The Impact of Selected Probiotic Bacteria on Gut Microbiota, Stress Indicators and Nutritional Status of Young Adults

NCT06860581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-06

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers
  • Young Adult
  • Women

Interventions

DIETARY_SUPPLEMENT

Intervention (Sanprobi®Stress)

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.

OTHER

Placebo

Filling substances were only potato starch and magnesium stearate.

Sponsors & Collaborators

  • Poznan University of Life Sciences

    lead OTHER

Principal Investigators

  • Boguslaw Stelcer, PhD · Poznan University of Life Sciences

  • Magdalena Czlapka-Matyasik, PhD · Poznan University of Life Sciences

  • Malgorzata Wozniewicz, PhD · Poznan University of Life Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
30 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2023-12-12
Completion
2024-03-18

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860581 on ClinicalTrials.gov