CompletedNCT05656729Updated Dec 6, 2024

Effect of a Multistrain Probiotic on Cold Symptoms in Healthy Patients with an History of Upper Airways Infection

An interventional study of DefensePlus and Placebo in Cold Symptom, sponsored by Università degli Studi di Ferrara. Completed at 1 site in Italy. Open to participants aged 18 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-06.

Sponsored by Università degli Studi di Ferrara · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 50
Allocation: Randomized
Ages: 18 Years to 44 Years
Sex: All

Study summary

The study is a double-blind randomized clinical trial which aims to evaluate the efficacy of a multi strain probiotic in human adults in controlling and improving cold symptoms and inflammatory response

Read the detailed description

Adult subjects (age 18-44) with a history of upper airways infection, will be assigned to placebo or probiotic groups and take either placebo or probiotic dietary intervention for 12 weeks. After that, a 6 weeks follow-up. The answers at: Common Cold Questionnarie (CCQ), Wisconsin Upper Respiratory Symptoms Survey-21 (WURSS-21) and quality of life score (SF-36) will be compared in the two groups. In addition, serological markers (blood count, lymphocyte subpopulation (B, T, T4, T8, NK), IFN-γ and IL-10 levels) will be evaluated over a 18 week period.

Conditions studied

Cold Symptom

Keywords

cold
cold symptoms
probiotics

In context

Lead sponsor

Università degli Studi di Ferrara is the lead sponsor of 64 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 44 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

people who:

are willing and capable of joining the study
are willing of not varying their routine (lifestyle, physical activity..) during the study
are willing of not varying their diet during the study
are willing of using only the testing product during the study
are willing of not using products that may interfere with the testing product
have not recently joined similar studies
have signed informed consent

Exclusion criteria

Exclusion Criteria:

subjects:

not filling the inclusion criteria
with suspected or confirmed sensibility to one or more product component
with chronic diseases (cardiovascular congenital diseases, hepatic diseases, renal disease, immunodeficiency)
undergoing antibiotic/pharmacological treatment
with other concomitant disease (infective, respiratory, gastrointestinal, immune)
who underwent an immunomodulating treatment in the past 4 weeks
who underwent an immunosuppressant therapy in the past 3 months
with severe disease ongoing
who abuse of alcohol and/or drugs
who are considered not eligible by the investigator
not able to communicate due to language barriers, mental issues or cerebral functioning impairment

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 50 participants (actual)

Study arms

Placebo comparator
Placebo
Placebo 8-week daily administration
Dietary Supplement: Placebo
Active comparator
Multistrain probiotic
Dietary Supplement: Multistrain Probiotic 12-week daily administration
Dietary Supplement: DefensePlus

Interventions

Dietary supplementDefensePlus
Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
Dietary supplementPlacebo
Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide

What researchers measure

Primary outcomes

Cold symptoms evaluation
Cold symptoms will be evaluated before and after treatment through Common Cold Questionnaire(CCQ). Highest score: 27, Lowest 0. Higher scores indicate worst symptoms
Time frame: 18 weeks

Secondary outcomes

Change of Wisconsin Upper Respiratory Symptoms Survey (WURSS-21)
Changes of WURSS-21 questionnaire will be assessed before and after treatment. Highest score: 147, Lowest 0. Higher scores indicate worst symptoms
Time frame: 18 weeks
Change of Short Form Health Survey 36 (SF-36)
Higher score on Short Form Health Survey 36 (SF-36) questionnaire will be considered as an improvement of life quality. Highest score: 147, Lowest 0. Higher scores indicate better perception of one's health
Time frame: 18 weeks
Inflammatory status
A reduction of inflammatory markers (INF-y, IL-10, and lymphocite B, T, T4, T8, NK) will be considered as an improvement of inflammatory status
Time frame: 18 weeks

Study locations

1 site

Azienda Ospedaliero Universitaria di Ferrara
Ferrara, 44124, Italy

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05656729
Lead sponsor: Università degli Studi di Ferrara
Responsible party: Giacomo Caio (Professor, Università degli Studi di Ferrara) — Principal investigator
First posted: Dec 19, 2022
Start date: Dec 22, 2022
Primary completion: Jul 30, 2024
Completion: Jul 30, 2024
Last update: Dec 6, 2024

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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