Crohn's DiseasePhase 2NCT01647412
Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease
A Phase 2 study testing Growth Hormone, Nutraceutical Combination and Exclusion Diet in people with Crohn's Disease, run by Columbia University at 1 site in United States.
Trial summary
Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately 20-30% develop this condition during childhood or adolescence, most of whom have Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Growth Hormone, Nutraceutical Combination and Exclusion Diet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to not given
- Phase
- Phase 2
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ability to provide written informed consent
- Age 10-17 years
- Diagnosis of CD as determined by standard clinical, radiological, and pathological criteria
- Clinical evidence of CD for more than 2 years
- Moderate to severely active CD, as defined by a PCDAI score > 30 and < 65
- May continue use of aminosalicylates, antibiotics, immunomodulators, including azathioprine, 6-mercaptopurine and methotrexate, as well as the monoclonal antibody drug, infliximab, if prescribed for at least 4 months and receiving stable doses for at least 2 months prior to baseline visit
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- May continue the use of prednisone if prescribed for at least 6 weeks prior to baseline visit
- Meets the following hematological and biochemical requirements:
- HGB > 8.5 g/dl
- WBC > 3.5 x 109/L
- Neut. > 1.5 x 109
- Plats > 100 x 109/L
- SGOT \& Alk Phos not > 2 times the upper limit of normal
Who cannot join
- Acute critical illness
- Acute, chronic, or latent infection
- Active neoplasia and/or history of neoplastic disease of any origin other than basal cell carcinoma that has been removed
- Evidence of a systemic disorder unrelated to CD involving hepatic, gastrointestinal, pulmonary, cardiac, renal, hematologic, endocrine, central or peripheral nervous systems
- Use of parenteral corticosteroids or corticotrophin within 2 months of baseline visit
- Use of another investigational agent within 3 months of baseline visit
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- Long-term anti-coagulant therapy or use of any anti-coagulant medication, including NSAIDs or ASA, within 2 weeks of screening visit
- Pregnancy (positive pregnancy test)
- Positive stool culture for enteric pathogens, pathogenic ova, parasites or clostridium difficile toxin
- Any condition that the investigator believes would pose significant harm to the subject if the investigational therapy were initiated
- Diagnosis of short bowel syndrome and also on TPN
- Presence of an ostomy, symptomatic stenosis or ileal stricture, or severe intestinal stricture, proctocolectomy, total colectomy or stoma
- Patients in imminent need of surgery due to active gastrointestinal bleeding fixed stenosis, intermittent obstruction or obstructive event within 2 months prior to screening.
- Patients who underwent CD surgery within 2 months of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Department of Clinical Genetics
New York, New York, 10032
About this study
Official title: Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial
Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately 20-30% develop this condition during childhood or adolescence, most of whom have Crohn's disease (CD). It appears that some individuals are genetically susceptible to certain nutrients, causing inflammation and disturbance of their immune system, as well as disruption of the intestinal barrier. This leads to malnutrition and inhibited growth, with many patients experiencing intense abdominal pain and diarrhea.
Most physicians treat the disease with drugs that suppress the immune system and decrease the inflammatory process. Although these drugs frequently induce remission, most patients experience a subsequent return of symptoms and fail to catch up on their growth. Additionally, serious side effects are associated with these drugs.
Read more
Individuals genetically prone to CD are believed to have a leaky gut that allows substances to pass through the intestinal wall and react with the underlying immune system. Furthermore, those nutrients that are toxic to these individuals pass through the decreased intestinal barrier triggering an extreme immune response. Nutrients that have been implicated include grains, except rice, dairy products, and any food containing carrageenan. Excluding these nutrients from the diet has been shown to beneficial for CD patients. Certain nutraceuticals, such as curcumin and omega-3 fatty acids, have been shown to provide anti-inflammatory effects in IBD patients. In addition, the administration growth hormone (GH), has been shown to alleviate symptoms, by enhancing the repair of the intestinal epithelium, preventing toxic antigens from reaching the underlying lamina propria.
Previous studies and case reports provide incomplete evidence that exclusion diet with nutraceuticals (DNT) and GH lead to sustained long term remission in juvenile CD, discontinuation of other CD drugs, and catch up growth. This study is designed to test this hypothesis. Patients in the treatment group will be treated with DNT and GH, while continuing to receive medications from their physician while the control group will receive DNT, placebo injections instead of GH. We predict that the treatment group will show greater improvement than the control group.
Read the detailed description
The most widely held hypothesis regarding the pathogenesis of inflammatory bowel disease (IBD) is that overly aggressive acquired immune responses to a subset of commensal enteric bacteria develop in genetically susceptible hosts. In an attempt to avoid disease progression, patients are treated with anti-inflammatory, immunomodulatory and monoclonal antibody drugs, which frequently produce remissions. However, these drugs usually fail to achieve long-term, sustained remission or reversal of growth failure, and are associated with serious side effects. Recently, intestinal barrier dysfunction has been implicated in an alternative 3-step model of IBD pathogenesis.
