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OpenTrials
Completed

NCT Number: NCT03234452

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

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.

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Key information

Conditions

Disbiosis Abdominal Pain Constipation Diarrhea Dysbiosis Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stress

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Ricerche Cliniche di Verona Srl,

Verona, (Vr), 37100, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lactoflorene plus

Dietary Supplement

2 vials with dosing cap (10 mL) a day per os

Placebo Lactoflorene plus

Dietary Supplement

2 vials with dosing cap (10 mL) a day per os

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefarmaco OTC SpA

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 31, 2017
Registry last updated
Sep 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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