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

Not Applicable

Completed

• Conditions: Disbiosis; Constipation; Abdominal Pain; Diarrhea; Stress
• Interventions: Dietary Supplement: Lactoflorene plus; Dietary Supplement: Placebo Lactoflorene plus

• Registration Number: NCT03234452
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-23
• Primary Completion: 2016-07-21
• Study Completion: 2017-04-18
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-26
• Study First Posted: 2017-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-06
• Last Update Posted: 2019-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lactoflorene plus	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
Placebo Lactoflorene plus	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.

Primary Outcome Measures

Name	Time	Method
NK activity	45 days	Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group

Secondary Outcome Measures

Name	Time	Method
microbiota composition investigation	45 days
IgA, IL8, TNF-Alpha, IL10	45 days
Cortisol, alpha-amylase , chromogranin A	45 days
Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation )	45 days

Trial Locations

Locations (1)

Centro Ricerche Cliniche di Verona Srl,; 🇮🇹 Verona, (Vr), Italy