A Study to Evaluate the Role of Probiotics in Allergic Rhinitis

Abstract

To compare treatment outcomes in allergic rhinitis patients with and without probiotics. The present study was conducted in the Out Patient Department of ENT in a Tertiary Care Hospital w.e.f. April 2023 till March 2024. Total 106 patients of allergic rhinits were included in the study and were divided randomly into 2 groups with 53 in each group. Group A was given probiotics along with standard treatment of antihistaminics and topical steroids and group B was given antihistaminics and topical steroids only. Total Nasal Symptoms Score (TNSS) of all patients was calculated at the time of enrollment and after 8 weeks post treatment. Based on the pre-treatment and post-treatment TNSS, an analysis was made whether probiotics could be an add-on therapy along with the standard treatment given for allergic rhinitis from past so many years. We conducted our study on 106 patients with mean age of 28.1 ± 8.91 years.44% were male and 56% were female. In group A pre-treatment TNSS was 8.057 + 2.307 and post treatment TNSS was 0.887 + 0.776. In group B pre-treatment TNSS was 9.45 + 0.514 and post treatment was 1.89 + 0.776. The mean post-treatment TNSS in group A was lower than the group B. This difference was statistically significant with p value of < 0.05. Based on the study we can suggest that probiotics could be a potential add-on strategy in the management of allergic rhinitis. Probiotic supplement action seems to be effective in ameliorating allergic rhinitis symptoms and improving the quality of life. However further clinical and molecular studies are required to improve our knowledge about interactions among candidate probiotics and host microbiome, cells and immune defenses, in order to create efficacious interventions.

Introduction

Allergic rhinitis (AR) is characterized by a nasal sensitive inflammation, which is estimated to affect 10–40% of the worldwide population. Common symptoms of AR are nasal itching, sneezing, rhinorrhea, and nasal congestion [1]. The “Allergic Rhinitis and its Impact on Asthma” (ARIA) guidelines classify allergic rhinitis (AR) as “intermittent” or “persistent”, depending on the symptom duration. Sometimes, the terms “seasonal” or “perennial” are connected with AR, instead of “intermittent” or “persistent”. The severity of symptoms is classified as “mild” or “moderate/severe” depending on the impact on the quality of living [2].

Allergic diseases are described as an inadequate immune response of T helper (Th2) cell lymphocytes to environmental or food antigens. Activating this response results in the secretion of interleukins (IL-4, IL-5, IL-13) and the production of IgE specifically for allergens. The induction of Th2 cytokine responses also inhibits Th1 activity primarily via interferon, which helps maintain an allergic phenotype. The stability of the Th1/Th2 balance is governed by the expression of the transcription factors GATA-3 (Th2) and T-bet [4].

There is documented data that patients with AR have dysbiosis at the nasal level and in the gut. Therefore, there is convincing evidence that deranged microbiota promotes, amplifies, and maintains the pathophysiologic mechanisms involved in AR. Early antibiotic abuse has been associated with an increased prevalence of allergic disorders [3]. Gut microbiota is one of the most investigated topics in the last couple of years. Human microbiota represent a community of commensal, symbiotic, and pathogenic bacteria that live in and on human body with the widest and probably most important community in human gut. Ilja Iljic Mecnikov was the first scientist who proved benefits of so-called good lactic acid produced bacteria particularly on gastrointestinal tract. In his hypothesis on autointoxication, he claimed that human body is intoxicated with toxins and pathogenic bacteria from food and he proposed the consumption of lactic acid bacteria contained in Bulgarian yogurt in treating this disorder [5].

Etymologically the term probiotic is derived from the Greek language meaning “for life” but the definition of probiotics has evolved over time simultaneously with the increasing interest in the use of viable bacterial supplements and in relation to the progress made in understanding their mechanisms of action. The term was originally used to describe substances produced by one microorganism that stimulated the growth of others and was later used to describe tissue extracts that stimulated microbial growth and animal feed supplements exerting a beneficial effect on animals by contributing to their intestinal flora balance. The definition used at present was given by the Food and Agriculture Organization of the United Nations World Health Organization, according to which probiotics were redefined as “live microorganisms which when administered in adequate amounts confer a health benefit on the host.” In relation to food the definition can be adjusted by emphasizing that the beneficial effect is exerted by the microorganisms “when consumed in adequate amounts as part of food” [8].

Probiotics act by enhancing the Th1 pathway and production of T regulator (Treg) cells, and by inhibiting the Th2 and Th17 pathways. The development of tolerogenic dendritic cells and the stimulation of Toll-like receptors (TLR) -2/-9 are important effects. New findings are being added to the systemic action mechanisms of probiotics every day. It has been shown in a study that it can suppress the production of histamine signaling with lactic acid bacteria [6]. Due to the above findings, the present study was conducted with the aim to evaluate the role of probiotics in allergic rhinitis.

