Crohn DiseasePhase 4NCT00609752
Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
A Phase 4 study testing prednisolone and Alicalm (polymeric liquid formula) in people with Crohn Disease, run by University Hospital Birmingham at 6 sites in United Kingdom.
Trial summary
This study will compare two current first-line treatments for childhood Crohn's Disease, steroids versus a liquid diet, and determine the effects of these treatments on bone health, quality of life and treatment efficacy. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- prednisolone and Alicalm (polymeric liquid formula)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Feb 2008to Jan 2010
- Phase
- Phase 4
- 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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Active Crohn's Disease with PCDAI > 20
- Aged 7 - 17 with possibility of 1 year follow-up
Who cannot join
- Previous treatment for Crohn's Disease with liquid diet or glucocorticoid therapy
- Isolated orofacial granulomatosis
- Intravenous glucocorticoid therapy immediately indicated
- Planned surgical intervention for CD
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites, 6 recruiting
- Recruiting
Birmingham Children's Hospital
Birmingham, West Midlands, B4 6NH
Kelly Spencer, +44 (0)121 333 9542, k.spencer@bham.ac.uk
M Stephen Murphy
- Recruiting
Bristol Royal Hospital for Sick Children
Bristol, Bristol, BS2 8BJ
Christine Spray
- Recruiting
Royal Liverpool Children's Hospital
Liverpool, Merseyside, L12 2AP
Mark Dalzell
- Recruiting
St George's University Hospital
London, London, SW17 0QT
Sally Mitton
- Recruiting
Oxford Children's Hospital
Oxford, Oxfordshire, OX3 9DZ
Astor Rodrigues
- Recruiting
Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 2TH
Christopher Taylor
About this study
This study will compare two current first-line treatments for childhood Crohn's Disease, steroids versus a liquid diet, and determine the effects of these treatments on bone health, quality of life and treatment efficacy.
Read the detailed description
Crohn's Disease is a very serious inflammatory gut disorder that often first presents in childhood. Once present, the underlying condition remains for life. It usually responds well to medical treatment which brings about a disease 'remission' but is inclined to become active again at intervals (relapses). When it is active, children are very unwell with reduced energy, loss of appetite and distressing abdominal symptoms (pain, diarrhea, etc.). Active disease can be treated in two very different ways - either with a 3-month course of steroids (tablets), or with a 6-week course of so called "liquid diet therapy (LDT)." With LDT, children receive all of their nutrition in liquid form. Both treatments have advantages and disadvantages. Both are quite effective, often controlling symptoms within days. Steroids may cause various side effects including thinning of bones (osteoporosis) with increased risk of fractures. LDT is somewhat challenging because normal (solid) foods are not allowed during the period of treatment. Both steroids and LDT are widely used - steroids predominately in the USA and LDT elsewhere. There is controversy as to which is best. This study aims to determine which should be preferred.
In this clinical study, children presenting with Crohn's disease will be randomly assigned to either steroid treatment or LDT and followed up for a period of one year. During that time the assigned treatment will be used for any episodes of active disease. We will study a total of 80 children attending the Paediatric Gastroenterology Units in Birmingham, Bristol, Liverpool, Oxford, Sheffield and St. George's Hospital in London. Various outcomes will be compared in the two groups. We will examine the recovery rates (success in bringing about remission) and the frequency of subsequent relapses. We will compare growth and physical development, because active Crohn's disease and possibly steroids may have adverse effects on these processes. A special focus of the study will be on the effect of the disease and its treatment on bone health. Using special blood and urine tests and bone scans we will compare bone growth and density in the two groups. Finally, it is crucially important that we consider the impact of the disease and its treatment on the young person on the basis of their own individual perspective. To do this we will compare the 'quality of life' of children in the two treatment groups, using a questionnaire specially designed to measure this aspect in young people with Crohn's disease.
This study will thus enable us to undertake a comprehensive comparison of the two major first-line treatments used in childhood Crohn's Disease. This is crucially important, and no such study has previously been undertaken
- Conditions
- Crohn Disease
- Being tested
- prednisolone, Alicalm (polymeric liquid formula)
- Keywords
- Crohn Disease, Children, Bone Density, Prednisolone, Liquid Diet Therapy, Quality of Life, Metabolic Bone Disease
- Medical subject headings
- Crohn Disease, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prednisoloneDrug
Standard treatment regimens based on body weight will be used (approximately 2 mg per kg), with a stepwise dose reduction over a 10-14 week period.
Alicalm (polymeric liquid formula)Dietary supplement
Also called Alicalm (SHS International Ltd.)
Subjects will receive all of their nutritional requirements in the form of a nutritionally balanced polymeric feed, volume based on EAR for age. Duration of 5 to 8 weeks with subjects returning to a "normal" unrestricted diet by 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: prednisolone |
| 2 | Active comparator | Not described Receives: Dietary Supplement: Alicalm (polymeric liquid formula) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone mineral density change based on DXA measurement at 1 year
Measured: 12 months post-recruitment
Secondary outcomes (9)
Proportion in remission
Measured: 6 weeks
Change in PCDAI, HAB and pHBS
Measured: 6 weeks
Quality of life throughout treatment period, using IMPACT III measurements
Measured: 12 months
Baseline urine 11B-HSD1 and bone formation
Measured: 6 weeks
Baseline urine 11B-HSD1 activity and change in bone mineral density
Measured: 12 months
Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST
Measured: 12 months
Growth impairment
Measured: 12 months
Adherence to randomised therapy for relapses
Measured: 12 months
Adverse effects
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2010 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- SHS International, Children's Memorial Research Foundation, St George's University Hospitals NHS Foundation Trust
- Investigators
- M. Stephen Murphy, Study director, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609752
- Sponsor's protocol ID
- RG_06_266
- Other IDs
- EudraCT: 2006-000209-48, CTA: 21761/0213/001
- Status last verified
- Dec 2008
- First submitted
- 24 Jan 2008
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Effects of Glucocorticoid Therapy on Bone in Childhood Crohn's Disease
- ClinicalTrials.gov ID
- NCT00609752
- Acronym / sponsor ID
- RG_06_266
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Children, Bone Density, Prednisolone, Liquid Diet Therapy, Quality of Life, Metabolic Bone Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- SHS International, Children's Memorial Research Foundation, St George's University Hospitals NHS Foundation Trust
- Study start
- Feb 2008
- Primary completion
- Jan 2010 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 7 Feb 2008 (estimated)
- 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.
