Difensil Immuno Reduces Recurrence and Severity of Tonsillitis in Children: A Randomized Controlled Trial

Overview

Journal Nutrients

Date 2020 Jun 6

PMID 32498216

Citations 7

Authors

Arianna Di Stadio

Antonio Della Volpe

Fiammetta M Korsch

Antonietta De Lucia

Massimo Ralli

Francesco Martines

Giampietro Ricci

Affiliations

Soon will be listed here.

Abstract

Oral supplements (OS) support the immune system in fighting upper airways infection. This study aimed to analyze the effect of Difensil Immuno (DI) on the recurrence of tonsillitis and fever in children. A multicentric randomized clinical trial was conducted. One-hundred and twenty children with chronic tonsillitis were randomly assigned to group A, B or control. Patients in group A were treated with 10 mL of DI for 90 consecutive days, patients in group B underwent treatment with 15 mL of DI for 45 consecutive days. The following data were collected at baseline (T0), T1 and T2: tonsillitis and fever episodes, tonsillar volume, blood test results. One-way ANOVA was used to analyze within and between variances. Patients in group A and B statistically improved their clinical parameters (episode of tonsillitis and fever, tonsillar volume) when compared to control group both at T1 and T2. However, T1 variances were more consistent in group A than in group B. All patients in the study groups improved their clinical outcomes. No statistically significant variances were observed in blood parameters both at T1 and T2. Our results suggest that children treated with DI had fewer episodes of tonsillitis and fever and a reduction in their tonsillar volume.

Citing Articles

A Supplement with Ribes Nigrum, Boswellia Serrata, Bromelain and Vitamin D to Stop Local Inflammation in Chronic Sinusitis: A Case-Control Study.

De Luca P, DAscanio L, Cingolani C, Latini G, Grigaliute E, Di Mauro P J Clin Med. 2023; 12(8).

PMID: 37109265 PMC: 10142908. DOI: 10.3390/jcm12082929.

Vitamin D Deficit as Inducer of Adenotonsillar Hypertrophy in Children with Obstructive Sleep Apnea-A Prospective Case-Control Study.

De Luca P, Stadio A, Marra P, Atturo F, Scarpa A, Cassandro C Children (Basel). 2023; 10(2).

PMID: 36832406 PMC: 9955224. DOI: 10.3390/children10020274.

Antioxidant Effects of Dietary Supplements on Adult COVID-19 Patients: Why Do We Not Also Use Them in Children?.

Notarbartolo V, Montante C, Ferrante G, Giuffre M Antioxidants (Basel). 2022; 11(9).

PMID: 36139712 PMC: 9495518. DOI: 10.3390/antiox11091638.

Use of Nutraceuticals in Elderly to Fight Inflammation and Immuno-Senescence: A Randomized Case-Control Study.

Maselli Del Giudice A, La Mantia I, Barbara F, Ciccarone S, Ragno M, de Robertis V Nutrients. 2022; 14(17).

PMID: 36079732 PMC: 9459752. DOI: 10.3390/nu14173476.

Single-Center-Single-Blinded Clinical Trial to Evaluate the Efficacy of a Nutraceutical Containing Boswellia Serrata, Bromelain, Zinc, Magnesium, Honey, Tyndallized Lactobacillus Acidophilus and Casei to Fight Upper Respiratory Tract Infection and....

Volpe A, De Luca P, De Lucia A, Martines F, Piroli P, DAscanio L Healthcare (Basel). 2022; 10(8).

PMID: 36011184 PMC: 9408187. DOI: 10.3390/healthcare10081526.

References

Chen H, Zhuo Q, Yuan W, Wang J, Wu T . Vitamin A for preventing acute lower respiratory tract infections in children up to seven years of age. Cochrane Database Syst Rev. 2008; (1):CD006090. PMC: 11842301. DOI: 10.1002/14651858.CD006090.pub2. View

Li C, Lin H, Hsueh K, Wu S, Fang S . Oral administration of Lactobacillus salivarius inhibits the allergic airway response in mice. Can J Microbiol. 2010; 56(5):373-9. DOI: 10.1139/w10-024. View

Amazan D, Cordero G, Lopez-Bote C, Lauridsen C, Rey A . Effects of oral micellized natural vitamin E (D-α-tocopherol) v. synthetic vitamin E (DL-α-tocopherol) in feed on α-tocopherol levels, stereoisomer distribution, oxidative stress and the immune response in piglets. Animal. 2014; 8(3):410-9. DOI: 10.1017/S1751731113002401. View

Inturri R, Stivala A, Furneri P, Blandino G . Growth and adhesion to HT-29 cells inhibition of Gram-negatives by Bifidobacterium longum BB536 e Lactobacillus rhamnosus HN001 alone and in combination. Eur Rev Med Pharmacol Sci. 2016; 20(23):4943-4949. View

