Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 10 - 17 |
| Updated: | 3/16/2015 |
| Start Date: | January 2013 |
| Contact: | Alfred E Slonim, MD |
| Email: | as2718@columbia.edu |
| Phone: | 212-305-5717 |
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.
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.
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.
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.
(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.
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
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