Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics.

NCT02113072 | Completed Phase 3 DMC

• 1 other identifier: GAraujo
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent wheezing in infants, stimulating the immune system to Th1 response.

Conditions

Respiratory Tract Diseases; Wheezing

Keywords

wheezing, immune system, cytokines, probiotics, infants.

Outcome Measures

Primary Outcomes (1)

• Recurrent wheezing and cytokine assay.

  After eight weeks of using probiotics, infants will undergo new measurement of cytokines IL-10, IL-12 and INF-γ, with the objective to evaluate the immune response of probiotics in both groups. Before and at the end of each period, the patient will undergo physical examination and parents or guardians to an interview, to assess the occurrence of wheezing attacks. These data will be analyzed to assess whether supplementation with probiotics reduces the frequency of wheezing in infants.

  After 2 months of using probiotic, will be assessed the recurrence of wheezing and cytokine assay.

Study Arms (2)

Probiotics & Beclomethasone

EXPERIMENTAL

It will be supplied in lyophilized form, in each sachet containing 1 g of the probiotic, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days. Beclomethasone HFA 50mcg spray - 100 mcg/day as initial treatment for primary and wheezing in this age group, at doses considered minimal, for 4 months.

Drug: Beclomethasone; Drug: Probiotics

Beclomethasone & Placebo

ACTIVE COMPARATOR

The placebo will be supplied in the same way with the same organoleptic characteristics of formula with probiotics. It will be supplied in lyophilized form in each sachet containing 1 g of placebo, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days.

Drug: Beclomethasone; Drug: Placebo

Interventions

Beclomethasone DRUG

The wheezing infants will be using the inhaled corticosteroid beclomethasone 50mcg - 02 jets per day (100mcg/dia).

Also known as: Clenil

Beclomethasone & Placebo; Probiotics & Beclomethasone

Probiotics DRUG

Lyophilized form, each sachet containing 1 g of the probiotic, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days.

Also known as: Lactobacillus, Bifidobacterium, Leveduras, Acetobacter

Probiotics & Beclomethasone

Placebo DRUG

The placebo will be supplied in the same way with the same organoleptic characteristics of formula with probiotics, 1 g sachet for 60 days, in the juice, milk or yoghurt.

Also known as: Maltodextrose

Beclomethasone & Placebo

Eligibility Criteria

• Age: 6 Months - 23 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged six months to two years incomplete.
• Infants who have recurrent wheezing in the past 3 months.
• Infants under use of proper technique of inhaled corticosteroids: beclomethasone HFA spray - 50 mg - 2 times daily (100 mg / day) with spacer and face mask.

You may not qualify if:

• Patients who present congenital airway malformations, cystic fibrosis, chronic diseases in other systems, perinatal respiratory problems, allergy to the protein in cow's milk, intrathoracic tumors, Tuberculosis and Pulmonary Congenital immunodeficiencies, children who were premature: \<37 weeks gestational age.
• Use of other products containing probiotics in its composition with previous exposure or even study period.
• Infant in use of anti-leukotrienes.
• Use recent antibiotic.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Federal University of Pernambuco

Recife, Pernambuco, 50670-901, Brazil

Location

Related Publications (10)

• Rose MA, Stieglitz F, Koksal A, Schubert R, Schulze J, Zielen S. Efficacy of probiotic Lactobacillus GG on allergic sensitization and asthma in infants at risk. Clin Exp Allergy. 2010 Sep;40(9):1398-405. doi: 10.1111/j.1365-2222.2010.03560.x. Epub 2010 Jun 28.

  PMID: 20604800 BACKGROUND

• Kopp MV, Hennemuth I, Heinzmann A, Urbanek R. Randomized, double-blind, placebo-controlled trial of probiotics for primary prevention: no clinical effects of Lactobacillus GG supplementation. Pediatrics. 2008 Apr;121(4):e850-6. doi: 10.1542/peds.2007-1492. Epub 2008 Mar 10.

  PMID: 18332075 BACKGROUND

• Ozdemir O, Erol AY. Preventative and therapeutic probiotic use in allergic skin conditions: experimental and clinical findings. Biomed Res Int. 2013;2013:932391. doi: 10.1155/2013/932391. Epub 2013 Sep 1.

  PMID: 24078929 BACKGROUND

• Ozdemir O. Any role for probiotics in the therapy or prevention of autoimmune diseases? Up-to-date review. J Complement Integr Med. 2013 Aug 6;10:/j/jcim.2013.10.issue-1/jcim-2012-0054/jcim-2012-0054.xml. doi: 10.1515/jcim-2012-0054.

  PMID: 23921494 BACKGROUND

• Isolauri E, Rautava S, Salminen S. Probiotics in the development and treatment of allergic disease. Gastroenterol Clin North Am. 2012 Dec;41(4):747-62. doi: 10.1016/j.gtc.2012.08.007.

  PMID: 23101685 BACKGROUND

• Roessler A, Forssten SD, Glei M, Ouwehand AC, Jahreis G. The effect of probiotics on faecal microbiota and genotoxic activity of faecal water in patients with atopic dermatitis: a randomized, placebo-controlled study. Clin Nutr. 2012 Feb;31(1):22-9. doi: 10.1016/j.clnu.2011.08.012. Epub 2011 Oct 2.

  PMID: 21963389 BACKGROUND

• Azad MB, Coneys JG, Kozyrskyj AL, Field CJ, Ramsey CD, Becker AB, Friesen C, Abou-Setta AM, Zarychanski R. Probiotic supplementation during pregnancy or infancy for the prevention of asthma and wheeze: systematic review and meta-analysis. BMJ. 2013 Dec 4;347:f6471. doi: 10.1136/bmj.f6471.

  PMID: 24304677 BACKGROUND

• Abrahamsson TR, Jakobsson T, Bjorksten B, Oldaeus G, Jenmalm MC. No effect of probiotics on respiratory allergies: a seven-year follow-up of a randomized controlled trial in infancy. Pediatr Allergy Immunol. 2013 Sep;24(6):556-61. doi: 10.1111/pai.12104. Epub 2013 Jul 31.

  PMID: 23902407 BACKGROUND

• West CE, Hammarstrom ML, Hernell O. Probiotics in primary prevention of allergic disease--follow-up at 8-9 years of age. Allergy. 2013 Aug;68(8):1015-20. doi: 10.1111/all.12191. Epub 2013 Jul 30.

  PMID: 23895631 BACKGROUND

• Ismail IH, Licciardi PV, Tang ML. Probiotic effects in allergic disease. J Paediatr Child Health. 2013 Sep;49(9):709-15. doi: 10.1111/jpc.12175. Epub 2013 Apr 11.

  PMID: 23574636 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Diseases; Respiratory Sounds

Interventions

Beclomethasone; Probiotics; Lacteol

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Geórgia V. Araújo, Doctor

  Universidade Federal de Pernambuco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate in Allergy and Clinical Immunology.

Study Record Dates

• First Submitted: April 10, 2014
• First Posted: April 14, 2014
• Study Start: April 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

BR (1)