DAngelo C, Reale M, Costantini E . Microbiota and Probiotics in Health and HIV Infection. Nutrients. 2017; 9(6). PMC: 5490594. DOI: 10.3390/nu9060615. View

Stelter K . Tonsillitis and sore throat in children. GMS Curr Top Otorhinolaryngol Head Neck Surg. 2015; 13:Doc07. PMC: 4273168. DOI: 10.3205/cto000110. View

Sirisinha S . The pleiotropic role of vitamin A in regulating mucosal immunity. Asian Pac J Allergy Immunol. 2015; 33(2):71-89. View

Vandenplas Y, Veereman-Wauters G, De Greef E, Peeters S, Casteels A, Mahler T . Probiotics and prebiotics in prevention and treatment of diseases in infants and children. J Pediatr (Rio J). 2011; 87(4):292-300. DOI: 10.2223/JPED.2103. View

Prado Acosta M, Geoghegan E, Lepenies B, Ruzal S, Kielian M, Martinez M . Surface (S) Layer Proteins of Block Virus Infection via DC-SIGN Interaction. Front Microbiol. 2019; 10:810. PMC: 6477042. DOI: 10.3389/fmicb.2019.00810. View

10.

Shaik-Dasthagirisaheb Y, Varvara G, Murmura G, Saggini A, Caraffa A, Antinolfi P . Role of vitamins D, E and C in immunity and inflammation. J Biol Regul Homeost Agents. 2013; 27(2):291-5. View

11.

Popovych V, Koshel I, Malofiichuk A, Pyletska L, Semeniuk A, Filippova O . A randomized, open-label, multicenter, comparative study of therapeutic efficacy, safety and tolerability of BNO 1030 extract, containing marshmallow root, chamomile flowers, horsetail herb, walnut leaves, yarrow herb, oak bark, dandelion herb in.... Am J Otolaryngol. 2018; 40(2):265-273. DOI: 10.1016/j.amjoto.2018.10.012. View

12.

Della Volpe A, Ricci G, Ralli M, Gambacorta V, De Lucia A, Minni A . The effects of oral supplements with Sambucus nigra, Zinc, Tyndallized Lactobacillus acidophilus (HA122), Arabinogalactans, vitamin D, vitamin E and vitamin C in otitis media with effusion in children: a randomized controlled trial. Eur Rev Med Pharmacol Sci. 2019; 23(14):6360-6370. DOI: 10.26355/eurrev_201907_18460. View

13.

Harvie M . Nutritional supplements and cancer: potential benefits and proven harms. Am Soc Clin Oncol Educ Book. 2014; :e478-86. DOI: 10.14694/EdBook_AM.2014.34.e478. View

14.

McLaughlin L, Clarke L, Khalilidehkordi E, Butzkueven H, Taylor B, Broadley S . Vitamin D for the treatment of multiple sclerosis: a meta-analysis. J Neurol. 2018; 265(12):2893-2905. DOI: 10.1007/s00415-018-9074-6. View

15.

Bergman P, Lindh A, Bjorkhem-Bergman L, Lindh J . Vitamin D and Respiratory Tract Infections: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. PLoS One. 2013; 8(6):e65835. PMC: 3686844. DOI: 10.1371/journal.pone.0065835. View

16.

Muhamed P, Vadstrup S . [Zinc is the most important trace element]. Ugeskr Laeger. 2014; 176(5). View

17.

Elenius V, Palomares O, Waris M, Turunen R, Puhakka T, Ruckert B . The relationship of serum vitamins A, D, E and LL-37 levels with allergic status, tonsillar virus detection and immune response. PLoS One. 2017; 12(2):e0172350. PMC: 5325266. DOI: 10.1371/journal.pone.0172350. View

18.

Siani A, Strazzullo P, Russo L, Guglielmi S, Iacoviello L, Ferrara L . Controlled trial of long term oral potassium supplements in patients with mild hypertension. Br Med J (Clin Res Ed). 1987; 294(6585):1453-6. PMC: 1246609. DOI: 10.1136/bmj.294.6585.1453. View

19.

Konijeti G, Arora P, Boylan M, Song Y, Huang S, Harrell F . Vitamin D Supplementation Modulates T Cell-Mediated Immunity in Humans: Results from a Randomized Control Trial. J Clin Endocrinol Metab. 2015; 101(2):533-8. PMC: 4880125. DOI: 10.1210/jc.2015-3599. View

20.

Ceccarelli G, Statzu M, Santinelli L, Pinacchio C, Bitossi C, Cavallari E . Challenges in the management of HIV infection: update on the role of probiotic supplementation as a possible complementary therapeutic strategy for cART treated people living with HIV/AIDS. Expert Opin Biol Ther. 2019; 19(9):949-965. DOI: 10.1080/14712598.2019.1638907. View