Exploring Interactions Between Growth Hormone and the Microbiome
1 other identifier
observational
200
1 country
1
Brief Summary
The goal of this study is to characterize the microbiome and metabolomics of children with Growth Hormone (GH) deficiency, prior GH treatment initiation and compare it to healthy children
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2021
CompletedJuly 22, 2020
July 1, 2020
4 years
October 25, 2017
July 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in the microbiome population following Growth hormone treatment
1 year
Study Arms (2)
Study group
Children who receive Growth hormone treatment. Non Interventional
Control group
Healthy children . Non Interventional
Interventions
Eligibility Criteria
Children with GH deficiency
You may qualify if:
- Children with GH deficiency
You may not qualify if:
- Turner syndrome
- End state renal disease (ESRD)
- Prader-Willi syndrome
- Systemic illness
- Antibiotics/Antifungal in the last 3m
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rambam Health Care Campuslead
- Weizmann Institute of Sciencecollaborator
Study Sites (1)
Pediatric endocrinology unit rambam medical center
Haifa, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2017
First Posted
October 31, 2017
Study Start
November 1, 2017
Primary Completion
November 1, 2021
Study Completion
November 1, 2021
Last Updated
July 22, 2020
Record last verified: 2020-07