NCT05656729

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

Studio Clinico Randomizzato in Doppio Cieco, Controllato Verso Placebo, a Gruppi Paralleli, Sull'efficacia Clinica Di Un Prodotto a Base Di Probiotici Nel Migliorare I Comuni Sintomi Da Raffreddamento E La Risposta Immunitaria in Adulti Sani - ImmunoCold 2021

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 18 Years – 44 Years
• Healthy volunteers: Accepted

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

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

• Cold Symptom

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	DefensePlus	Multistrain probiotic:L. plantarum PBS077, L. acidophilus PBS066, B. lactis BL050, Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide
DIETARY_SUPPLEMENT	Placebo	Maltodextrins, Vitamin B12, Vitamin, B6 Folic acid, Magnesium, silicon dioxide

Timeline

• Start date: 2022-12-22
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2022-12-19
• Last updated: 2024-12-06

Locations

1 site across 1 country: Italy