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

M

Montefarmaco

Status

Completed

Conditions

Disbiosis
Diarrhea
Constipation
Stress
Abdominal Pain

Treatments

Dietary Supplement: Lactoflorene plus
Dietary Supplement: Placebo Lactoflorene plus

Study type

Interventional

Funder types

Industry

Identifiers

NCT03234452
Lactoflorene plus

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

50 participants in 2 patient groups, including a placebo group

Lactoflorene plus
Experimental group
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
Treatment:
Dietary Supplement: Lactoflorene plus
Placebo Lactoflorene plus
Placebo Comparator group
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.
Treatment:
Dietary Supplement: Placebo Lactoflorene plus

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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