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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactoflorene plus | Experimental | 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 Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactoflorene plus | Dietary Supplement | 2 vials with dosing cap (10 mL) a day per os |
| |
| Measure | Description | Time Frame |
|---|---|---|
| NK activity | Verify that Natural Killer activities concentration is significantly higher in the experimental Group compared to the placebo group | 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| IgA, IL8, TNF-Alpha, IL10 | 45 days | |
| Cortisol, alpha-amylase , chromogranin A | 45 days | |
| microbiota composition investigation |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Ricerche Cliniche di Verona Srl, | Verona | (Vr) | 37100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30937345 | Derived | Soldi S, Tagliacarne SC, Valsecchi C, Perna S, Rondanelli M, Ziviani L, Milleri S, Annoni A, Castellazzi A. Effect of a multistrain probiotic (Lactoflorene(R) Plus) on inflammatory parameters and microbiota composition in subjects with stress-related symptoms. Neurobiol Stress. 2018 Nov 7;10:100138. doi: 10.1016/j.ynstr.2018.11.001. eCollection 2019 Feb. |
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| ID | Term |
|---|---|
| D064806 | Dysbiosis |
| D015746 | Abdominal Pain |
| D003248 | Constipation |
| D003967 | Diarrhea |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
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double-blind
| Placebo Lactoflorene plus |
| Dietary Supplement |
2 vials with dosing cap (10 mL) a day per os |
|
| 45 days |
| Gastrointestinal symptoms (abdominal pain, aerophagia, diarrhea, constipation, diarrhea/constipation alternation ) | 45 days |
| D012816 | Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |