CClinicalTrials.gg
Status unknownNCT03327207Updated Jul 22, 2020

Exploring Interactions Between Growth Hormone and the Microbiome

An observational study in Growth Hormone Deficiency, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-07-22.

Sponsored by Rambam Health Care Campus · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
3 Years to 18 Years
Sex
All
01

Study 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

02

Conditions studied

  • Growth Hormone Deficiency
03

Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Children with GH deficiency

Inclusion criteria

  • Children with GH deficiency

Exclusion criteria

Exclusion Criteria:

  • Turner syndrome
  • End state renal disease (ESRD)
  • Prader-Willi syndrome
  • Systemic illness
  • Antibiotics/Antifungal in the last 3m
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Study group

    Children who receive Growth hormone treatment. Non Interventional

    Other: Non Interventional

  • Control group

    Healthy children . Non Interventional

    Other: Non Interventional

Interventions

  • OtherNon Interventional

    Non Interventional

05

What researchers measure

Primary outcomes

  1. Changes in the microbiome population following Growth hormone treatment

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Pediatric endocrinology unit rambam medical center
    Haifa, Israel
    • Smadar Shilo, MD · Contact · 97247774400
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03327207
Lead sponsor
Rambam Health Care Campus
Collaborators
Weizmann Institute of Science
Responsible party
Sponsor
First posted
Oct 31, 2017
Start date
Nov 1, 2017
Primary completion
Nov 2021 (estimated)
Completion
Nov 2021 (estimated)
Last update
Jul 22, 2020

Study contacts

Smadar Shilo, Dr
Contact
smadar.shilo@weizmann.ac.il
89344307

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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