Growth Hormone DeficiencyNCT03327207
Exploring Interactions Between Growth Hormone and the Microbiome
An observational study of Growth Hormone Deficiency, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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 Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Growth Hormone Deficiency
- What is being tested?
- Non Interventional
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Child, Adult
Study population: Children with GH deficiency
Who may be able to join
- Children with GH deficiency
Who cannot join
- Turner syndrome
- End state renal disease (ESRD)
- Prader-Willi syndrome
- Systemic illness
- Antibiotics/Antifungal in the last 3m
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pediatric endocrinology unit rambam medical center
Haifa
Smadar Shilo, MD, 97247774400
About this study
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
- Conditions
- Growth Hormone Deficiency
- Being tested
- Non Interventional
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non InterventionalOther
Non Interventional
| Study group | Role | What they receive |
|---|---|---|
| Study group | Children who receive Growth hormone treatment. Non Interventional Receives: Other: Non Interventional | |
| Control group | Healthy children . Non Interventional Receives: Other: Non Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the microbiome population following Growth hormone treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2017
- Study start1 Nov 2017
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Weizmann Institute of Science
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03327207
- Sponsor's protocol ID
- 0132-17 RMB CTIL
- Status last verified
- Jul 2020
- First submitted
- 25 Oct 2017
- Last updated
- 22 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Interactions Between Growth Hormone and the Microbiome
- ClinicalTrials.gov ID
- NCT03327207
- Acronym / sponsor ID
- 0132-17 RMB CTIL
- Conditions
- Growth Hormone Deficiency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Weizmann Institute of Science
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 31 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Non InterventionalChildren who receive Growth hormone treatment. Non Interventional |
| Control group | – | Other: Non InterventionalHealthy children . Non Interventional |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with GH deficiency
Key inclusion criteria (1 listed)
- Children with GH deficiency
Key exclusion criteria (5 listed)
- Turner syndrome
- End state renal disease (ESRD)
- Prader-Willi syndrome
- Systemic illness
- Antibiotics/Antifungal in the last 3m
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non InterventionalNon Interventional | Other | Control group, Study group |
Primary outcome
Changes in the microbiome population following Growth hormone treatment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Growth Hormone Deficiency
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Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
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Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Hormone Deficiency, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Smadar Shilo, Dr (89344307, smadar.shilo@weizmann.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the microbiome population following Growth hormone treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.