Studies

Asthma

Inclusion

  • 12 to 80 years old.
  • Documented history of physician-diagnosed asthma for one year or more. (Verified by medical records)
  • Using a stable daily ICS/LABA regimen.
  • Willing to undergo multiple pulmonary function tests throughout the study.
  • Willing to change current asthma treatment.
  • Willing to use an effective contraceptive throughout the study.

Exclusion

  • Life threatening asthma defined as significant episodes requiring intubation.
  • Currently on biological therapy for asthma.
  • Other serious respiratory issues such as COPD, bronchiectasis, tuberculosis, etc.
  • History of drug or alcohol abuse.
  • Narrow angle glaucoma or changes in vision.
  • Cancer not in complete remission for at least 5 years.
  • Depot corticosteroid use within the last year.
  • Regular use of a nebulizer for receiving asthma medications.
  • Planning to become pregnant during the course of the study.

Ulcerative Colitis

Inclusion

  • 18 to 80 years old.
  • Diagnosis of ulcerative colitis for at least 3 months.
  • Currently symptomatic defined as increased stool frequency and rectal bleeding.
  • Willing to undergo endoscopy with biopsies.
  • Had an inadequate response or intolerance to conventional treatment, which includes:
    • Oral aminosalicylates (i.e. mesalamine, sulfasalazine…)
    • Oral corticosteroids (i.e. budesonide, prednisone…)
    • Methotrexate
    • 6-mercaptopurine
    • Biologic treatments (i.e. Stelara, Remicade…)

Exclusion

  • Extensive resection of the colon.
  • Chronic use of NSAIDS (ibuprofen, naproxen, etc.) defined as 3 times per week for more than 3 months. (Daily aspirin is permissible.)
  • History of cancer with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Chronic kidney disease.
  • Drug or alcohol abuse.
  • Planning to become pregnant during the course of the study.
Crohn’s Disease

Inclusion

  • > 17 years old.
  • Diagnosis of Crohn’s disease for at least 3 months.
  • Currently symptomatic defined as increased stool frequency and/or abdominal pain.
  • Willing to undergo endoscopy with biopsies.
  • Current treatment with OR an inadequate response or intolerance to conventional treatment, which includes:
    • Oral aminosalicylates (i.e. mesalamine, sulfasalazine…)
    • Oral corticosteroids (i.e. budesonide, prednisone…)
    • Methotrexate
    • 6-mercaptopurine
    • Biologic treatments (i.e. Stelara, Remicade…)

Exclusion

  • Complications of Crohn’s disease, such as strictures/stenosis, short gut syndrome, etc.
  • Draining stoma or ostomy.
  • Cancer within the past 5 years
  • Drug or alcohol abuse.
  • Planning to become pregnant during the course of the study.
Pediatric Constipation

Inclusion

  • 6 months to 17 years old.
  • Must meet Rome IV criteria:
    • ≤2 bowel movements a week and 1 or more of the following for at least a month:
    • ≥1 episode of fecal incontinence per week.
    • History of retentive posturing or excessive volitional stool retention.
    • History of painful or hard bowel movements.
    • Presence of large fecal mass in the rectum.
    • History of large diameter stools which can obstruct the toilet.
  • Willing to stop current treatment such as laxatives or enemas.

Exclusion

  • Diagnosis of irritable bowel syndrome (IBS).
  • Intestinal perforation or obstruction.
  • Significant kidney disease.
  • History of alcohol or drug abuse.
  • Other causes of constipation like endocrine, metabolic, neurologic, or organic disorders.
  • Celiac disease.
  • Cow milk allergy.
  • Lactose intolerance.
  • Planning to become pregnant during the study.
Pediatric Migraine

Inclusion

  • 6 to 17 years old.
  • History of migraine for at least 6 months
  • Migraines lasting between 3 – 72 hours if untreated or treated successfully and migraine episodes are separated by at least 48 hours of headache pain freedom.
  • History of 1 to 14 migraine attacks per month with moderate to severe headache for at least 2 months.
  • Current or past use of at least 1 oral medication for the acute treatment of migraine.
  • Weigh between 44 and 298 pounds.
  • Able to swallow pills.

Exclusion

  • Cancer within the past 5 years.
  • Difficulty distinguishing between migraine headache and tension-type or other headaches.
  • Planning to become pregnant during the study.
Eosinophilic Esophagitis

Inclusion

  • 18 to 65 years old.
  • Willing to undergo endoscopy with biopsies.
  • Willing to have pulmonary function and vision tests at screening.
  • Have an eosinophilic esophagitis diagnosis prior to screening.
  • Have dysphagia, defined as solid food going down slowly or getting stuck in the throat with an average frequency of ≥2 episodes per week over 2 weeks

Exclusion

  • Any other conditions that may be contributing to dysphagia, eosinophilia, or may interfere with the evaluation of the esophagus.
  • Oral immunotherapy or sublingual immunotherapy within the past year.
  • Organ transplant (except corneal).
  • Immunodeficiency syndromes or history of opportunistic infection.
  • HIV, hepatitis B, or hepatitis C.
  • Cancer within the past 5 years.