosteroids or bronchodilators, Fisetin offers a unique approach. Fisetin is a natural compound found in fruits like strawberries and is known for its antioxidant and anti-inflammatory properties. Researchers are excited about Fisetin because it may directly target the underlying inflammation and oxidative stress involved in lung disease, potentially improving lung function without the side effects associated with current therapies. Additionally, its natural origin and short treatment cycles make it a promising alternative for those seeking less intensive treatment options.

What evidence suggests that Fisetin might be an effective treatment for immune deficiency-related lung disease?

This trial will compare Fisetin with a placebo to evaluate its effects on immune deficiency-related lung disease. Research has shown that Fisetin, a natural substance found in fruits like strawberries and apples, may help manage long-term health issues. As an antioxidant, it helps protect cells from harm. Evidence also suggests that Fisetin can target old cells contributing to aging and inflammation. By reducing inflammation, Fisetin might address problems related to weak immune systems. While these findings are promising, more research is needed to confirm its effectiveness specifically for immune issues like common variable immunodeficiency (CVID). ^{2 3 6 7 8}

Who Is on the Research Team?

Avni Joshi, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with Common Variable Immunodeficiency (CVID) and associated lung disease, who have been diagnosed according to international standards. Participants must not be pregnant or at risk of pregnancy without contraception, should not use tobacco or consume excessive caffeine, and must be capable of following the study's procedures.

Inclusion Criteria

IgA levels are abnormal.

Patient must be able and willing to comply with the requirements of this study protocol

I am a woman who cannot become pregnant because I am postmenopausal or have been surgically sterilized.

Exclusion Criteria

People who are in prison, living in an institution, or who may have difficulty making their own decisions, such as those with dementia.

Pregnant and/or lactating. Women of childbearing potential (WCBP) must have a negative pregnancy test within 72 hours prior to randomization

I am currently in the hospital or might need to be hospitalized soon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Fisetin or placebo for 2 cycles of 2 consecutive days each, on days 0 & 1 and repeated on days 28 & 29

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in FVC, radiologic imaging, and quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Fisetin
• Placebo

Trial Overview The trial is testing Fisetin, a dietary supplement, against a placebo to see if it can treat interstitial lung disease in patients with CVID. The effectiveness of Fisetin will be compared to that of an inactive substance to determine its potential as a treatment option.

How Is the Trial Designed?

Group I: Fisetin Group Experimental Treatment 1 Intervention

Subjects will receive the supplement, Fisetin, for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)

Group II: Placebo Group Placebo Group 1 Intervention

Subjects will receive placebo for 2 cycles of 2 consecutive days (first on days 0 \& 1 and then repeated on days 28 \& 29)

Who Is Running the Clinical Trial?

Avni Joshi

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a mouse model of acute pulmonary inflammation, the flavonoid fisetin significantly reduced levels of inflammatory markers and mediators, outperforming other flavonoids and the glucocorticoid dexamethasone.

Fisetin's ability to lower myeloperoxidase levels and gene expression of inflammatory mediators suggests it could be a promising candidate for treating pulmonary inflammatory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of LPS-induced pulmonary inflammation by specific flavonoids. Geraets, L., Haegens, A., Brauers, K., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3689181/

Fisetin: A Dietary Antioxidant for Health Promotion - PMC One such flavonoid, fisetin (3,3′,4′,7-tetrahydroxyflavone), is found in various fruits and vegetables, such as strawberry, apple, persimmon, grape, onion, and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27671819/

Fisetin and Its Role in Chronic Diseases - PubMed - NIH Fisetin (3,3',4',7-tetrahydroxyflavone) is a dietary flavonoid found in various fruits (strawberries, apples, mangoes, persimmons, kiwis, and grapes) ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0047637424000952

Fisetin as a senotherapeutic agent: Evidence and ... Our review of available data suggests that targeting senescent cells with fisetin offers a promising strategy for managing multiple chronic diseases.

4. spandidos-publications.com spandidos-publications.com/10.3892/ijmm.2018.3582

International Journal of Molecular Medicine Fisetin (3,3',4',7-tetrahydroxyflavone) is a naturally occurring ... Inflammatory cells secrete chemical regulators related to asthma development ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S094471132200201X

Recent advances in potential of Fisetin in the management ... Fisetin is an effective flavonoid with antioxidant and anti-inflammatory properties, proven to be cardioprotective against IR injury in both in-vitro and invivo ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9589363/

The neuroprotective effects of fisetin, a natural flavonoid in ... Several preclinical studies revealed that fisetin has potential benefits against neurological health complications and neurodegenerative diseases like AD, PD.

7. dergipark.org.tr dergipark.org.tr/en/download/article-file/1649692

Molecular and Therapeutic Effects of Fisetin Flavonoid in ... Studies conducted in cell culture and animal models have shown that fisetin has potential healing effects on diseases by affecting various signal pathways. The ...

8. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2022.960601/full

Fisetin reduces the senescent tubular epithelial cell burden ... Fisetin plays a senolytic role by specifically eliminating senescent cells, inhibiting cell proliferation, and exerting anti-inflammatory, anti-oxidant, and ...