Putera AM, Irwanto I. Effect of oral food challenge on quality of life and family activities in children with IgE-mediated food allergies. World J Clin Pediatr 2025; 14(3): 106763 [DOI: 10.5409/wjcp.v14.i3.106763]
Corresponding Author of This Article
Azwin Mengindra Putera, PhD, Associate Professor, Department of Child Health, Faculty of Medicine, Universitas Airlangga, Jl. Mayjend Prof. Dr. Moestopo No. 47, Pacar Kembang, Tambaksari, Surabaya 60132, Jawa Timur, Indonesia. azwin-m-p@fk.unair.ac.id
Research Domain of This Article
Allergy
Article-Type of This Article
Observational Study
Open-Access Policy of This Article
This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Azwin Mengindra Putera, Irwanto Irwanto, Department of Child Health, Faculty of Medicine, Universitas Airlangga, Surabaya 60132, Jawa Timur, Indonesia
Azwin Mengindra Putera, Division of Allergy Immunology and Rheumatology, Department of Child Health, Dr. Soetomo General Academic Hospital, Surabaya 60286, Jawa Timur, Indonesia
Irwanto Irwanto, Division of Growth and Development, Department of Child Health, Dr. Soetomo General Academic Hospital, Surabaya 60286, Jawa Timur, Indonesia
Author contributions: Putera AM, Irwanto contributed to conceptualization and design; Putera AM contributed to material preparation, data acquisition, and analysis; all author authors contributed to writing-draft manuscript and writing-revision and approved to submit the final version.
Institutional review board statement: The study was protocol approved by the ethical committee team at Dr. Soetomo General Academic Hospital, Surabaya, Indonesia (No. 0581/LOE/301.4.2/IX/2021).
Informed consent statement: Informed consent was obtained from all participants involved in the study.
Conflict-of-interest statement: All authors declare that they have no conflict of interest.
STROBE statement: The authors read the STROBE Statement checklist of items, and the manuscript was prepared and revised according to it.
Data sharing statement: The datasets generated during and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Azwin Mengindra Putera, PhD, Associate Professor, Department of Child Health, Faculty of Medicine, Universitas Airlangga, Jl. Mayjend Prof. Dr. Moestopo No. 47, Pacar Kembang, Tambaksari, Surabaya 60132, Jawa Timur, Indonesia. azwin-m-p@fk.unair.ac.id
Received: March 7, 2025 Revised: April 14, 2025 Accepted: May 21, 2025 Published online: September 9, 2025 Processing time: 102 Days and 4.5 Hours
Abstract
BACKGROUND
Oral food challenge (OFC) is an integral part of confirming and evaluating the diagnosis of food allergy (FA), and most incidents of FA occur in children. FA significantly impairs the quality of life (QoL) and causes limited activities outside the home for children and their parents.
AIM
To evaluate the effect of OFC on QoL and family activities in children with FA.
METHODS
This prospective study identified children suspected of FA using a skin prick test (SPT) between January 2022 and December 2024. These children conduct an elimination diet for 4 wk, followed by OFC under protocol. Rating scales evaluated QoL using pediatric QoL inventory and family activities using family activities impact scale (FAIS), in which data are collected before and after an elimination diet and OFC. Statistical analysis utilized χ2, Spearman , paired t, Wilcoxon, independent t, and Mann–Whitney tests, with P < 0.05 considered significant.
RESULTS
Most participants were boys (137; 65.55%); 102 (64.56%) had a positive OFC and 35 (68.63%) a negative OFC. The average QoL before OFC was 69.13 ± 5.78, and 92.40 ± 4.22 after OFC (Z = 12.537; P < 0.001). In the FAIS score, the average result before OFC was 5.36 ± 0.68 and 4.10 ± 0.38 after OFC, which was a significant difference (Z = 12.162; P < 0.001). Although the difference in QoL before and after increased, and FAIS reduced, there was no significant difference. Additionally, most results of positive SPT are higher than positive OFC in each specific food allergen.
CONCLUSION
OFC may improve QoL and FAIS in children with FA and their families as it increases activities outside the home and reduces worry about allergen exposure.
Core Tip: Oral food challenge (OFC) is the gold standard for diagnosing food allergy (FA), and diagnosis of FA can affect quality of life (QoL) and family activities. Therefore, OFC can contribute to QoL, including definitive diagnosis, identifying disease severity, reducing anxiety, expanding the diet, increasing activities outside the home, and creating an adaptive environment in which the contributions are also associated with family activities. The crucial suggestion from the study are to create a safe environment for children with FA, in which the teacher and caretaker must improve their knowledge of FA, including its clinical manifestation, anaphylaxis, and administration of adrenaline auto-injection when needed immediately.
Citation: Putera AM, Irwanto I. Effect of oral food challenge on quality of life and family activities in children with IgE-mediated food allergies. World J Clin Pediatr 2025; 14(3): 106763
Food allergy (FA) is an allergic reaction triggered by ingesting food proteins[1]. This allergic reaction may begin with mild symptoms, typically itching, stomach pain, and rash, and progress to severe anaphylaxis[2]. The most common foods that caused allergic reactions included cow's milk, eggs, peanuts, tree nuts, soy, wheat, fish, and shellfish[3]. FA is a public health burden that affects personal, social, nutritional, and economic aspects[4]. FA has commonly occurred in children, with annual incidents increased by 4%–8%[5]. According to a previous study, FA incidents were reported in ~5% of children globally[6] and in 3.4%–11.1% of Asian children[7]. FA cases in Indonesian children were estimated to account for 3%–60% of all allergies[5], and according to a recent study, these cases have been increasing annually[8-10].
Diagnosis of FA is not simple. Despite the clinical history and allergen-specific IgE playing a crucial role in establishing the diagnosis, oral food challenge (OFC) is currently the gold standard for diagnosis of FA[11]. OFC might also be evaluated for the development of tolerance[12]. An identification of OFC was performed, including confirming or refusing allergy, assessing the FA clinically, facilitating the introduction of food-caused allergies, and establishing a threshold dose for clinical reactivity, which may contribute to determining optimal management strategies[13]. Therefore, children with FA with food re-introduction after passing OFC (negative OFC) might ideally reduce anxiety in multiple individuals (such as patients, parents, caregivers, or other families)[14]. Meanwhile, this anxiety has a negative effect on the quality of life (QoL) of children with FA and their families[15].
QoL in children with FA was impacted by anxiety, stress, bullying, and social isolation. Many children with FA and their caregivers have reported impaired psychosocial functioning, which decreased QoL and increased anxiety, worry, and depression. Worry-related accidental exposure, potential reactions, and the burden of allergen avoidance may lead to increased anxiety. The day-to-day challenge for caregivers living with children with FA causes significant stress[16]. Meanwhile, bullying-related FA in children was reported relatively elevated, with estimated incidence of 23%-32%[17]. Therefore, children with FA and their families usually have limited activities and participation in events to avoid allergen exposure, which might cause feelings of isolation for the child and feelings of guilt for the parents[5,16]. Additionally, most family activities for children with FAs revealed social isolation, therefore requiring a gradual evaluation of family activities to improve FA management skills[18].
Family activities in children with FA can be assessed using the Food Allergy Impact Scale (FAIS) [5]. A previous study revealed that FAIS may have multiple effects on daily activities, including elevated stress and reduced participation in non-food-related events[19]. FA reactions can be classified into three groups: IgE-mediated, non-IgE-mediated, and mixed[20]. The type of allergic reaction is IgE-mediated, 5%-10%[2], especially in Indonesia[21]. Therefore, this study investigated the effect of OFC on QoL and family activities in children with IgE-mediated FA.
MATERIALS AND METHODS
Study design
This prospective study used total sampling to identify participants. The data were collected according to the potential participants' eligibility for the study, which began in January 2022 and continued until December 2024. The study participants included 209 children with FA (Figure 1). This study was conducted at a tertiary referral hospital. Informed consent was obtained in writing from the participants under a protocol approved by the hospital's health research ethics committee.
Figure 1 Participants were recruited and identified according to the study's eligibility criteria.
OFC: Oral food challenge.
Participants
The inclusion criteria included children aged 2–18 years; positive IgE-mediated FA determined by skin prick test (SPT); a history of food reaction as verified by medical record review; and approval to conduct an elimination diet. Meanwhile, children with premature birth, thyroid disease, chronic diseases (such as heart or lung diseases), developmental disorders, and a history of anaphylaxis were excluded from the study.
Intervention
A SPT was conducted to determine the potential participants based on a clinical history of FA. Food allergen extracts were chicken meat, chocolate, cow's milk, egg white, egg yolk, freshwater fish, oranges, peanuts, sea fish, shrimps, and tomatoes. The SPT procedure was conducted on the volar surface of the forearm by percutaneous testing application (such as puncture testing) with a drop of food allergen. The reaction should be observed within 15–20 min[22]. The SPT resulted in true-positive reactions when wheal-and-flare diameters were ≥ 3 mm, faded slowly, and participants typically reported pruritic sensations in the skin[11,23]. Additionally, SPT was performed and determined by an allergy-immunology consultant pediatrician.
The elimination diet was a dietary approach to remove potential foods that may cause adverse reactions and replace them with foods that contain similar nutrients. The caregiver was advised to stop giving food that caused allergies to children and to change their dietary intake to one with similar nutrients. The initial elimination diet began immediately after the SPT result was obtained and was performed for 4 wk. The elimination diet outcomes were a success when signs and symptoms of FA did not appear for < 4 wk. Caregivers were educated and collaborated with a nutritionist to create personalized dietary care plans for children with FA, and they also received a book guide on FA diets to facilitate their understanding[24].
The OFC was an examination to investigate the presence or absence of induced symptoms following the intake of specific foods that cause FA with single or multiple doses. OFC was performed using the medium dose method with a gradually increased dose at 15–30 min to be a full dose for each food allergen type based on the Japanese guidelines for FA. In establishing the diagnosis of FA, OFC resulted in a positive diagnosis when adverse reactions appeared after the intake of food allergens. However, there were no adverse effects after 2 h of intake of the full dose of OFC, which was a negative OFC. In practice, OFCs were performed by an allergy–immunology consultant pediatrician, who was required to have available emergency drugs, typically adrenaline, steroids, antihistamines, and bronchodilators for anaphylaxis[24].
Intervention procedures were conducted according to protocol, including SPT, a 4-wk elimination diet, and OFC. Monitoring QoL and FAIS were measured before and after the intervention.
Measurement
The QoL in children with FA might be assessed using the pediatric quality of life inventory (PedsQL), which is usually used to evaluate health-related quality of life in children with general or specific diseases. PedsQL for general disease is most commonly used to evaluate QoL in patients with FA[25]. PedsQL is a 23-item questionnaire divided into five subscales: Physical functions (8 items), emotional functions (5 items), social functions (5 items), and school functions (5 items). Additionally, each item has a range score of 0–4 based on the Likert scale, and the score distribution was presented as 0 for never, 1 for almost never, 2 for sometimes, 3 for often, and 4 for almost always. The PedsQL for general disease Indonesia version was a valid and reliable questionnaire according to a previous study, which this questionnaire has Cronbach alpha of ≥ 0.70[26].
The FAIS measured caregiver perception of the impact of FA in children on daily family activities. This tool was a 32-item questionnaire with eight subscales: Meal preparation; family social activities; caregiver-supervised child social activities; autonomous child social activities; school activities; family relations; caregiver stress and free time; and employment and finances[19]. The FAIS Indonesia version was a valid and reliable questionnaire with a Cronbach’s alpha coefficient of ≥ 0.70[5].
Statistical analysis
The data were analyzed utilizing SPSS version 23.0 (IBM Corp., Armonk, NY, United States). The choice of statistical analysis was conducted based on data distribution with the Kolmogorov–Smirnov test. An independent t-test or Mann–Whitney test was used to compare the effect of OFC on QoL and FAIS. The impact of OFC was evaluated with a paired t-test or Wilcoxon test before and after the intervention. We used the Spearman test to analyze the correlation of FAIS with QoL. We investigated the association between SPT and OFC for each causative food allergen using the χ2 test. P < 0.05 was considered significant.
RESULTS
Characteristics of participants
Most participants were boys (65.55%), with 64.56% OFC positive and 68.63% negative. There was no significant association between sex and OFC (P = 0.595). The average age of participants was 85.20 ± 42.43 mo, with a median age of 76 (54–116) mo. The average age of participants with positive OFC was 86.59 ± 42.97 mo, and 80.04 ± 40.87 mo for negative OFC (Z = 4.722; P < 0.001). Rhinitis (60.29%) was the most common allergic reaction, followed by eczema (41.15%). Pparticipants had an atopic history from their mother (49.28%) and father (39.23%) (Table 1).
