Probiotics in Prevention of Common Cold

NCT02013934 | Completed DMC

• 1 other identifier: PAB/011013
• Study Type: interventional
• Target: 899
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Viral Infections of the Upper Respiratory Tract

Outcome Measures

Primary Outcomes (1)

• Severity of cold symptoms

  Severity of cold symptoms based on the questionnaire WURSS-21 during the cold episodes throughout the study period, in comparison between verum and placebo group

  3 months

Secondary Outcomes (1)

• Incidence of common cold episodes

  3 months

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

Dietary supplement

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Dietary supplement

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

Probiotics

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Probi AB: lead

Study Sites (1)

A&R

Berlin, Germany

Location

Related Publications (1)

• Ahren IL, Hillman M, Nordstrom EA, Larsson N, Niskanen TM. Fewer Community-Acquired Colds with Daily Consumption of Lactiplantibacillus plantarum HEAL9 and Lacticaseibacillus paracasei 8700:2. A Randomized, Placebo-Controlled Clinical Trial. J Nutr. 2021 Jan 4;151(1):214-222. doi: 10.1093/jn/nxaa353.

  PMID: 33296464 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2013
• First Posted: December 17, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 17, 2016
• Last Updated: April 17, 2018

Record last verified: 2013-12

Locations

DE (1)