Primary Hyperparathyroidism and Gut Microbiota (NCT04948671) | Clinical Trial Compass
TerminatedNot Applicable
Primary Hyperparathyroidism and Gut Microbiota
Stopped: not enough participants
Switzerland25 participantsStarted 2021-11-17
Plain-language summary
Primary hyperparathyroidism (PHPT) may induce bone loss according with the composition of the gut microbiota (GM), and particularly, on the presence of intestinal bacterial that induce T helper 17 differentiation.
We will evaluate GM composition and evaluate how GM modulates immune system in patients affected by PHPT with or without skeletal involvement. Furthermore, we will unravel the causal relationship between GM composition and T cells activation.
Upon success, HYPOGEUM will show that GM sequencing is a screening tool to identify PHPT that will lose bone, suggesting novel strategies with antimicrobial treatments to prevent bone loss.
HYPOGEUM will yield essential data to understand and prevent skeletal complications associated with PHPT.
Who can participate
Age range
30 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Gut microbiota diversity (Bray- Curtis beta diversity index)