Effect of oral food challenges on QoL in children with FA
There was a significant effect on QoL before and after OFC (Z = 12.537; P < 0.001), in which each QoL subscale showed a significant increase in value after OFC than before (Table 2). QoL values before and after OFC showed no significant differences between participants with positive and negative OFC. Although most subscales showed no significant difference after OFC, there was a significant difference between participants with positive and negative OFC in the social subscale (90.41 ± 8.14 vs 93.63 ± 7.62; Z = 2.478; P = 0.013). The social subscale also had a significant difference between participants with positive and negative OFC before and after OFC (30.28 ± 13.87 vs 36.37 ± 12.45; Z = 2.768; P = 0.006). However, other QoL subscales showed no significant differences when compared before and after OFC.
Table 2 Analysis of quality of life and family activities on pre/post-test oral food challenge performance.
Effect of oral food challenges on family activities in children with FA
FAIS in participants was 5.36 ± 0.68 before OFC and reduced to 4.10 ± 0.38 after OFC (Z = 12.162; P < 0.001), with most FAIS subscales also reduced. However, several FAIS subscales showed no significant difference before and after OFC, including family relationships and structure activities/schools (P = 0.816 and P = 0.912, respectively). Before OFC, most FAIS subscales showed no significant difference between positive and negative results. However, work and finance FAIS subscales showed a significant difference between positive and negative OFC before and after OFC. The work and finance FAIS subscales were 5.21 ± 1.38 (positive) versus 5.67 ± 0.92 (negative) before OFC (Z = 2.010; P = 0.44) and 2.58 ± 1.08 (positive) versus 3.04 ± 1.14 (negative) after OFC (Z = 2.601; P = 0.009). Another FAIS subscale with a significant difference after OFC was meal preparation, in which the positive value was 3.18 ± 0.95 and the negative value was 2.81 ± 1.04 (Z = 2.160; P = 0.031). Meal preparation also showed a significant difference between participants with positive (3.02 ± 1.24) and negative (3.84 ± 1.25) OFC before and after OFC (t = 2.334, 95% confidence interval = 0.072–0.861, and P = 0.021) (Table 3). Besides this, there are no significant differences in FAIZ defferenciation values before and after OFC.
Table 3 Analysis of the comparison of differences in value before and after oral food challenge of quality of life and family activities.
Correlation of family activities on QoL in children with FA
An analysis of the association between family activities and QoL showed no significant correlation between the difference in values before and after OFC. The FAIS overall had no correlation with overall QoL, whereas several subscales in both had significant correlations, typically supervised caretaker with QoL total (r = 0.178; P = 0.010), FAIS total with school (r = 0.140; P = 0.042), supervised caretaker with school (r = 0.196; P = 0.005), and child social with school (r = 0.138; P = 0.046) (Table 4).
Table 4 Analysis of the association between differences in values before and after oral food challenge of quality of life and family activities in children with food allergy.
Association between SPT and OFC in children with FA
Most results regarding food types showed a significant association between SPT and OFC (Table 5). However, several food types had no significant associations between SPT and OFC, including freshwater fish (P = 0.289), sea fish (P = 803), and shrimps (P = 0.131).
Table 5 Analysis of the association between skin prick test and oral food challenge in the diagnosis of food allergy, n (%).
OFC, the gold standard for diagnosis of FA, involves administration of food allergens, gradually increasing from the initial low dose to the full dose appropriate for age, under medical supervision[24,27]. The majority of previous studies showed that OFC is associated with significantly improved QoL in children with FA and their parents[4,14,28,29]. The benefits offered by OFC are confirmation of the diagnosis, decreasing uncertainty, and expanding the diet[29]. In another study, OFC was beneficial in classifying the severity of FA and reducing anxiety, as both children with FA and their parents learned how to handle adverse reactions directly in practice[28]. A previous study showed that all parents or caregivers of children with FA were willing to repeat OFC when necessary, and 98% of the cases reported increased QoL after OFC[30]. In our study, the OFC significantly improved QoL.