The investigators hypothesize that the exclusion diet and nutraceutical therapy (DNT) will decrease the production of toxic antigens in the gut and that reactive human growth hormone (rhGH) will reduce the passage of the remaining toxic antigens to the underlying mucosal immune system by promoting the maintenance of the intestinal barrier and accelerating the restitution of the intestinal epithelial lining.
The following study will test whether the the 3-step model is accurate, and whether rhGH and DNT will induce sustained remission in juvenile CD patients.
- Conditions
- Crohn's Disease
- Being tested
- Growth Hormone, Nutraceutical Combination, Exclusion Diet, Placebo Growth Hormone
- Keywords
- Crohn's disease, Inflammatory Bowel Disease, Growth Hormone, Nutraceuticals
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth HormoneDrug
Humatrope will be administered daily to patients in a dose of .18-.20 mg/kg/week.
Nutraceutical CombinationDietary supplement
Also called Jarrow Curcumin oral capsule bid, Jarrow Max DHA (Fish oil) oral capsule daily, Culturelle Probiotics oral capsule tw, Intestive oral capsule bid
Exclusion DietOther
Patients on the exclusion diet will adhere from consumption of all grain, corn, dairy, and carrageenan containing products.
Placebo Growth HormoneOther
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormone, Exclusion Diet, and Nutraceutical therapy | Active comparator | The experimental group will receive the exclusion diet and nutraceutical therapy (DNT) and daily subcutaneously administered recombinant human growth hormone (rhGH) for the first 26 weeks. After 26 weeks this group will continue on the exclusion diet nutraceutical therapy for the remaining 26 weeks of the study. Receives: Drug: Growth Hormone; Dietary Supplement: Nutraceutical Combination; Other: Exclusion Diet |
| rhGH placebo, Exclusion diet, and nutraceutical therapy | Placebo comparator | The experimental group will receive the exclusion diet and nutraceutical therapy (DNT) and daily subcutaneously administered placebo injections for the first 26 weeks. After 26 weeks this group will continue on the exclusion diet and nutraceutical therapy for the remaining 26 weeks of the study. Receives: Dietary Supplement: Nutraceutical Combination; Other: Exclusion Diet; Other: Placebo Growth Hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients in remission
The proportion of patients in remission in each group will be assessed and compared to each other in order to demonstrate efficacy of treatment. Remission will be assessed by a change in the patients PCDAI score to below 10.
Measured: 26 weeks and 52 weeks
Secondary outcomes (1)
Bone Mineral Density (BMD)
BMD of the hip and spine will be obtained by dual-emission x-ray absorptiometry (DXA) at the baseline visit and week 52.
Measured: Baseline and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startMar 2012
Why it stopped: PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred E Slonim, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647412
- Sponsor's protocol ID
- AAAJ8306
- Status last verified
- Apr 2015
- First submitted
- 19 Jul 2012
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01647412
- Acronym / sponsor ID
- AAAJ8306
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Inflammatory Bowel Disease, Growth Hormone, Nutraceuticals
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- Mar 2012
- First posted
- 23 Jul 2012 (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.
Of the estimated one million Americans with inflammatory bowel disease (IBD), approximately 20-30% develop this condition during childhood or adolescence, most of whom have Crohn's disease (CD). It appears that some individuals are genetically susceptible to certain nutrients, causing inflammation and disturbance of their immune system, as well as disruption of the intestinal barrier. This leads to malnutrition and inhibited growth, with many patients experiencing intense abdominal pain and diarrhea.
Most physicians treat the disease with drugs that suppress the immune system and decrease the inflammatory process. Although these drugs frequently induce remission, most patients experience a subsequent return of symptoms and fail to catch up on their growth. Additionally, serious side effects are associated with these drugs.
Individuals genetically prone to CD are believed to have a leaky gut that allows substances to pass through the intestinal wall and react with the underlying immune system. Furthermore, those nutrients that are toxic to these individuals pass through the decreased intestinal barrier triggering an extreme immune response. Nutrients that have been implicated include grains, except rice, dairy products, and any food containing carrageenan. Excluding these nutrients from the diet has been shown to beneficial for CD patients. Certain nutraceuticals, such as curcumin and omega-3 fatty acids, have been shown to provide anti-inflammatory effects in IBD patients. In addition, the administration growth hormone (GH), has been shown to alleviate symptoms, by enhancing the repair of the intestinal epithelium, preventing toxic antigens from reaching the underlying lamina propria.
