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Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03234452
Recruitment Status : Completed
First Posted : July 31, 2017
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Montefarmaco OTC SpA

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.

Condition or disease Intervention/treatment Phase
Disbiosis Abdominal Pain Constipation Diarrhea Stress Dietary Supplement: Lactoflorene plus Dietary Supplement: Placebo Lactoflorene plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-blind
Primary Purpose: Treatment
Official Title: Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.
Actual Study Start Date : March 23, 2016
Actual Primary Completion Date : July 21, 2016
Actual Study Completion Date : April 18, 2017

Arm Intervention/treatment
Experimental: Lactoflorene plus
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
Dietary Supplement: Lactoflorene plus
2 vials with dosing cap (10 mL) a day per os

Placebo Comparator: Placebo Lactoflorene plus
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.
Dietary Supplement: Placebo Lactoflorene plus
2 vials with dosing cap (10 mL) a day per os




Primary Outcome Measures :
  1. NK activity [ Time Frame: 45 days ]
    Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group


Secondary Outcome Measures :
  1. IgA, IL8, TNF-Alpha, IL10 [ Time Frame: 45 days ]
  2. Cortisol, alpha-amylase , chromogranin A [ Time Frame: 45 days ]
  3. microbiota composition investigation [ Time Frame: 45 days ]
  4. Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation ) [ Time Frame: 45 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03234452


Locations
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Italy
Centro Ricerche Cliniche di Verona Srl,
Verona, (Vr), Italy, 37100
Sponsors and Collaborators
Montefarmaco OTC SpA
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Montefarmaco OTC SpA
ClinicalTrials.gov Identifier: NCT03234452    
Other Study ID Numbers: Lactoflorene plus
First Posted: July 31, 2017    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Montefarmaco OTC SpA:
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
Additional relevant MeSH terms:
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Constipation
Diarrhea
Abdominal Pain
Dysbiosis
Signs and Symptoms, Digestive
Signs and Symptoms
Pain
Neurologic Manifestations
Pathologic Processes