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Crohn’s Disease Tissue and Plasma Samples

by | Mar 18, 2022 | News Releases | 0 comments

Bay Biosciences provides high-quality biopsy tissue samples, formalin fixed paraffin embedded (FFPE) tissue blocks, with matched fresh frozen sera (serum), plasma, and peripheral blood mononuclear cells (PBMC) bio-fluids, from patients diagnosed with Chron’s disease.

The sera (serum), plasma and peripheral blood mononuclear cells (PBMC) biofluid specimens are processed from patients peripheral whole-blood using customized collection and processing protocols from Chron’s disease.

Fresh frozen tissue and matched biofluid samples were, collected from unique patients diagnosed with Chron’s disease.

Bio-samples are provided to a valued pharmaceutical customer for research, diagnostics, discovery, and drug development.

Chron’s Disease Overview

Chron’s disease is a chronic, or long-term, disease that causes inflammation in the digestive tract. It can be painful, debilitating, and sometimes life threatening.

It primarily causes ulcerations (breaks in the mucosal lining) of the small and large intestines, but can affect the digestive system anywhere from the mouth to the anus.

Chron’s disease is also called granulomatous enteritis or colitis, regional enteritis, ileitis, or terminal ileitis.

It is an autoimmune-mediated Inflammatory condition. It can affect any part of the gastrointestinal (GI) tract, from the mouth to the anus.

The disease primarily involves the intestinal system, but it also has a variety of other manifestations and can affect the skin, joints, bones, eyes, kidney, and liver.

Symptoms of Chron’s disease can include intestinal ulcers, discomfort, and pain.

Although it typically starts in childhood or early adulthood, it can develop at any age.


Signs and Symptoms of Chron’s Disease

Symptoms of Chron’s disease vary, depending on which part of the gut the condition affects. These usually include the following:

  • Pain: The level of pain varies from patient-to-patient and depends on where the inflammation is in the gut. Usually patients tend to experience pain in the lower right side of the abdomen.
  • Ulcers in the gut: These are raw areas that may bleed. If this happens, a person may find blood in the stools.
  • Mouth ulcers: These are a common symptom.
  • Diarrhea: This can range from mild to severe, and there may be mucus, blood, or pus. A person may also feel the urge to have a bowel movement but find that nothing comes out.
  • Fatigue: People with Crohn’s disease often feel very tired, and they may have a fever.
  • Altered appetite: At times, a person may experience appetite loss.
  • Weight loss: This can result from a loss of appetite.
  • Anemia: A loss of blood can lead to anemia.
  • Rectal bleeding and anal fissures: The skin of the anus becomes cracked, leading to pain and bleeding.

During a flare of Chron’s disease symptoms, a person may also develop:


Chron’s Disease Symptoms in Female Patients

About half of female patients who develop Chron’s disease do so before the age of 35. It can have some specific symptoms in females, such as the following:

  • Discomfort about sex, as Chron’s disease can affect the patient’s libido and body image, as well as causing pain and other types of discomfort
  • Irregular menstruation, due to effects on hormone function
  • Pain during sex, if symptoms affect areas near the anus or vagina
  • Iron deficiency, as Chron’s disease affects the absorption of nutrients and can lead to intestinal bleeding

Chron’s disease does not appear to affect fertility, but research suggests that it is harder to conceive when the disease is active and after surgery.

Having an inflammatory bowel disease (IBD), such as Chron’s disease, does not keep a person from becoming pregnant. However, someone with this type of disease is more likely to:

  • Have a preterm delivery
  • Need a cesarean delivery
  • Give birth to an infant with a low birth weight

Symptoms for Each Type of Chron’s Disease

The symptoms of Crohn’s disease are dependent on the location, the extent, and the severity of the inflammation. The different subtypes of Crohn’s disease and their symptoms are:

  • Crohn’s colitis is inflammation that is confined to the colon. Abdominal pain and bloody diarrhea are the common symptoms. Anal fistulae and perirectal abscesses also can occur. 

 

  • Crohn’s enteritis refers to inflammation confined to the small intestine (the second part, called the jejunum or the third part, called the ileum). Involvement of the ileum alone is referred to as Crohn’s ileitis. Abdominal pain and diarrhea are the common symptoms. Obstruction of the small intestine also can occur.

