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Pediatric Crohn’s Disease

What is Pediatric Crohn’s Disease?

Pediatric Crohn’s Disease refers to the onset of Crohn’s disease in children and young adults. Early onset of the disease is associated with an increased involvement of both the upper and lower GI tract in the disease.

Inflammation of the GI tract causes recurring “flares” of disease severity which are associated with abdominal pain, poor absorption of nutrition, diarrhea, nausea and rectal bleeding. The inflammation can cause strictures and malformation of the GI tract which may require corrective surgery. Flares may recur over a period of weeks to years, depending on the specific individual.

Some Quick Facts

  • About half of all Pediatric Crohn’s patients have inflammation of both the upper and lower GI tract
  • The younger the age of onset for pediatric Crohn’s is, the more likely there is to be a family history of inflammatory bowel disease (IBD)
  • Occurrence of Crohn’s disease in pediatric patients is associated with genetic mutations in both the innate and adaptive immune system
  • The incidence of IBD in general, and Crohn’s in particular, has been broadly increasing over the last 50 years, particularly in the developed world, suggesting a role for the “sanitary hypothesis” – that is, while sanitary conditions improve, immune-mediated disease also increases
  • Pediatric Crohn’s Disease is 2x more likely than ulcerative colitis in pediatric patients with inflammatory bowel disease
  • There are  over 50,000 total cases of pediatric IBD in North America and 4,500 new cases annually

More information on Pediatric Crohn’s Disease can be found at Cedars Sinai.

Symptoms of Pediatric Crohn’s Disease

Symptoms of Pediatric Crohn’s Disease include:

  • Abdominal pain
  • Diarrhea, sometimes bloody
  • Rectal bleeding
  • Weight loss
  • Fever
  • Delayed growth
  • Joint pain
  • Skin rashes

Disease symptoms may come and go with disease remission.

Disease progression may be associated with malformation of the gastrointestinal tract that requires surgery to ameliorate.

More information on Pediatric Crohn’s disease can be found in our Reference Literature.

Treatment Options

Disease “flares” are primarily treated with either corticosteroid or biological anti-inflammatory agents. Other agents may be used as maintenance therapy between flares.

There is NO approved therapy for mild to moderate disease flares. Treatment is limited to off-label use of steroids and other anti-inflammatory treatments and second-line use of biologics.

Prednisone (steroid) Treatment

When changes in nutrition and lifestyle are inadequate to control disease flares, immediate treatment is often initiated with high doses of prednisone.

Prednisone is a steroid that helps to control the inflammation. However, steroids have a number of associated side effects, including causing high blood pressure, glucose intolerance, reduced bone mass, cataracts, decreased growth and increased risk of infections. Some of these side effects further exacerbate complications from the disease itself such as lack of growth. Because the prednisone can reach all areas of the body (systemically), all these side effects occur. Due to the severity of side effects, treatment is kept as minimal as possible.

Unfortunately, steroid use can also lead to steroid dependence, such that stopping treatment with the steroids results in immediate disease flare ups.

Biological Treatment

There are two FDA approved treatments for severe disease that have failed conventional (e.g., steroid) therapy. These treatments suppress specific inflammatory signaling in the body.

Both products are associated with BLACK BOX warnings for causing cancer (e.g., lymphoma) and increasing risk of life-threatening infection.

Where Soligenix Comes in

SGX203 is an alternative steroid anti-inflammatory treatment for Pediatric Crohn’s Disease flares. The active ingredient in SGX203 is beclomethasone dipropionate (BDP), a very well-characterized steroid that has a reduced ability to cross into the bloodstream.

By administering BDP as a 2-tablet system, with one tablet dissolving in the stomach and one in the lower intestine, a topical coating of BDP throughout the GI tract can be achieved,  providing direct anti-inflammatory action where it is needed while reducing the penetration of the steroid to the blood stream. This may reduce the toxicity of steroid treatment, while maintaining the steroid activity where it is needed.

Helpful Resources

Information on Pediatric Crohn’s disease progression and treatment options is also available at the following sites: