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

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