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Food AllergyPhase 2FAHF-2NCT00602160

Therapeutic Effect of Chinese Herbal Medicine on Food Allergy

A Phase 2 study testing FAHF-2 (TM) in people with Food Allergy, run by Li, Xiu-Min, M.D. at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Food Allergy
What is being tested?
FAHF-2 (TM)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
2 sitesUnited States
Study dates
Dec 2007to Jun 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 21Show fewer
  • 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:
  • 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).
  • 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.
  • 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

Trial locations and contacts

2 sites in 1 country.

JingJing Mei contact

212-241-6577

jingjing.mei@mssm.edu

Sharon M Hamlin contact

212-241-1755

sharon.hamlin@mssm.edu

United States2 sites, 2 recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas

    June Staw, JAStraw@uams.edu

    Christie Lynn, ChristieLynn@uams.edu

    Recruiting

  • Mount Sinai School Medicine

    New York, New York, 10029

    Julie Wang, M.D.

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed 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

Conditions
Food Allergy
Being tested
FAHF-2 (TM)
Keywords
Food allergy, Chinese Herbs, Investigational new drug, Herbs, Therapeutic medicine, Traditional Chinese medicine
Medical subject headings
Food Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FAHF-2 (TM)Drug

    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.

Study groups in NCT00602160
Study groupRoleWhat they receive
1Active comparator2 different dosages
Receives: Drug: FAHF-2 (TM)
2Placebo comparatorNot described
Receives: Drug: FAHF-2 (TM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety of FAHF-2

    Measured: 1 year

Secondary outcomes (1)

  1. lab studies

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2008 (estimated)
  2. Study startDec 2007
  3. Primary completionMay 2012 (estimated)
  4. Study completionJun 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00602160
Sponsor's protocol ID
R01AT001495-01A1
Other IDs
R01AT001495-01A1
Acronym
FAHF-2
Status last verified
Nov 2010
First submitted
15 Jan 2008
Last updated
4 Nov 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang Z, Wang ZZ, Geliebter J, Tiwari R, Li XM. Traditional Chinese medicine for food allergy and eczema. Ann Allergy Asthma Immunol. 2021 Jun;126(6):639-654. doi: 10.1016/j.anai.2020.12.002. Epub 2020 Dec 10.

    PubMed 33310179

  • Wang J, Jones SM, Pongracic JA, Song Y, Yang N, Sicherer SH, Makhija MM, Robison RG, Moshier E, Godbold J, Sampson HA, Li XM. Safety, clinical, and immunologic efficacy of a Chinese herbal medicine (Food Allergy Herbal Formula-2) for food allergy. J Allergy Clin Immunol. 2015 Oct;136(4):962-970.e1. doi: 10.1016/j.jaci.2015.04.029. Epub 2015 Jun 1.

    PubMed 26044855

  • Song Y, Wang J, Leung N, Wang LX, Lisann L, Sicherer SH, Scurlock AM, Pesek R, Perry TT, Jones SM, Li XM. Correlations between basophil activation, allergen-specific IgE with outcome and severity of oral food challenges. Ann Allergy Asthma Immunol. 2015 Apr;114(4):319-26. doi: 10.1016/j.anai.2015.01.006.

    PubMed 25841330

  • Noone S, Ross J, Sampson HA, Wang J. Epinephrine use in positive oral food challenges performed as a screening test for food allergy therapy trials. J Allergy Clin Immunol Pract. 2015 May-Jun;3(3):424-8. doi: 10.1016/j.jaip.2014.10.008. Epub 2015 Jan 13.

    PubMed 25609353

  • Yang N, Wang J, Liu C, Song Y, Zhang S, Zi J, Zhan J, Masilamani M, Cox A, Nowak-Wegrzyn A, Sampson H, Li XM. Berberine and limonin suppress IgE production by human B cells and peripheral blood mononuclear cells from food-allergic patients. Ann Allergy Asthma Immunol. 2014 Nov;113(5):556-564.e4. doi: 10.1016/j.anai.2014.07.021. Epub 2014 Aug 22.

    PubMed 25155085

  • Patil SP, Wang J, Song Y, Noone S, Yang N, Wallenstein S, Sampson HA, Li XM. Clinical safety of Food Allergy Herbal Formula-2 (FAHF-2) and inhibitory effect on basophils from patients with food allergy: Extended phase I study. J Allergy Clin Immunol. 2011 Dec;128(6):1259-1265.e2. doi: 10.1016/j.jaci.2011.06.015. Epub 2011 Jul 26.

    PubMed 21794906

  • Wang J, Patil SP, Yang N, Ko J, Lee J, Noone S, Sampson HA, Li XM. Safety, tolerability, and immunologic effects of a food allergy herbal formula in food allergic individuals: a randomized, double-blinded, placebo-controlled, dose escalation, phase 1 study. Ann Allergy Asthma Immunol. 2010 Jul;105(1):75-84. doi: 10.1016/j.anai.2010.05.005.

    PubMed 20642207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing FAHF-2 (TM) in people with Food Allergy, run by Li, Xiu-Min, M.D. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JingJing Mei (212-241-6577, jingjing.mei@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety of FAHF-2 (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00602160, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2010.

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