NCT04948671

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

November 17, 2021

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

April 13, 2026

Status Verified

September 1, 2024

Enrollment Period

4.2 years

First QC Date

June 28, 2021

Last Update Submit

April 7, 2026

Conditions

Hyperparathyroidism, Primary

Keywords

Primary HyperparathyroidismGut microbiotaimmune system

Outcome Measures

Primary Outcomes (12)

  • Gut microbiota diversity (Bray- Curtis beta diversity index)

    Measured by Metagenomics Shotgun sequencing and analysis

    1 year

  • FOXP3,number of copy

    gene expression measured by real time PCR

    1 year

  • Il 17,number of copy

    gene expression measured by real time PCR

    1 year

  • TNF alpha ,number of copy

    gene expression measured by real time PCR

    1 year

  • IL 4 ,number of copy

    gene expression measured by real time PCR

    1 year

  • FOXp3 number of positive cells

    Measured by flow citometry

    1 year

  • TNF alpha number of positive cells

    Measured by flow citometry

    1 year

  • IL 17 number of positive cells

    Measured by flow citometry

    1 year

  • IL 4 number of positive cells

    Measured by flow citometry

    1 year

  • production of IL-17

    ELISPOT analyses of stimulated T cells

    2 year

  • production of TNF alpha

    ELISPOT analyses of stimulated T cells

    2 year

  • production of RANKL

    ELISPOT analyses of stimulated T cells

    2 year

Study Arms (2)

not bone looser

patients affected by primary hyperparathyroidism not bone looser

Other: there will be no intervention, this is an observational study

bone looser

patients affected by primary hyperparathyroidism bone looser

Other: there will be no intervention, this is an observational study

Interventions

there will be no intervention, this is an observational studyOTHER

this is an observational study

bone loosernot bone looser

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We will enroll in the project 90 patients affected by Primary hyperparathyroidism

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patrizia D'amelio

Lausanne, Switzerland, 1012, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood samples will be collected and frozen

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Patrizia D'amelio, MD, PhD

    Service de gériatrie et réadaptation gériatrique-CHUV

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associated professor

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 2, 2021

Study Start

November 17, 2021

Primary Completion

February 7, 2026

Study Completion

February 28, 2026

Last Updated

April 13, 2026

Record last verified: 2024-09

Locations

CH(1)