RecruitingNCT04948671

Primary Hyperparathyroidism and Gut Microbiota

Primary Hyperparathyroidism and Gut Microbiota Unravelling an Unexpected Relationship: the HYPOGEUM Study


Sponsor

Centre Hospitalier Universitaire Vaudois

Enrollment

90 participants

Start Date

Nov 17, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 30 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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

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Interventions

OTHERthere will be no intervention, this is an observational study

this is an observational study


Locations(1)

Patrizia D'amelio

Lausanne, Switzerland, Switzerland

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NCT04948671


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