NCT03327207

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

4 years

First QC Date

October 25, 2017

Last Update Submit

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

Other: Non Interventional

Control group

Healthy children . Non Interventional

Other: Non Interventional

Interventions

Non Interventional

Control groupStudy group

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Pediatric endocrinology unit rambam medical center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

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

Locations