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1.  Intestinal Permeability in Children with Food Allergy on Specific Elimination Diets 
Children with food allergy have been shown to have increased small intestinal permeability (IP) following ingestion of the offending food as well as during elimination diets. We investigated IP in asymptomatic food-allergic children during an elimination diet to identify clinical characteristics associated with altered IP.
Urinary recovery ratios of lactulose and mannitol (L/M) were determined five hours following ingestion of 7.5 g of lactulose and 2 g of mannitol in 131 cow’s milk- and egg-allergic children. An L/M ratio of ≥0.025 was considered abnormal based upon previously established laboratory internal references. A chart review was conducted to assess the clinical characteristics of these patients.
A total of 50 (38%) of the 131 children (median 6.7, range 4.8 – 8.9 years); 66.2% male) with food allergy had elevated IP while asymptomatic on strict elimination diets. Age and height negatively correlated with IP. However, in the regression model analysis, abnormal IP was associated with shorter stature independently of age. Otherwise, food allergic patients with increased IP were comparable in gender, nutritional status, age of onset of food allergy, history of reactions, atopic diseases and family history of food allergies to those with normal IP.
Elevated IP was found in about one-third of asymptomatic food-allergic children on elimination diets and was associated with shorter stature. Our results suggest that increased IP may be an intrinsic trait in a subset of food allergic children. However, large, prospective studies are necessary to determine the role of impaired intestinal barrier in food allergy.
PMCID: PMC3774110  PMID: 23909601
food allergy (hypersensitivity); egg allergy; CM allergy; intestinal permeability; lactulose/mannitol ratio
2.  Developing A Food Allergy Curriculum for Parents 
Food allergy (FA) is potentially severe and requires intensive education to master allergen avoidance and emergency care. There is evidence suggesting the need for a comprehensive curriculum for food allergic families. This paper describes the results of focus groups conducted to guide the development of a curriculum for parents of food allergic children. The focus groups were conducted using standard methodology with experienced parents of food allergic children. Participants were parents (n=36) with experience managing FA recruited from allergy clinics at two academic centers.
Topics identified by parents as key for successful management included as expected: 1) early signs/symptoms, 2) “cross-contamination”, 3) label-reading, 4) self-injectable epinephrine; and 5) becoming a teacher and advocate. Participants also recommended developing a “one pageroad map” to the information, and to provide the information early and be timed according to developmental stages/needs. Suggested first points for curriculum dissemination were emergency rooms, obstetrician and pediatrician offices. Participants also recommended targeting pediatricians, emergency physicians, school personnel, and the community-at-large in educational efforts. Parents often sought FA information from non-medical sources such as the Internet and support groups. These resources were also accessed to find ways to cope with stress. Paradoxically, difficulties gaining access to resources and uncertainty regarding reliability of the information added to the stress experience. Based on reports from experienced parents of food allergic children, newly diagnosed parents could benefit from a comprehensive FA management curriculum. Improving access to clear and concise educational materials would likely reduce stress/anxiety and improve quality of life.
PMCID: PMC3977654  PMID: 21332804
children; food hypersensitivity; qualitative; education; quality of life
3.  Food Allergy Education for School Nurses: A Needs Assessment Survey by the Consortium of Food Allergy Research 
Food allergy is increasing in school-age children. School nurses are a primary health care resource for children with food allergy and must be prepared to manage allergen avoidance and respond in the event of an allergic reaction. An anonymous survey was administered to school nurses attending their association meetings to determine their educational needs regarding children with food allergy. With 199 school nurses responding, their self-reported proficiency for critical areas of food allergy knowledge and management varied, with weaknesses identified particularly for emergency plan development, staff education, delegation, developing guidelines for banning foods and planning school trips. Nurses reported a high interest in obtaining educational materials in these areas and prefer video and Internet resources that could be promoted through professional organizations.
PMCID: PMC3888215  PMID: 20404357
school nurses; food allergy; education; emergency plan
Baked egg is tolerated by a majority of egg-allergic children.
To characterize immunologic changes associated with ingestion of baked egg and evaluate the role that baked egg diets plays in the development of tolerance to regular egg.
Egg-allergic subjects who tolerated baked egg challenge incorporated baked egg into their diet. Immunologic parameters were measured at follow-up visits. A comparison group strictly avoiding egg was used to evaluate the natural history of the development of tolerance.
Of the 79 subjects in the intent-to-treat group followed for a median of 37.8 months, 89% now tolerate baked egg and 53% now tolerate regular egg. Of 23 initial baked egg-reactive subjects, 14 (61%) subsequently tolerated baked egg and 6 (26%) now tolerate regular egg. Within the initially baked egg-reactive group, subjects with persistent reactivity to baked egg had higher median baseline egg white (EW)-specific IgE levels (13.5 kUA/L) than those who subsequently tolerated baked egg (4.4 kUA/L; P=0.04) and regular egg (3.1 kUA/L, P=0.05). In subjects ingesting baked egg, EW-induced SPT wheal diameter and EW-, ovalbumin-, and ovomucoid-specific IgE levels decreased significantly, while ovalbumin- and ovomucoid-specific IgG4 levels increased significantly. Subjects in the per-protocol group were 14.6 times more likely to develop regular egg tolerance than subjects in the comparison group (P < 0.0001), and they developed tolerance earlier (median 50.0 versus 78.7 months; P<0.0001).
