Investigating gut microbiota in patients with primary hyperparathyroidism
Primary Hyperparathyroidism and Gut Microbiota Unravelling an Unexpected Relationship: the HYPOGEUM Study
This study is trying to see how the bacteria in the gut of people with primary hyperparathyroidism might affect their bone health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne) |
| Trial ID | NCT04948671 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the composition of gut microbiota in patients diagnosed with primary hyperparathyroidism (PHPT) and its potential impact on bone health. Participants aged 30-80 will be categorized based on their bone mineral density and bone turnover markers, with stool and blood samples collected for analysis. The study will utilize metagenomic shotgun sequencing to assess the microbiome diversity and its relationship with immune system modulation and T cell activation. The findings could lead to novel strategies for preventing bone loss in PHPT patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30-80 years with a clinically established diagnosis of primary hyperparathyroidism.
Not a fit: Patients with secondary hyperparathyroidism or those with significant comorbidities affecting bone health or immune function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new screening tool to identify PHPT patients at risk of bone loss and suggest antimicrobial treatments to prevent skeletal complications.
How similar studies have performed: While the relationship between gut microbiota and bone health is an emerging field, this specific approach in PHPT has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of primary hyperparathyroidism clinically established * willing and able to give written informed consent * age range 30-80 years * commitment not to use any products that may influence the study outcome * ability to understand and comply with the requirements of the study. Exclusion Criteria: * impossibility to carry out DXA * type 1 and 2 diabetes mellitus * malabsorption * alcohol abuse * renal or hepatic insufficiency * history of any malignancies * use of probiotic supplement within four weeks prior to baseline * use within the past 8 weeks of medication with known influences on the immune or skeletal system * use of antibiotics during the previous two months or frequent user of antibiotics * secondary hyperparathyroidism * use of glucocorticoids or cinacalcet * history of immunological or bone-related disorders
Where this trial is running
Lausanne
- Patrizia D'amelio — Lausanne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Patrizia D'amelio, MD, PhD — Service de gériatrie et réadaptation gériatrique-CHUV
- Study coordinator: Patrizia D'amelio
- Email: Patrizia.DAmelio@chuv.ch
- Phone: +41213143712
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.