In the study, negative OFC in children with FA can increase QoL. OFC had a significant effect on family activities in children with FA. Participants with negative OFC were suggested to increase their intake of food allergens to a threshold dose. This might promote the outgrowing of the allergy, which improves QoL. Therefore, negative OFC can be associated with better QoL[31]. Several studies reported that negative OFCs can lead to a higher rate of successfully reintroducing suspected food allergens at home (68%-100%)[32,33]. Children with negative OFC might increase outgrowing FA with regular reintroduction of food allergens accompanied by monitoring and support from family, which is key to success[34,35]. Additionally, children with FA-related limited social interaction or participation due to potential exposure to food allergen when participating in social events[15]. Bullying might occur when participating in events, parties, camps, or school[36]. A previous study showed that children with FA were uncertain about predictable allergen exposure outside the home and should exercise caution when eating out. Therefore, social isolation may increase the incidence of FA[35,37].
The study showed a significant effect of OFC on meal preparation. Negative OFC might result in improvement of nutritional intake and expansion of diet in children with FA[38]. In caregivers, negative OFC also reduces the challenging burden of meal preparation for nutrient intake in children with FA. The challenge of meal preparation is avoidance of food allergens, whereas dietary intake with similar nutrients must be fulfilled for the child's development[5]. Caregivers must learn to prepare food and discuss or consult with nutritionists about eligible food, which is an additional burden for caregivers[24,38]. The OFC may also affect the work environment of caregivers, in which they have reduced their work hours, accepted jobs with fewer responsibilities, and are absent from work to take their child to the emergency room due to an adverse reaction[39]. This condition is considered a caregiver burden, in which FA contributes excess direct and indirect costs. In contrast, they must reduce working activities to accompany the child to repetitive medical consultations, which disturbs their financial situation[40]. This is similar to the present study, which found that OFC significantly impacted work and financial issues in children with FA.
The present study found a significant association between FAIS and QoL in children with FA, especially supervised caretakers with overall QoL, FAIS total with school, supervised caretakers and school, and child social with school. According to a previous study, supervised caretakers have played a crucial role in managing FA, typically in childcare and school settings. This environment is a crucial contributor to adverse reactions, such as food allergen exposure and bullying. Therefore, it is imperative and recommended that the staff of schools or childcare facilities be provided with information related to food-induced reactions, including clinical symptoms of FA, anaphylaxis, and administration of adrenaline autoinjections. The staff should also regularly participate in FA training, thus impacting their confidence and ability to deliver first aid when needed[41]. Parents must be guarded against inadvertently creating an environment of fear that causes over-protecting against FA. Parents must rely on third parties, generally teachers or other parents, for adaptive environments to keep their children safe from food allergen exposure[42].
In the present study, most types of food that cause allergies have a significant association between SPT and OFC. According to a previous study, SPT has a high sensitivity that may support the diagnosis of FA and reduce the number of OFCs. It also has a sensitivity ≥ 90%, contributing to improved diagnostic accuracy. The advantages of SPT were rapid results, high sensitivity, high negative predictive value, and being a predictive factor for OFC. SPT had no overall value in diagnosing FA, which is insufficient to conclude an FA diagnosis[11,43]. Several other studies reported that SPT had false-positive results in 50%–60% of cases[44,45]. This is similar to the study in which the number of positive SPTs was higher than the number of positive OFCs.
Our study had a few limitations. First, the number of participants was small, and the statistical power to identify prognostic factors must be improved. Second, the study lacked healthy controls or participant variability groups. Finally, as perceptions change over time, a longitudinal approach should be considered to elucidate further the effects of managing a child with FA on parental QoL and family activities.
CONCLUSION
OFC can improve QoL. OFC contributes to definitive diagnosis, identifying disease severity, reducing anxiety, expanding the diet, increasing activities outside the home, and creating an adaptive environment. Likewise, family activities can also be influenced by OFC to create an adaptive environment. Besides the home, another environment for children's activities is school. Therefore, third parties, especially other parents or teachers, must support the child's safety. They must follow the regular training in FA management for children, including information on symptoms of FA, anaphylaxis, and administration of adrenalin autoinjections when needed for first aid delivery.
ACKNOWLEDGMENTS
We would like to thank Fis Citra Ariyanto as an English translator and supporting assistant for statistical analysis.
Footnotes
Provenance and peer review: Invited article; Externally peer reviewed.
Peer-review model: Single blind
Specialty type: Allergy
Country of origin: Indonesia
Peer-review report’s classification
Scientific Quality: Grade D
Novelty: Grade B
Creativity or Innovation: Grade D
Scientific Significance: Grade C
P-Reviewer: Missous G S-Editor: Liu JH L-Editor: Kerr C P-Editor: Zhang L
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