Therapeutic Effect of Chinese Herbal Medicine on Food Allergy

Food Allergy Clinical Trial

— FAHF-2  

Official title:

Investigation of the Efficacy of the Food Allergy Herbal Formula (FAHF-2TM) in Patients With Food Allergy - Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00602160
• Other study ID #: R01AT001495-01A1
• Secondary ID: R01AT001495-01A1
• Status: Recruiting
• Phase: Phase 2
• First received: January 15, 2008
• Last updated: November 3, 2010
• Start date: December 2007
• Est. completion date: June 2012

Study information

• Verified date: November 2010
• Source: Li, Xiu-Min, M.D.
• Contact: JingJing Mei
• Phone: 212-241-6577
• Email: jingjing.mei[@]mssm.edu
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The increasing prevalence of allergic diseases in westernized countries poses a significant health problem and a tremendous burden on quality of life and healthcare expenditure. Food allergy affects as many as 6% of young children and 3% to 4% of adults. While the majority of children outgrow their allergy to milk, egg, wheat and soy, allergies to peanut, tree nuts, fish and shellfish are often life-long. Currently, there are no treatments that can cure or provide long-term remission from food allergy. Based on our preliminary studies, we hypothesize that our investigational botanical drug, FAHF-2TM, will be a safe and effective herbal therapy for food allergy. We are enrolling those age 12-45 yrs old with allergies to peanut, tree nuts, sesame, fish, and/or shellfish.

Description:

To address our hypothesis, we propose the following aims:

Aim #1: To investigate the efficacy of FAHF-2TM for food allergy (in addition to current food allergen avoidance).

Aim #2: To characterize the immunomodulatory effects of FAHF-2TM on food allergic patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: June 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

Inclusion Criteria:

• Male and female subjects ages 12 through 45 years of age and otherwise in good health as determined by medical history and physical examination

• History of allergy to peanut, tree nut, sesame, fish or shellfish as documented by a positive skin test and/or food allergen-specific IgE level.

• The subject agrees to participate in the study or the subject's parent or legal guardian is willing and able to give written informed consent, and the pediatric subject gives assent for participation in the study.

• Positive double-blind placebo controlled food challenge to peanut, tree nuts, sesame, fish, or shellfish.

• Females of childbearing potential must be inactive sexually or take effective birth control measures, as deemed appropriate by the investigator, for the duration of the study

Exclusion Criteria:

• History of life-threatening anaphylaxis to peanut, tree nut, sesame, fish or shellfish (involving hypotension or requiring mechanical ventilation)

• Allergy to corn

• Acute febrile illness (such as cold, flu, etc.) within one week before administration of study drug

• Any history of systemic disease that in the investigator's opinion would preclude the subject from participating in this study, e.g. autoimmune disease, neoplasms, HIV or hepatitis virus infection

• Allergic gastrointestinal disease (e.g. allergic eosinophilic esophagitis/gastroenteritis

• Abnormal hepatic function (ALT/AST and bilirubin >1.25 x upper limit of normal)

• Abnormal bone marrow function (WBC <4 x 103/mm3; platelets <100 x 103/mm3; hgb <11 g/dl)

• Abnormal renal function (BUN and creatinine >1.25 x upper limit of normal)

• Clinically significant abnormal electrocardiogram

• Current uncontrolled moderate to severe asthma as defined by:

1. FEV1 value <80% predicted or any clinical features of moderate or severe persistent asthma baseline severity (as defined by the 2007 NHLBI Guidelines) and greater than high daily doses of inhaled corticosteroids (as defined for children and adults using dosing tables from the 2007 NHLBI Guidelines).

2. Use of steroid medications in the following manners: history of daily oral steroid dosing for >1 month during the past year, or burst or steroid course in the past 6 months, or >1 burst oral steroid course in the past year.

3. Asthma requiring >1 hospitalization in the past year for asthma or >1 ED visit in the past 6 months for asthma.

• Participation in another experimental therapy study within 30 days of this study

• History of alcohol or drug abuse

• Currently taking antidepressant medication

• Pregnant or lactating female subjects. Females of childbearing potential will need a negative serum pregnancy test at screening to be considered for this study

• Use of omalizumab

• Use of beta blockers, ACE inhibitors, ARB, or calcium channel blockers, or history of ischemic heart disease

• Inability to discontinue use of antihistamines for skin testing or oral food challenges

• Inability to take the tablets

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Food Allergy
• Food Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• FAHF-2 (TM)
We propose to test 10 tablets administered orally three times daily (t.i.d.) for 6 months in the Phase II study. The subjects will be randomized to 1 of 2 groups; FAHF-2 or Placebo group. Both groups will undergo physician supervised Double-blinded placebo controlled food challenges, once during screening before starting treatment and again after 6 months of therapy.

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Mount Sinai School Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Li, Xiu-Min, M.D.	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of FAHF-2		1 year	Yes
Secondary	lab studies		1 year	No