Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections

NCT05279534 | Terminated

• 1 other identifier: PROPED-URTI
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized, placebo-controlled trial to evaluate the coadjuvant effect of a combination of L. plantarum and P. acidilactici probiotic strains, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis. Main objective is to evaluate efficacy of this probiotic in reducing fever and pain, as well to evaluate its safety.

Conditions

Upper Respiratory Tract Infections; Pharyngitis; Tonsillitis

Keywords

Probiotic

Outcome Measures

Primary Outcomes (2)

• Daily evolution of fever

  Daily severity of fever (Celsius degrees), as measured with an infrared thermometer (same model for all recruited subjects) and noted in patient diary

  Day 1 to 15

• Daily evolution of pain

  Daily severity of pain, as per FLACC scale (Face, Legs, Activity, Cry and Consolability, ranging 0 \[no pain\] to 10 \[maximum pain\]) and noted in patient diary

  Day 1 to 15

Secondary Outcomes (22)

• Fever Area Under the Curve

  Day 1 to 60

• Pain Area Under the Curve

  Day 1 to 60

• Days with fever

  Day 1 to 60

• Days with pain

  Day 1 to 60

• Days with rhinorrhea

  Day 1 to 60

Other Outcomes (2)

• Etiology of the upper respiratory tract infection at baseline

  Day 1

• Salivary vitamin D at baseline

  Day 1

Study Arms (2)

Probiotic

EXPERIMENTAL

Active test product contains four lactic acid bacteria strains with Qualified Presumption of Safety (QPS) status by European Food Safety Authority (EFSA): Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, with maltodextrin (E1400, qs) as excipient, formulated in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0. Active test product is a food supplement and not an investigational medicinal product

Dietary Supplement: Probiotic

Control

PLACEBO COMPARATOR

The control study product is identical in packaging and formulation except that none of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485 and Pediococcus acidilactici CECT7483 (probiotic bacteria) are present. The Control product contains maltodextrin (E1400, qs) only, in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0.

Other: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, twice daily for 15 days

Probiotic

Placebo OTHER

Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0, twice daily for 15 days

Control

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children, 6 months to 5 years-old
• Diagnosed with upper respiratory tract infection with pharyngitis and/or tonsillitis by a physician
• With fever \>37.5 Celsius degrees and FLACC (Face, Legs, Activity, Cry and Consolability) score \>3
• Symptom onset no more than 48h before study entry
• Body weight at birth \>2500 gr
• Informed consent provided by parents or legal guardians

You may not qualify if:

• Failure to thrive
• Asthma or significant allergic disease
• Use of antibiotics, antivirals, probiotics or prebiotics for more than 48h within 2 weeks of study entry
• History of recurrent respiratory infections (\>2 otitis, \>1 severe sinusitis or \>1 pneumonia) within 12 months of study entry
• History of 2 or more invasive infections (meningitis, cellulitis, osteomyelitis, sepsis)
• Chronic diarrhea or short bowel syndrome
• Congenital heart or respiratory deficiency
• Known alpha1-antitrypsin deficiency
• Concurrent participation in other clinical trial(s)
• Other particular conditions which, in the judgment of the Principal Investigator, may interfere with the study

Sponsors & Collaborators

• AB Biotics, SA: lead
• Innovacion y Desarrollo de Estrategias en Salud: collaborator
• Hospital General Dr. Manuel Gea González: collaborator

Study Sites (1)

Hospital General Dr. Manuel Gea Gonzalez

Mexico City, Mexico DF, 14080, Mexico

Location

Related Publications (4)

• Manworren RC, Hynan LS. Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs. 2003 Mar-Apr;29(2):140-6.

  PMID: 12723828 BACKGROUND

• Gutierrez-Castrellon P, Gandara-Marti T, Abreu Y Abreu AT, Nieto-Rufino CD, Lopez-Orduna E, Jimenez-Escobar I, Jimenez-Gutierrez C, Lopez-Velazquez G, Espadaler-Mazo J. Probiotic improves symptomatic and viral clearance in Covid19 outpatients: a randomized, quadruple-blinded, placebo-controlled trial. Gut Microbes. 2022 Jan-Dec;14(1):2018899. doi: 10.1080/19490976.2021.2018899.

  PMID: 35014600 BACKGROUND

• Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1.

  PMID: 33789556 BACKGROUND

• Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.

  PMID: 9220806 BACKGROUND

MeSH Terms

Conditions

Respiratory Tract Infections; Pharyngitis; Tonsillitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Pedro Gutierrez-Castrellon, MD, PhD

  Hospital General Dr. Manuel Gea Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All study staff, including the Principal Investigator and the persons performing the subject assessments, will be blinded during the study. Sealed individual treatment code envelopes will be kept at the clinic to be able to break the code if any emergency occurs, as judged by the Investigator
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trials. Study subjects (6 months to 5 years-old) will be allocated to receive a combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and P. acidilactici CECT7483 (arm one) or placebo (arm two)

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 15, 2022
• Study Start: March 8, 2022
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: October 17, 2023

Record last verified: 2023-10

Locations

ME (1)