Previous studies and case reports provide incomplete evidence that exclusion diet with nutraceuticals (DNT) and GH lead to sustained long term remission in juvenile CD, discontinuation of other CD drugs, and catch up growth. This study is designed to test this hypothesis. Patients in the treatment group will be treated with DNT and GH, while continuing to receive medications from their physician while the control group will receive DNT, placebo injections instead of GH. We predict that the treatment group will show greater improvement than the control group.
Detailed description
The most widely held hypothesis regarding the pathogenesis of inflammatory bowel disease (IBD) is that overly aggressive acquired immune responses to a subset of commensal enteric bacteria develop in genetically susceptible hosts. In an attempt to avoid disease progression, patients are treated with anti-inflammatory, immunomodulatory and monoclonal antibody drugs, which frequently produce remissions. However, these drugs usually fail to achieve long-term, sustained remission or reversal of growth failure, and are associated with serious side effects. Recently, intestinal barrier dysfunction has been implicated in an alternative 3-step model of IBD pathogenesis.
The investigators hypothesize that the exclusion diet and nutraceutical therapy (DNT) will decrease the production of toxic antigens in the gut and that reactive human growth hormone (rhGH) will reduce the passage of the remaining toxic antigens to the underlying mucosal immune system by promoting the maintenance of the intestinal barrier and accelerating the restitution of the intestinal epithelial lining.
The following study will test whether the the 3-step model is accurate, and whether rhGH and DNT will induce sustained remission in juvenile CD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormone, Exclusion Diet, and Nutraceutical therapy | Active comparator | Drug: Growth Hormone, Dietary Supplement: Nutraceutical Combination, Other: Exclusion DietThe experimental group will receive the exclusion diet and nutraceutical therapy (DNT) and daily subcutaneously administered recombinant human growth hormone (rhGH) for the first 26 weeks. After 26 weeks this group will continue on the exclusion diet nutraceutical therapy for the remaining 26 weeks of the study. |
| rhGH placebo, Exclusion diet, and nutraceutical therapy | Placebo comparator | Dietary Supplement: Nutraceutical Combination, Other: Exclusion Diet, Other: Placebo Growth HormoneThe experimental group will receive the exclusion diet and nutraceutical therapy (DNT) and daily subcutaneously administered placebo injections for the first 26 weeks. After 26 weeks this group will continue on the exclusion diet and nutraceutical therapy for the remaining 26 weeks of the study. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Ability to provide written informed consent
- Age 10-17 years
- Diagnosis of CD as determined by standard clinical, radiological, and pathological criteria
- Clinical evidence of CD for more than 2 years
- Moderate to severely active CD, as defined by a PCDAI score > 30 and < 65
Key exclusion criteria (14 listed)
- Acute critical illness
- Acute, chronic, or latent infection
- Active neoplasia and/or history of neoplastic disease of any origin other than basal cell carcinoma that has been removed
- Evidence of a systemic disorder unrelated to CD involving hepatic, gastrointestinal, pulmonary, cardiac, renal, hematologic, endocrine, central or peripheral nervous systems
- Use of parenteral corticosteroids or corticotrophin within 2 months of baseline visit
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 |
|---|---|---|
| Growth HormoneHumatrope will be administered daily to patients in a dose of .18-.20 mg/kg/week. | Drug | Growth Hormone, Exclusion Diet, and Nutraceutical therapy |
| Nutraceutical CombinationAlso: Jarrow Curcumin oral capsule bid, Jarrow Max DHA (Fish oil) oral capsule daily, Culturelle Probiotics oral capsule tw, Intestive oral capsule bid | Dietary supplement | Growth Hormone, Exclusion Diet, and Nutraceutical therapy, rhGH placebo, Exclusion diet, and nutraceutical therapy |
| Exclusion DietPatients on the exclusion diet will adhere from consumption of all grain, corn, dairy, and carrageenan containing products. | Other | Growth Hormone, Exclusion Diet, and Nutraceutical therapy, rhGH placebo, Exclusion diet, and nutraceutical therapy |
| Placebo Growth Hormone | Other | rhGH placebo, Exclusion diet, and nutraceutical therapy |
Primary outcome
Proportion of Patients in remission
Time frame: 26 weeks and 52 weeks
The proportion of patients in remission in each group will be assessed and compared to each other in order to demonstrate efficacy of treatment. Remission will be assessed by a change in the patients PCDAI score to below 10.
1 secondary outcome
Bone Mineral Density (BMD)
Time frame: Baseline and 52 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2015.
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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.
Alfred E Slonim, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Growth Hormone, Nutraceutical Combination and Exclusion Diet in people with Crohn's Disease, run by Columbia University at 1 site in United States.
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 13 inclusion and 14 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: withdrawn, as of the sponsor's last update on 13 Apr 2015. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients in remission (time frame: 26 weeks and 52 weeks). 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 13 Apr 2015.