 

  • Crohn’s terminal ileitis is inflammation that affects only the very end of the small intestine (terminal ileum), the part of the small intestine closest to the colon. Abdominal pain and diarrhea are the common symptoms. Small intestinal obstruction also can occur.

 

  • Crohn’s enterocolitis and ileocolitis are terms to describe Inflammation that involve both the small intestine and the colon. Bloody diarrhea and abdominal pain are the common symptoms. Small intestinal obstruction also can occur.

 

  • Crohn’s terminal ileitis and ileocolitis are the most common types of Chron’s disease. (Ulcerative colitis frequently involves only the rectum or rectum and sigmoid colon at the distal end of the colon. These are called ulcerative proctitis and procto-sigmoiditis, respectively.)

Other Symptoms of Chron’s Disease

Up to one-third of patients with Chron’s disease may have one or more of these conditions, symptoms, and signs that involve the anal area affected.

  • Swelling of the tissue of the anal sphincter, the muscle at the end of the colon that controls defecation.
  • Development of ulcers and fissures (long ulcers) within the anal sphincter. These ulcers and fissures can cause bleeding and pain with defecation.
  • Development of anal fistulae (abnormal tunnels) between the anus or rectum and the skin surrounding the anus). Mucous and pus may drain from the openings of the fistulae on the skin.
  • Development of perirectal abscesses (collections of pus in the anal and rectal area). Peri-rectal abscesses can cause fever, pain and tenderness around the anus.

Causes of Chron’s Disease

It is unknown what causes Chron’s disease. Scientists suggest that it may stem from an abnormal reaction of the immune system. However, they do not know whether this reaction causes the disease or results from it.

Some scientists suspect that infection by certain bacteria, such as strains of mycobacterium, may be the cause of Chron’s disease. 

Diet may affect the symptoms of Chron’s disease; however, it is unlikely that diet is responsible for causing the disease. Abdominal pain and diarrhea are the common symptoms. Obstruction of the small intestine also can occur. Crohn’s disease is not contagious.

Factors that may increase the risk of inflammation include the following:

  • A patient’s immune system
  • Environmental factors
  • Genetic factors

A bacterium or virus may also play a role. For example, research suggests that there is a link between the bacterium Escherichia coli and Chron’s disease.


Immune System

  • Activation of the immune system in the intestines appears to be important in inflammatory Bowel Disease(IBD). In individuals with IBD, the immune system is abnormally and chronically activated in the absence of any known invader. This results in chronic inflammation and ulceration.


Genetics

  • The susceptibility to abnormal activation of the immune system is genetically inherited. Thus, first degree relatives (brothers, sisters, children, and parents) of people with IBD are more likely to develop these diseases.

Recently a gene called NOD2 has been identified as being associated with Crohn’s disease. This gene is important in determining how the body responds to some bacterial products.

Patients with mutations in this gene are more susceptible to developing Crohn’s disease.

Other genes are still being discovered and studied which are important in understanding the pathogenesis of Crohn’s disease. This includes autophagy related 16-like 1 gene (ATG 16L1) and IRGM, which both contribute to macrophage defects and have been identified with the Genome-Wide Association study.


Bacteria

  • There also have been studies which show that in the intestines of individuals with Crohn’s disease, there are higher levels of a certain type of bacterium, E. Coli, which might play a role in the disease.

 

Diagnosis of Chron’s Disease

There is no specific diagnostic test for Crohn’s disease. A doctor will ask a person about their symptoms. A physical examination may reveal a lump in the abdomen resulting from when loops of inflamed bowels became stuck together.

The following diagnostic tests are performed to diagnose Chron’s disease:

  • Blood tests
  • Biopsy
  • Colonoscopy, which involves using a flexible, tube-like tool, a colonoscope, to investigate the colon
  • Endoscopy, which involves inserting a long, thin, flexible tool called an endoscope down through the esophagus and into the stomach to investigate the upper part of the gut
  • CT scan or barium enema X-ray, which help reveal changes in the bowel
  • sigmoidoscopy, which involves using a short, flexible, tube-like tool, a sigmoidoscopy, to investigate the lower bowel
  • Stool tests


Laboratory blood tests may show elevated white blood cell counts and sedimentation rates, both of which suggest infection or inflammation. Other blood tests may show low red blood cell counts (anemia), low blood proteins, and low body minerals, reflecting loss of these minerals due to chronic diarrhea.