Initiation of a baked egg diet accelerates the development of regular egg tolerance compared to strict avoidance. Higher serum EW-specific IgE level is associated with persistent baked and regular egg reactivity, while initial baked egg reactivity is not.
PMCID: PMC3428057  PMID: 22846751
egg allergy; hen’s egg allergy; baked egg; heated egg; food allergy; egg tolerance; oral food challenge; egg allergy immunotherapy
5.  Development and validation of educational materials for food allergy 
The Journal of Pediatrics  2011;160(4):651-656.
To develop and validate a food allergy educational program.
Study design
Materials developed through focus groups, parental and expert review were submitted to 60 parents of newly referred children having a prior food allergy diagnosis and an epinephrine autoinjector. The main outcome was correct demonstration of an autoinjector.
The correct number of autoinjector activation steps increased from 3.4 to 5.95 (of 6) after training (p<.001) and was 5.47 at 1 year (p<.05). The mean score for comfort with using the autoinjector (7 point Likert scale) before the curriculum was 4.63 (somewhat comfortable) and increased to 6.23 after the intervention (p<.05) and remained elevated at 1 year (6.03). Knowledge tests (maximum 15) increased from a mean score of 9.2 to 12.4 (p<.001) at the initial visit and remained at 12.7 at 1 year. The annualized rate of allergic reactions fell from 1.77 (historical) the year prior, to 0.42 (p<.001) after the program. On a 7 point Likert-scale, all satisfaction categories remained above a favorable mean score of 6: straight-forward, organized, interesting, relevant, and recommend to others.
This food allergy educational curriculum for parents, now available online at no cost, showed high levels of satisfaction and efficacy.
PMCID: PMC3307837  PMID: 22082955
food allergy; anaphylaxis; education
6.  Dietary baked-milk accelerates resolution of cow's milk allergy in children 
The majority (∼75%) of cow's milk-allergic children tolerate extensively heated-(baked-) milk products. Long-term effects of inclusion of dietary baked-milk have not been reported.
We report on the outcomes of children who incorporated baked-milk products into their diets.
Children evaluated for tolerance to baked-milk (muffin) underwent sequential food challenges to baked-cheese (pizza) followed by unheated-milk. Immunologic parameters were measured at challenge visits. The comparison group were matched to active subjects (using age, sex, and baseline milk-specific IgE) to evaluate the natural history of tolerance development.
Over a median of 37 months (range 8-75 months), 88 children underwent challenges at varying intervals (range 6-54 months). Among 65 subjects initially tolerant to baked-milk, 39 (60%) now tolerate unheated-milk, 18 (28%) tolerate baked-milk/baked-cheese and 8 (12%) chose to avoid milk strictly. Among the baked-milk-reactive subgroup (n=23), 2 (9%) tolerate unheated-milk, 3 (13%) tolerate baked-milk/baked-cheese, while the majority (78%) avoid milk strictly. Subjects who were initially tolerant to baked-milk were 28 times more likely to become unheated-milk-tolerant compared to baked-milk-reactive subjects (P<.001). Subjects who incorporated dietary baked-milk were 16 times more likely than the comparison group to become unheated-milk-tolerant (P<.001). Median casein IgG4 levels in the baked-milk-tolerant group increased significantly (P<.001); median milk IgE values did not change significantly.
Tolerance of baked-milk is a marker of transient IgE-mediated cow's milk allergy whereas reactivity to baked-milk portends a more persistent phenotype. The addition of baked-milk to the diet of children tolerating such foods appears to accelerate development of unheated-milk tolerance compared to strict avoidance.
Clinical implications
Addition of dietary baked-milk is safe, convenient, and well-accepted by patients. Prescribing baked-milk products to milk-allergic children represents an important shift in the treatment paradigm for milk allergy.
Capsule summary
The majority of cow's milk-allergic children tolerate extensively baked-milk products, which is a marker of transient IgE-mediated cow's milk allergy. Dietary baked-milk appears to accelerate development of unheated-milk tolerance compared to strict avoidance.
PMCID: PMC3151608  PMID: 21601913
cow's milk allergy; milk allergy; tolerance; extensively heated; baked; immunotherapy; immunomodulation
7.  Clinical safety of FAHF-2, and inhibitory effect on basophils from patients with food allergy – extended phase I study 
Food allergy is a common and increasing health concern in westernized countries. No effective treatment is available and accidental ingestion can be life threatening. Food allergy herbal formula-2 (FAHF-2) blocks peanut anaphylaxis in a murine model of peanut-induced anaphylaxis. It was found to be safe, and well tolerated in an acute phase I study of food allergic patients.
To assess the safety of FAHF-2 in an extended phase I clinical trial and determine potential effects on peripheral blood basophils from food allergic patients.
