Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
1 other identifier
interventional
50
1 country
1
Brief Summary
A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of inflammation and intestinal barrier function and gastrointestinal symptoms in healthy volunteers with self-reported anxiety.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 18, 2017
CompletedFirst Submitted
Initial submission to the registry
July 26, 2017
CompletedFirst Posted
Study publicly available on registry
July 31, 2017
CompletedSeptember 9, 2019
September 1, 2019
4 months
July 26, 2017
September 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
NK activity
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
45 days
Secondary Outcomes (4)
IgA, IL8, TNF-Alpha, IL10
45 days
Cortisol, alpha-amylase , chromogranin A
45 days
microbiota composition investigation
45 days
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
45 days
Study Arms (2)
Lactoflorene plus
EXPERIMENTAL10 ml mixture of Lactobacillus acidophilus LA-5®, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431® , Bacillus coagulans BC513, zinc and B-vitamins (niacin, B1, B2, B5, B6, B12 and folic acid) twice a day
Placebo Lactoflorene plus
PLACEBO COMPARATORIdentical placebo mixture without probiotics, B-vitamins and zinc. The active and placebo products had similar appearance, taste and smell and were provided in identical bottles of 10 ml with identical labelling.
Interventions
2 vials with dosing cap (10 mL) a day per os
Eligibility Criteria
You may qualify if:
- Eligible subjects were healthy men and women, 20-35 years old, with a STAI scale, form Y, module 1 (state anxiety) score of ≥ 35 and ≥40, for men and women, respectively.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centro Ricerche Cliniche di Verona Srl,
Verona, (Vr), 37100, Italy
Related Publications (1)
Soldi S, Tagliacarne SC, Valsecchi C, Perna S, Rondanelli M, Ziviani L, Milleri S, Annoni A, Castellazzi A. Effect of a multistrain probiotic (Lactoflorene(R) Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms. Neurobiol Stress. 2018 Nov 7;10:100138. doi: 10.1016/j.ynstr.2018.11.001. eCollection 2019 Feb.
PMID: 30937345DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- double-blind
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2017
First Posted
July 31, 2017
Study Start
March 23, 2016
Primary Completion
July 21, 2016
Study Completion
April 18, 2017
Last Updated
September 9, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share