Probiotics in Prevention of Common Cold

Probi AB

Status: Completed

Conditions: Viral Infections of the Upper Respiratory Tract

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02013934

PAB/011013

Details and patient eligibility

About

The objective of this study is to assess the benefit and tolerability of a probiotic product in subjects with increased susceptibility to common cold.

Enrollment: 899 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• males and females
• age 18-70 years
• increased risk for common cold (at least 4 episodes within 12 months)
• commitment to adhere to former diet and physical activity
• commitment not to use any products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) during the study (except for rescue medication, see 7.5)
• women of child-bearing potential have to agree to use appropriate birth control methods Written consent of the subject to participate is a prerequisite for study participation.

Exclusion criteria

• acute / chronic upper / lower airways disease
• chronic cough of any origin
• any allergic reaction that may influence the study outcome (e.g. acute/chronic rhinitis)
• history of nasal reconstructive surgery
• presence of nasal ulcers or nasal polyps
• severe nasal septum deviation or other condition that could cause nasal obstruction
• congenital or acquired immunodeficiency disease (e.g. HIV infection)
• Bechterew's disease
• body temperature above 37.5°C
• suspected swine flu or influenza
• vaccination with a vaccine containing an adjuvant within 3 months prior to study start and during the study
• vaccination with a vaccine not containing an adjuvant within 6 weeks prior to study start and during the study
• stomach/gastrointestinal diseases
• serious organ or systemic diseases
• sleep disorder
• psychiatric disorders
• known sensitivity to the ingredients of the investigational product
• regular intake of products that may influence the study outcome (e.g. immune suppressants/immune stimulants, including paramedication such as e.g. Echinacea, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, influenza remedies, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, probiotics) within the last 4 weeks prior to study start
• habitual usage of nasal drops/spray
• pregnancy or nursing
• alcohol / drug abuse
• simultaneous participation in another clinical trial or participation in a clinical trial within the last 30 days
• insufficient compliance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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899 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

Dietary supplement

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Dietary supplement

Treatment:

Dietary Supplement: Placebo