Methodology

The present prospective study was conducted in our tertiary care centre after approval by Institutional Ethics Committee on 106 clinically diagnosed patients of allergic rhinitis w.e.f. April 2023 to March 2024. Informed written consent was taken from all the patients participating in our study.

Inclusion Criteria

• Age 15–60 years of either sex.

• Clinically diagnosed cases of Allergic Rhinitis.

Exclusion Critteria

• Age < 15 years and > 60 years.

• Associated comorbidities like gastric diseases, IBS, liver diseases, renal diseases.

• History of other medications like immunomodulators.

• History of immunotherapy.

• History of probiotic consumption for long duration in the past 1 year.

All 106 patients were asked relevant detailed clinical history and subjected to local examination of ear, nose and throat. The patients were randomly divided into 2 groups:- Group “A” included 53 patients which were treated with probiotics along with oral antihistaminics and topical steroids while Group B included 53 patients who were treated with only oral antihistaminics and topical steroids.

In this study we gave a combination of probiotic species of Lactobacillus sporogenes, Streptococcus faecalis and Clostridium butyricum which comes in market as a single capsule. Patient was advised to take 1 capsule 2 times a day, in morning and evening after the meal.

All patients were subjected to Total Nasal Symptoms Score (TNSS), a scoring scale used for evaluating symptoms of allergic rhinitis as depicted in Table 1 prior to initiation of treatment and 8 weeks post treatment. TNSS was calculated by addition of individual symptoms score of all 5 symptoms including nasal congestion, rhinorrhea, itching, sneezing and anosmia. TNSS was also calculated post-treatment at 8 weeks.

Table 1.

Total nasal symptom score showing 5 symptoms of allergic rhinits including nasal congestion, rhinorrhea, itching, sneezing and anosmia along with the score given to patient on the basis of severity of symptom as mild, moderate and severe as 1, 2, 3 respectively

Symptoms	No symptoms	Mild symptoms	Moderate symptoms	Severe symptoms
Nasal Congestion	0	1	2	3
Rhinorrhea	0	1	2	3
Itching	0	1	2	3
Sneezing	0	1	2	3
Anosmia	0	1	2	3

All the collected data was entered in the proforma and then entered in Microsoft excel spread sheet and data was grouped in tables. Appropriate statistical analytical tests were applied as per the advice of statistician and then inference was made whether use of probiotics led to significant relief from symptoms or not.

Results

A total of 106 clinically diagnosed cases of allergic rhinitis patients including 47 males and 59 females (female to male ratio being 1.2:1) were enrolled in the study. The mean age of the subjects was 28.1 ± 8.91 years with range of 15 to 54 years.

The mean Total Nasal Symptom Score (TNSS) before starting the treatment was found to be 8.057 ± 2.307 and 9.45 ± 1.514, in group A and group B respectively. After 8 weeks of treatment the mean TNSS in group A was 0.887 ± 0.776 and in group B was 1.89 ± 0.776, as depicted in Fig. 1; Table 2.

Fig. 1.

TNSS pre and post treatment in group A and group B

Table 2.

TNSS pre and post treatment in group A and group B

	Pre-treatment TNSS	Post treatment TNSS
Group A	8.057 ± 2.307	0.887 ± 0.776
Group B	9.45 ± 1.514	1.89 ± 0.776

After running student’s t test the mean TNSS post treatment in group A was significantly lower than group B and this difference was statistically significant as p value was < 0.001.

Thus the addition of probiotics in standard treatment of allergic rhinitis significantly relieved the symptoms and hence improved quality of life of allergic rhinits patients.

Discussion

Allergic rhinitis is a disease which is constantly increasing in the world population, with an estimated prevalence of 0.8 to 39.7% worldwide leading to impaired quality of life. A great increase in prevalence of allergic rhinitis in the last decade can be described with the concept of “hygiene hypothesis” according to which the lack of exposure to infectious agents, gut flora and parasites in early childhood can increase the susceptibility of the child to allergic diseases by modulating immune system development. A multi-center allergy study conducted in Germany on allergic diseases showed age related manifestation of allergy. According to it allergy can be best described in “allergic march” concept according to which allergies start in early infancy as an atopic dermatitis or food allergies, followed by the development of respiratory allergies such as allergic rhinits and/or asthma. According to some authors, it develops even in prenatal period [7, 9].

Since allergic diseases are multifactorial, so both environmental as well as genetic factors play their role in pathogenesis and because of different phenotypes and genotypes, despite of having a large number of treatment options, treating allergies still represents a great challenge. Since conventional allergic medications can cause side effects which limit the patients’ quality of life, it is of interest to find other forms of therapy and the search for new treatment alternatives that could improve patients’ quality of life could be represented by probiotics [10, 11, 12].

