Back to resultsEvaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
Primary Purpose
Disbiosis, Abdominal Pain, Constipation
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lactoflorene plus
Placebo Lactoflorene plus
Sponsored by
About this trial
This is an interventional treatment trial for Disbiosis focused on measuring Lactoflorene plus, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus acidophilus, LA-5®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431®, Inflammation, gut permeability, disbiosis, probiotic, IgA, IL10
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.
Sites / Locations
- Centro Ricerche Cliniche di Verona Srl,
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lactoflorene plus
Placebo Lactoflorene plus
Arm Description
10 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
Identical 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.
Outcomes
Primary Outcome Measures
NK activity
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
Secondary Outcome Measures
IgA, IL8, TNF-Alpha, IL10
Cortisol, alpha-amylase , chromogranin A
microbiota composition investigation
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03234452
Brief Title
Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
Official Title
Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
July 21, 2016 (Actual)
Study Completion Date
April 18, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefarmaco OTC SpA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disbiosis, Abdominal Pain, Constipation, Diarrhea, Stress
Keywords
Lactoflorene plus, Bifidobacterium animalis subsp. lactis, BB-12®, Lactobacillus acidophilus, LA-5®, Lactobacillus paracasei subsp. paracasei, L. CASEI 431®, Inflammation, gut permeability, disbiosis, probiotic, IgA, IL10
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lactoflorene plus
Arm Type
Experimental
Arm Description
10 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
Arm Title
Placebo Lactoflorene plus
Arm Type
Placebo Comparator
Arm Description
Identical 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactoflorene plus
Intervention Description
2 vials with dosing cap (10 mL) a day per os
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo Lactoflorene plus
Intervention Description
2 vials with dosing cap (10 mL) a day per os
Primary Outcome Measure Information:
Title
NK activity
Description
Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group
Time Frame
45 days
Secondary Outcome Measure Information:
Title
IgA, IL8, TNF-Alpha, IL10
Time Frame
45 days
Title
Cortisol, alpha-amylase , chromogranin A
Time Frame
45 days
Title
microbiota composition investigation
Time Frame
45 days
Title
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Most important exclusion criteria were history or diagnosis of GI disease, oral antibiotics within 30 days prior to the screening visit, and use of drugs, food or herbal supplements for digestive symptoms.
Facility Information:
Facility Name
Centro Ricerche Cliniche di Verona Srl,
City
Verona
State/Province
(Vr)
ZIP/Postal Code
37100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30937345
Citation
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.
Results Reference
derived
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Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
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