Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05577065
Other study ID # CTB2022TN108
Secondary ID AFCRO158
Status Recruiting
Phase N/A
First received
Last updated
Start date January 30, 2023
Est. completion date May 30, 2024

Study information

Verified date April 2024
Source The Archer-Daniels-Midland Company
Contact ADM Medical Team
Phone +44 1460 243 230
Email medical@protexin.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date May 30, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 8 Years
Eligibility Inclusion Criteria: 1. Have a parent/guardian able to give written informed consent. 2. If =7 years, be able to give written informed assent. 3. Healthy children aged 2 - 8 years old. 4. In general good health, as determined by the investigator. 5. Attending a registered childcare provider or school. 6. Willing to consume the study product daily for the duration of the study. Exclusion Criteria: 1. Has URTI symptoms at the time of randomisation. 2. Are <2 or =9 years old. 3. Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects. 4. Has a family household member that smokes cigarettes in the home. 5. Has taken antibiotics within the previous 2 weeks prior to randomisation. 6. Has taken probiotic supplements within the previous 2 weeks prior to randomisation 7. Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed). 8. Has any significant health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. 9. Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. 10. Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed). 11. Has a gastrointestinal or chronic infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases. 12. Planned extensive travel (for >1 month) during the study duration. 13. Parent/guardian who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study. 14. Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial/study, these must have been completed not less than 60 days prior to this study. 15. Any Participant who is the child of an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Probiotic
Single strain probiotic in the form of a sachet with a daily dose of 3E+9 Colony Forming Unit (CFU) per day for 26 weeks.
Placebo
Matching placebo in the form of a sachet once daily for 26 weeks

Locations

Country Name City State
Ireland Atlantia Food Clinical Trials Cork

Sponsors (2)

Lead Sponsor Collaborator
The Archer-Daniels-Midland Company Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Other Faecal Microbiome analysis Shallow shotgun metagenomic sequencing for 20% of cohort Day 0, Day 180
Primary Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI) Presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline Entire follow up period (total of 180 days)
Secondary Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI The presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline Day 0, Day 90, Day 180
Secondary Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants Duration of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline Day 0, Day 90, Day 180
Secondary Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants Severity of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline Day 0, Day 90, Day 180
Secondary Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline Day 0, Day 90, Day 180
Secondary Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline Day 0, Day 90, Day 180
Secondary Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL) Measured via saliva sample Day 0, Day 180
Secondary Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline Day 0, Day 90, Day 180
See also
  Status Clinical Trial Phase
Completed NCT01158560 - A Trial of Vitamin D and Health Advice for the Prevention of Upper Respiratory Tract Infections Phase 3
Completed NCT00965822 - A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population Phase 2
Completed NCT01019889 - Effect of Socheongryong-tang and Yeongyopaedok-san in Upper Respiratory Tract Infection Phase 3
Not yet recruiting NCT05484102 - Preventive Effect of Cow's Milk Fermented With Lactobacillus Paracasei CBA L74 on Common Infectious Diseases in Children N/A
Recruiting NCT05804123 - LiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Media N/A
Completed NCT01773824 - Routine Prescription Feedback and Peer Comparison to Lower Antibiotic Prescriptions in Primary Care N/A
Terminated NCT01964885 - Benefit and Tolerability of IQP-AS-105 in Reducing Susceptibility to Upper Respiratory Tract Infections Phase 3
Completed NCT01883427 - Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children Phase 2
Completed NCT01215682 - Vitamin D Supplementation and Upper Respiratory Tract Infections in Adolescent Swimmers N/A
Completed NCT04019730 - The Effect of a Ketogenic Diet on the Exercise Induced Immune Response N/A
Completed NCT01604096 - Controlled Trial to Evaluate a Local Information Campaign on Antibiotic Prescribing in Italy Phase 2
Recruiting NCT06149494 - RCT of Vapendavir in Patients With COPD and Human Rhinovirus/Enterovirus Upper Respiratory Infection Phase 2
Completed NCT03463694 - Edinburgh and Lothian Virus Intervention Study in Kids N/A
Completed NCT06127186 - Phenotype of Headache and Facial Pain in Upper Respiratory Tract Infections
Completed NCT03198676 - A Safety Study to Compare the Effect of Two PrEP-001 Nasal Powder Formulations on Nasal Mucosa and Serum Cytokine Production Phase 1
Withdrawn NCT05557214 - Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers N/A
Completed NCT01893762 - Innate Immune Response to (An)Aerobic Exercise in Rowing Athletes N/A
Completed NCT01396889 - Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years N/A
Completed NCT01129128 - Three Arm Trial of Immune Effects of Echinacea N/A
Completed NCT05252468 - COVID-19 Prevention Trial: Effect of Prophylactic Use of TAFFIX™ on Infection Rate by SARS-CoV-2 Virus (COVID-19). N/A