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

Stress Clinical Trial

Official title:

Evaluation of the Beneficial Effects of a Probiotic Product (Lactoflorene Plus) in Healthy Adult Subjects in Particular Psychological Stress Conditions.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03234452
• Other study ID #: Lactoflorene plus
• Status: Completed
• Phase: N/A
• Start date: March 23, 2016
• Est. completion date: April 18, 2017

Study information

• Verified date: September 2019
• Source: Montefarmaco OTC SpA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 18, 2017
• Est. primary completion date: July 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Pain
• Constipation
• Diarrhea
• Disbiosis
• Dysbiosis
• Stress

Intervention

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

Locations

Country	Name	City	State
Italy	Centro Ricerche Cliniche di Verona Srl,	Verona	(Vr)

Sponsors (1)

Lead Sponsor	Collaborator
Montefarmaco OTC SpA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NK activity	Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group	45 days
Secondary	IgA, IL8, TNF-Alpha, IL10		45 days
Secondary	Cortisol, alpha-amylase , chromogranin A		45 days
Secondary	microbiota composition investigation		45 days
Secondary	Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )		45 days