Barium X-ray studies can be used to define the distribution, nature, and severity of the disease. Barium is a chalky material that is visible by X-ray and appears white on X-ray films.

Direct visualization of the rectum and the large intestine can be accomplished with flexible viewing tubes known as colonoscopes. This procedure is called colonoscopy and is more accurate than barium X-rays in detecting small ulcers or small areas of inflammation of the colon and terminal ileum.

Colonoscopy also allows for small tissue samples (biopsies) to be taken and sent for examination under the microscope to confirm the diagnosis of Chron’s disease. Colonoscopy also is more accurate than barium X-rays in assessing the degree (activity) of inflammation.

Computerized axial tomography (CAT or CT) scanning is a computerized X-ray technique that allows imaging of the entire abdomen and pelvis. It can be especially helpful in detecting abscesses.

CT and MRI are imaging techniques which provide more adequate luminal distension. These have been reported to be superior in the evaluation of small bowel pathology in patients with Chron’s disease.

Video capsule endoscopy (VCE) has also been added to the list of tests for diagnosing Chron’s disease.

For video capsule endoscopy, a capsule containing a miniature video camera is swallowed. As the capsule travels through the small intestine, it sends video images of the lining of the small intestine to a receiver carried on a belt at the waist.

The images are downloaded and then reviewed on a computer. The value of video capsule endoscopy is that it can identify the early, mild abnormalities of Chron’s disease.

In a prospective blinded evaluation, video capsule endoscopy was demonstrated to be superior in its ability to detect small bowel pathology missed on small bowel radiographic studies and CT exams.

VCE procedure should not be performed in patients who have an obstruction or intestinal strictures of the small intestine. The capsule may become stuck at the site of obstruction and make the obstruction worse.

There is also a theoretical concern for electrical interference between the capsule and implanted cardiac pacemakers and defibrillators.


Treatment of Chron’s Disease

Treatment for Crohn’s disease may involve medication, surgery, and nutritional supplements. The aim is to control inflammation, resolve nutritional problems, relieve symptoms, and reduce the occurrence of flares.  However, there is no medication that can cure Chron’s disease.

The course of treatment will depend on:

  • Where the inflammation occurs
  • The severity of the issue
  • Any complications
  • A patient’s response to previous treatments

 

 

 

  • During remissions, these symptoms improve. Remissions usually occur because of treatment with medications or surgery, but occasionally they occur spontaneously without any treatment.

 

  • Since there is no cure for Chron’s disease, the goals of treatment are to:
    • Induce remissions
    • Maintain remissions 
    • Improve the quality of life
    • Minimize the side effects of treatment, and


Treatment of Chron’s disease and ulcerative colitis with medications is similar though not always identical.

  • Anti-inflammatory agents such as 5-ASA compounds and corticosteroids, topical antibiotics, immunomodulators, and biosimilars are medications used to treat Chron’s disease.

 

  • Selection of treatment regimens depends on disease severity, disease location, and disease-associated complications.

 

  • Various treatment guidelines recommend that approaches be sequential. Initially to induce clinical remission, and then to maintain remissions. Initial evidence of improvement should be seen within 2 to 4 weeks, and maximal improvement should be seen in 12 to 16 weeks. The classic approach to therapy in Chron’s disease has been a “step-up” approach starting with the least toxic agents for mild disease, and increasingly more aggressive treatment for more severe disease, or patients who have not responded to less toxic agents.

 

  • Treatment has been moving toward a “top-down” approach (early aggressive management) which might decrease exposure to anti-inflammatory agents and increase exposure to agents that enhance mucosal healing that might prevent future complications.

