CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Intervention (Sanprobi®Stress) +1 moredietary
Likely dose
Not stated in record
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Search/NCT06860581
NCT06860581N/ACompleted

The Impact of Dietary Supplementation With Lactobacillus Helveticus and Bifidobacterium Longum on the Functioning of the Brain-gut Axis, in the Context of Mental Health, Eating Patterns and Nutritional Status of Young Adults

Poznan University of Life Sciences·interventional·Posted Mar 6, 2025·Updated Mar 6, 2025

In Brief

A clinical study evaluating Intervention (Sanprobi®Stress) and Placebo for Healthy Volunteers and 2 related conditions. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Research on probiotic supplementation in the prevention and treatment of depressive and anxiety disorders and stress coping skills has been conducted for many years. This research project was designed to investigate the effects of both, probiotic supplementation and diet quality on a wide range of psychological, microbiological, biochemical, and clinical outcomes. The aim of the study was to assess the effects of targeted supplementation with Lactobacillus helveticus and Bifidobacterium longum on gut microbiota composition and quality, mental health, perceived stress intensity, psychosomatic response, and coping as well as body composition and bone density in young women who differed in diet quality. The study enrolled 120 healthy women in early adulthood (20-30 years of age) who were equally and randomly assigned to the intervention (Lh+Bl) or placebo (PLA) group. The intervention consisted of the administration of combined freeze-dried strains of Bifidobacterium longum Rosell®-175 and Lactobacillus helveticus Rosell®-52 (Lh+Bl) at dose of one capsule per day for 12 weeks. The total bacterial content per capsule was 3x109 CFU. At baseline, dietary habits were assessed using the KomPAN FFQ questionnaire and faecal samples were collected for gut microbiota analysis using Illumina next-generation sequencing technology. Anthropometric measurements were taken, and body composition and bone density were assessed using DEXA and displacement plethysmography using Bod Pod. Perceived stress and mental health were assessed using the psychological scales: PSS 10, Mini Cope, GHQ 28, and SOC-13. Salivary cortisol, DHEA and cortisol:DHEA ratio were measured as physiological markers of stress. After 12 weeks of supplementation, measurements were repeated and compared with baseline values.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesPoland
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedMar 6, 2025
Enrollment StartSep 26, 2023
Primary CompletionDec 12, 2023
Study CompletionMar 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.3 years ago

Interventions

Intervention (Sanprobi®Stress)dietary

The composition of lyophilized strains of Bifidobacterium longum Rosell®-175 and Lactobacillus helveticus Rosell®-52 (trade name: Sanprobi®Stress; manufacturer: Sanprobi sp. z o.o. sp. k., Szczecin, Poland) was placed in capsules, the shell of which consisted of hydroxypropylmethylcellulose. The total bacterial content per capsule was 3x109 CFU. Filling substances were potato starch and magnesium stearate. The weight of the capsule was 420 mg. Dosage: 1 capsule/day for 12 weeks.

Placeboother

Filling substances were only potato starch and magnesium stearate.