This study will compare two current first-line treatments for childhood Crohn's Disease, steroids versus a liquid diet, and determine the effects of these treatments on bone health, quality of life and treatment efficacy.
Detailed description
Crohn's Disease is a very serious inflammatory gut disorder that often first presents in childhood. Once present, the underlying condition remains for life. It usually responds well to medical treatment which brings about a disease 'remission' but is inclined to become active again at intervals (relapses). When it is active, children are very unwell with reduced energy, loss of appetite and distressing abdominal symptoms (pain, diarrhea, etc.). Active disease can be treated in two very different ways - either with a 3-month course of steroids (tablets), or with a 6-week course of so called "liquid diet therapy (LDT)." With LDT, children receive all of their nutrition in liquid form. Both treatments have advantages and disadvantages. Both are quite effective, often controlling symptoms within days. Steroids may cause various side effects including thinning of bones (osteoporosis) with increased risk of fractures. LDT is somewhat challenging because normal (solid) foods are not allowed during the period of treatment. Both steroids and LDT are widely used - steroids predominately in the USA and LDT elsewhere. There is controversy as to which is best. This study aims to determine which should be preferred.
In this clinical study, children presenting with Crohn's disease will be randomly assigned to either steroid treatment or LDT and followed up for a period of one year. During that time the assigned treatment will be used for any episodes of active disease. We will study a total of 80 children attending the Paediatric Gastroenterology Units in Birmingham, Bristol, Liverpool, Oxford, Sheffield and St. George's Hospital in London. Various outcomes will be compared in the two groups. We will examine the recovery rates (success in bringing about remission) and the frequency of subsequent relapses. We will compare growth and physical development, because active Crohn's disease and possibly steroids may have adverse effects on these processes. A special focus of the study will be on the effect of the disease and its treatment on bone health. Using special blood and urine tests and bone scans we will compare bone growth and density in the two groups. Finally, it is crucially important that we consider the impact of the disease and its treatment on the young person on the basis of their own individual perspective. To do this we will compare the 'quality of life' of children in the two treatment groups, using a questionnaire specially designed to measure this aspect in young people with Crohn's disease.
This study will thus enable us to undertake a comprehensive comparison of the two major first-line treatments used in childhood Crohn's Disease. This is crucially important, and no such study has previously been undertaken
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: prednisolone |
| 2 | Active comparator | Dietary Supplement: Alicalm (polymeric liquid formula) |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Active Crohn's Disease with PCDAI > 20
- Aged 7 - 17 with possibility of 1 year follow-up
Key exclusion criteria (4 listed)
- Previous treatment for Crohn's Disease with liquid diet or glucocorticoid therapy
- Isolated orofacial granulomatosis
- Intravenous glucocorticoid therapy immediately indicated
- Planned surgical intervention for CD
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 |
|---|---|---|
| prednisoloneStandard treatment regimens based on body weight will be used (approximately 2 mg per kg), with a stepwise dose reduction over a 10-14 week period. | Drug | 1 |
| Alicalm (polymeric liquid formula)Also: Alicalm (SHS International Ltd.)Subjects will receive all of their nutritional requirements in the form of a nutritionally balanced polymeric feed, volume based on EAR for age. Duration of 5 to 8 weeks with subjects returning to a "normal" unrestricted diet by 10 weeks. | Dietary supplement | 2 |
Primary outcome
Bone mineral density change based on DXA measurement at 1 year
Time frame: 12 months post-recruitment
9 secondary outcomes
Proportion in remission
Time frame: 6 weeks
Change in PCDAI, HAB and pHBS
Time frame: 6 weeks
Quality of life throughout treatment period, using IMPACT III measurements
Time frame: 12 months
Baseline urine 11B-HSD1 and bone formation
Time frame: 6 weeks
Baseline urine 11B-HSD1 activity and change in bone mineral density
Time frame: 12 months
Change in urine 11B-HSD1 activity and PCDAI in patients before and after treatment with LDT and CST
Time frame: 12 months
Growth impairment
Time frame: 12 months
Adherence to randomised therapy for relapses
Time frame: 12 months
Adverse effects
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2008.
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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.
M. Stephen Murphy study director
University of Birmingham
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing prednisolone and Alicalm (polymeric liquid formula) in people with Crohn Disease, run by University Hospital Birmingham at 6 sites in United Kingdom.
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 2 inclusion and 4 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 30 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 M. Stephen Murphy (+44 (0)121 333 8705, m.s.murphy@bham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone mineral density change based on DXA measurement at 1 year (time frame: 12 months post-recruitment). 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 30 Dec 2008.