Medication

There are many medications to manage the symptoms of Chron’s disease, including the following:

  • Aminosalicylates: These are anti-inflammatory drugs and include balsalazide (Colazal) and mesalamine (Lialda). A doctor may prescribe these for a person with a new diagnosis and mild symptoms.
  • Steroids: These may include oral steroids, such as prednisone  (Rayos) and budesonide (Entocort), or intravenous steroids, such as methylprednisolone (Solu-Medrol). They are for short-term use only, as they can have severe adverse effects.
  • Antibiotics: These can be useful during Crohn’s flare-ups if a person has an abscess or fistula.
  • Antidiarrheal drugs and fluid replacements: When the inflammation subsides, diarrhea usually becomes less severe.However, the patient may still need something to treat diarrhea and abdominal pain. It is important to have the choice of treatment guided by a doctor, because some antidiarrheal drugs can mask an infection that needs treating.

Biologics

These are a type of drug that scientists have developed from living organisms. Biologics reduce the body’s immune response by targeting proteins that lead to inflammation. They appear to help patients with Chron’s disease.

Below are some examples:

  • Anti-tumor necrosis factor agents, such as infliximab (Remicade), adalimumab (Humira), and certolizumab pegol (Cimzia)
  • Integrin receptor antagonists, such as vedolizumab (Entyvio)
  •  Interleukin-23 therapy, ( anti-interleukin-12) which may include ustekinumab (Stelara)
  • anti-Janus kinase 1, such as tofacitinib (Xeljanz)

Examples of biologics for Crohn’s disease include the following:

  • infliximab (Remicade)
  • adalimumab (Humira)
  • certolizumab pegol (Cimzia)

Biologic treatments can have side effects, including vomiting, nausea, and weakened resistance to infection.

Some studies suggest that using biologics can reduce the likelihood of needing abdominal surgery within 10 years to 30%. Before the introduction of biologics, researchers put this figure at 40–55%.

Biologics also appear to reduce the risk of adverse effects of corticosteroids.

There are different types of biologic drugs, and each person reacts to these differently. A doctor will recommend a suitable option and suggest alternatives or combinations of drugs if the first choice proves ineffective.


    Surgery for Chron’s Disease

    There is no surgical cure for Chron’s disease. Even when all of the diseased parts of the intestines are removed, inflammation frequently recurs in previously healthy intestines months to years after the surgery.

    Surgery in Chron’s disease is used primarily for:

    1. Removal of a diseased segment of the small intestine that is causing obstruction.
    2.  Drainage of pus from abdominal and perirectal abscesses.
    3. Treatment of severe anal fistulae that do not respond to drugs.
    4. Resection of internal fistulae (such as a fistula between the colon and bladder) that are causing infections.

    Post Surgery

    • Usually, after the diseased portions of the intestines are removed surgically, patients can be free of disease and symptoms for some time, often years. When successfully performed, surgery can lead to a marked improvement in a patient’s quality of life. In many patients,Crohn’s disease eventually returns, affecting previously healthy intestines.

     

    • The recurrent disease usually is located at or near the site of surgery. In fact, half of patients can expect to have a recurrence of symptoms within four years of surgery. Drugs such as Pentasa or 6-MP have been useful in some patients to reduce the chances of relapse of Crohn’s disease after surgery.

     

    • There is accumulating evidence in favor of post-operative therapy to delay recurrence in Crohn’s disease. There appears to be some benefit of mesalamine in reducing the risk of post-op recurrence for up to 3 years.A study has shown infliximab to be effective in preventing postoperative recurrence after ileocecal resection, though relapse may occur when therapy is stopped.

     

    • Treatment strategies by severity and location of disease (Based on the Second European Evidence-Based Consensus on the Diagnosis and Management of Chron’s disease.

    Natural Treatment for Chron’s Disease

    Since there is no known cure for Chron’s disease. Patients can help manage their symptoms using natural treatments  that are complementary to the prescription medications.