Patients in an open-label study received 3.3 grams (6 tablets) of FAHF-2 three times a day for 6 months. Vital signs, physical examinations, laboratory data, pulmonary function tests and electrocardiographic data were acquired at baseline and at 2 month intervals. During the course of the study, basophil activation and basophil and eosinophil numbers were evaluated using CCR3/ CD63 staining and flow cytometry.
Of eighteen patients enrolled, 14 completed the study. No significant drug-associated differences in laboratory parameters, pulmonary function studies, or electrocardiographic findings before and after treatment were found. There was a significant reduction (p<.010) in basophil CD63 expression in response to ex vivo stimulation at month 6. There was also a trend towards a reduction of eosinophil and basophil numbers after treatment.
FAHF-2 was safe, well-tolerated, and had an inhibitory effects on basophils in an extended phase I clinical study. A controlled phase II study is warranted.
Clinical Implications
FAHF-2 was safe, well-tolerated and inhibited basophils numbers and activation in a 6 month clinical trial for food allergic patients. FAHF-2 may provide a safe immunotherapeutic option for food allergic patients.
Capsule Summary
FAHF-2 was safe and well-tolerated in a six-month phase-I open label clinical trial for food allergy patients. Immunological beneficial effects of FAHF-2 were decreased basophil numbers and inhibition of activation.
PMCID: PMC3229682  PMID: 21794906
Food allergy; FAHF-2; Basophil activation
8.  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 
Food allergy is a common and serious health problem. A new herbal product, called food allergy herbal formula 2 (FAHF-2), has been demonstrated to have a high safety profile and potent long-term efficacy in a murine model of peanut-induced anaphylaxis.
To evaluate the safety and tolerability of FAHF-2 in patients with food allergy.
In this randomized, double-blinded, placebo-controlled, dose escalation, phase 1 trial, patients received 1 of 3 doses of FAHF-2 or placebo: 2.2 g (4 tablets), 3.3 g (6 tablets), or 6.6 g (12 tablets) 3 times a day for 7 days. Four active and 2 placebo patients were treated at each dose level. Vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data were monitored. Immunomodulatory studies were also performed.
Nineteen food allergic participants were included in the study. Two patients (1 in the FAHF-2 group and 1 in the placebo group) reported mild gastrointestinal symptoms. One patient withdrew from the study because of an allergic reaction that was unlikely related to the study medication. No significant differences were found in vital signs, physical examination results, laboratory data, pulmonary function test results, and electrocardiogram data obtained before and after treatment visits. Significantly decreased interleukin (IL) 5 levels were found in the active treatment group after 7 days. In vitro studies of peripheral blood mononuclear cells cultured with FAHF-2 also demonstrated a significant decrease in IL-5 and an increase in culture supernatant interferon γ and IL-10 levels.
FAHF-2 appeared to be safe and well tolerated in patients with food allergy.
PMCID: PMC3026589  PMID: 20642207
9.  Epinephrine Treatment is Infrequent and Biphasic Reactions Are Rare in Food-Induced Reactions During Oral Food Challenges in Children 
Data about epinephrine utilization and biphasic reactions in childhood food-induced anaphylaxis during oral food challenges are scarce.
To determine the prevalence and risk factors of reactions requiring epinephrine and the rate of biphasic reactions during oral food challenges (OFCs) in children.
Reaction details of positive OFCs in children between 1999 and 2007 were collected using a computerized database. Selection of patients for OFCs was generally predicated on ≤50% likelihood of a positive challenge and a low likelihood of a severe reaction based on the clinical history, specific IgE levels, and skin prick tests (SPTs).
A total of 436 of 1273 OFCs resulted in a reaction (34%). Epinephrine was administered in 50 challenges (11% of positive challenges, 3.9% overall); for egg (n=15, 16% of positive OFCs to egg), milk (n=14, 12%), peanut (n=10, 26%), tree nuts (n=4, 33%), soy (n=3, 7%), wheat (n=3, 9%), and fish (n=1, 9%). Reactions requiring epinephrine occurred in older children (median 7.9 vs. 5.8 years, P<0.001), and were more often caused by peanuts (P=0.006) when compared to reactions not treated with epinephrine. There was no difference in the gender, prevalence of asthma, history of anaphylaxis, specific IgE level, SPTs, or amount of food administered. Two doses of epinephrine were required in 3/50 patients (6%) reacting to wheat, cow’s milk, and pistachio. There was one (2%) biphasic reaction. No reaction resulted in life-threatening respiratory or cardiovascular compromise.
Older age and reactions to peanuts were risk factors for anaphylaxis during oral food challenges. Reactions requiring multiple doses of epinephrine and biphasic reactions were infrequent.
PMCID: PMC2798852  PMID: 20004784
food allergy; autoinjector; self-injectable; epinephrine; children; anaphylaxis; oral food challenge; food-induced anaphylaxis; peanut allergy; tree nut allergy; cow’s milk allergy; milk allergy; egg allergy; allergic reaction

Results 1-9 (9)