Prescribing probiotics causes a significant change in intestinal flora and modulating cytokines secretions, including toll like receptors, signalling molecules, genes and IgA resposes.they suppress the Th2 responses and shifts to Th1 and therefore prevent allergies [4, 17].

Only a single probiotic strain was intensively involved in the studies of the treatment of most of allergic rhinitis, such as Lactobaccilus acidophilus, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus faecalis, Clostridium butyricum, Bifidobacterium longum, Lactobacillus gasseri, Bacillus clausii, Escherichia coli Nissle (EcN) 1917. However, recent studies have evaluated the treatment effect by using more than one strain of probiotics [13, 14, 22].

In particular species of lactobacillus, bifidobacterium, streptococcus etc. have shown anti-allergic effects in various mouse and human studies. Administration of lactobacillus species in adequate amount has shown to alter cytokine profiles, such as elevated Th1 and decreased Th2 cytokines, reduced allergy-related immunoglobulins and cell immigration have been found in both humans and murine studies [2, 14, 15].

Most of the studies analysed showed that probiotics promote an improvement in symptom control and quality of life, a better modulation of the immune response and a positive action on the intestinal microflora [23].Moreover no study shows any adverse side-effect of consuming probiotics for long duration, thus making them a safer therapy also.

Generally, probiotic bacteria need to have a set of criteria for inducing their beneficial effects, including: (1) resistance to pH, bile and digestive enzymes; (2) preventing the binding of pathogens and oral antigens to epileptic cells; (3) increasing the probability of biological efficacy in humans; (4) direct effect on toxicity of bacteria, viruses, fungi and parasites; and (5) proper tolerance and their importance in clinical use for their safety [16]. The probiotic effect is commonly accepted with a daily consumption of minimum 10⁶ CFU/ml or gram of probiotics [24]. A dose less than adequate recommended dose can alter the effects of probiotics leading to their inefficiency in providing desirable benefits. Moreover, the effect of probiotics also get affected by intake of antibiotics [18, 19, 20].

Our study supports that the consumption of probiotics in an adequate amount and duration could positively affect allergic rhinitis patients by alleviating allergic symptoms. No negative effects were reported during the study; thus a making them a suitable treatment option in allergic rhinitis patient. Steiner NC et al. [2], Ciprandi G et al. [3], Filipovic et al. [5], Kechagia M et al. [8], Yousefi B et al. [16] and Ozdemir O et al. [21] showed that probiotics can have a beneficial role in treating allergic rhinitis and can improve the quality of life of patients by improving nasal and ocular symptoms. However Nebrini C et al. [24] findings differs from our results and the study could not find any significant improvement in nasal symptoms with lactobacillus bacteria administration during pollen season. Luo C et al. [1] showed that probiotics combined with antihistamines (combination therapy) have no significant relief in allergic rhinitis symptoms.

Despite the improvement in symptoms and the quality of life of patients to prove the role of probiotics in allergic rhinitis, the available data is limited, and more qualified studies with larger sample sizes are needed.

Limitation of Study

Despite the contributions of this study, it also has some limitations that should be considered. The study’s sample size is small and additionally the research was conducted in a specific geographic region, potentially limiting the applicability of the results to other settings with different culture or environmental factors. Moreover, we in our study used a subjective quality of life assessment and no objective parameters were used in study. For more significant results a longer follow-up period may be required so as to know the long term benefits of using probiotics as a part of management in allergic rhinitis.

Conclusion

Currently, the prevention and treatment of allergic diseases is one of the major clinical challenges. The rapid rise in immune related disorders, such as allergic rhinitis, is strongly associated with reduced exposure to early microorganisms. According to epidemiological data, allergic diseases have been increasing in the last decades, despite a great variety of effective treatment options available. Standard treatment of allergies is only symptomatic without the capability to change the natural course of allergic disease. After immunotherapy, only probiotics are there that can modify the natural course of the disease. This study showed that the addition of probiotics in standard treatment of allergic rhinitis significantly relieved the nasal symptoms. This study suggests that probiotics could be a potential add-on strategy in managing patients of allergic rhinitis. To sum up, probiotic supplement seems to be effective in ameliorating allergic rhinitis symptoms and improving the quality of life.

Funding

Nil.

Data Availability

Available with corresponding author upon reasonable request.

Declarations

Ethics Approval and Consent to Participate

The study was conducted after approval by institutional ethics committee of GMC Jammu. Written informed consent was taken from all subjects or their legal guardian in case of age of patient being less than 18 years. No animals were used in the study.

Consent for Publication

Written informed consent to publish patients clinical detail was obtained from all the subjects.

Competing Interest

The authors declare they have no competing interest.