    Some natural approaches to Crohn’s disease symptoms include:

    • Dietary changes: During a flare-up, avoid high fiber foods, dairy products, sugar, high fat foods, and spicy foods. Between flare-ups, drink more water, eat small meals, boil or steam food instead of frying it, and keep a food diary to track the effects of different foods.
    • Behavioral changes: Consider quitting smoking, if this applies. And try relaxation practices and techniques, such as meditation, mindfulness, and yoga. Exercise and mental health counseling could be helpful, as well.
    • Supplements: Certain supplements, including curcumin, probiotics, bromelain and wormwood, may prove effective.
    • Essential oils: Some essential oils, such as patchouli, peppermint, and fish oil may help reduce inflammation. There is not enough scientific evidence to confirm that any of these approaches are safe and effective.However, experts say that quitting smoking can help reduce the severity of symptoms and the frequency of flareups. Patients with Chron’s disease who continue to smoke are more likely to have intestinal strictures and other complications.

     

    Complications of Chron’s Disease

    Chron’s disease causes the following two types of complications:

    Local Complications:

    These only affect the patients intestines

    Systemic Complications:

    These affect the patient’s whole body. These type of complications are also known as  extra intestinal complications.

    Local complications of Chron’s disease include the following:

    • Abscess: This pocket of pus develops because of bacterial infections. It can form on the walls of the intestines and bulge out. Or you might get one near the anus that looks like a boil. The patients will notice swelling, tenderness, pain, and fever.
    • Bile salt diarrhea: Chron’s disease most often affects the ileum, the lower end of the intestine. This part usually absorbs bile acids, which the body makes to help it absorb fat. If the body can’t process the fat, you could get this type of diarrhea.
    • Fissure: This is a painful tear in the lining of the anus. It can cause bleeding during bowel movements.
    • Fistula: Sores or ulcers can turn into openings called fistulas that connect two parts of the intestine. They can also tunnel into nearby tissues, like the bladder, vagina, and skin.
    • Malabsorption and malnutrition. Crohn’s affects your small intestine, the part of your body that absorbs nutrients from food. After you’ve had it for a long time, your body may no longer be able make the most of what you do eat.
    • Small intestinal bacterial overgrowth (SIBO): Your gut is full of bacteria that help you break down food. When this happens higher up in your digestive tract than usual, you can get gas, bloating, abdominal pain and diarrhea.
    • Strictures: These narrowed, thickened areas of your intestines result from the inflammation that comes with Chron’s disease. They can be mild or severe, depending on how much of the intestine is blocked. Symptoms include cramping, abdominal pain, and bloating.

     

    Systemic Complications of Chron’s disease include the following:

    Arthritis: Joint inflammation, which leads to pain, swelling, and a lack of flexibility, is the most common systemic complication.

    Following are the three types of arthritis which develops because of Chron’s disease:

    • Axial: This type of arthritis affects the spine or lower back (the doctor may call it your sacroiliac joint).
    • Ankylosing Spondylitis :This more serious type of spinal arthritis is rare among people with Chron’s disease, but it can happen. It can also lead to inflammation in your eyes, lungs, and heart valves.
    • Peripheral: This type affects large joints in your arms and legs, like your elbows, knees, wrists, and ankles.

     

    Skin problems: These are the second most common systemic complication. Those most often linked to Crohn’s disease include:

    Erythema nodosum: These small, tender, red nodules usually show up on your shins, ankles, and sometimes arms.

    Mouth ulcers: These are also known as canker sores. They form between your gum and lower lip or along the sides and bottom of your tongue.

    Pyoderma gangrenosum. These pus-filled sores often follow an injury or other skin trauma. They often appear on your legs but can show up anywhere.

    Skin tags: These small flaps of skin are common in patients with Chron’s disease, especially around the anus.

     

    Prognosis of Chron’s Disease

    • There is no cure for Chron’s disease, only treatments for pain and other symptoms.
    • Chron’s disease is a chronic inflammatory disease involving predominantly the small intestine and colon. The symptoms and the activity of the disease can come and go. Even though many effective medications are available to control the activity of the disease, there is as yet no cure for Chron’s disease.
    • Surgery can significantly improve the quality of life in selected individuals, but recurrence of the disease after surgery is common.
    • Chron’s disease can have complications, both within and outside of the intestine.
    • Newer treatments are actively being evaluated.
    • A better understanding of the role of genetics and environmental factors in the cause of Chron’s disease may lead to improved treatments and prevention of the disease.

     

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