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

NCT06860581 | Completed

• 2 other identifiers: 244/23506-786-03-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

young adults; supplementation; Lactobacillus helveticus; Bifidobacterium longum; stress markers; body composition; bone density; gut microbiota; diet

Outcome Measures

Primary Outcomes (3)

• Microbiota composition

  Analysis of the gut microbiota will be performed in faecal samples in SANPROBI Research and Development Center laboratory in Szczecin using Illumina next-generation sequencing technology.

  At baseline, and the first to third day after the completion of the 12-week intervention.

• Perceived stress intensity

  The PSS-10 (10-items Perceived Stress Scale) form was used to assess the intensity of stress related to one's own life experiences in the past month. Respondents reported on a 5-point Likert scale (0 = never, 1 = almost never, 2 = sometimes, 3 = quite often, 4 = very often) the extent to which situations in their lives during the past month were unpredictable, uncontrollable, and overwhelming. The scores for the four positively identified items (items 4, 5, 7, 8) are reversed. The maximum score is 40, with higher scores indicating higher levels of perceived stress. According to the instructions, scores in the range of 0-13 indicate a low level of stress, scores in the range of 14-26 indicate a moderate level of stress, and scores in the range of 27-40 indicate a high level of perceived stress.

  At baseline, and the first to third day after the completion of the 12-week intervention.

• Stress-related neuroendocrine markers

  Included: salivary cortisol, salivary DHEA and salivary cortisol:DHEA ratio, faecal cortisol. Unstimulated saliva samples were collected from fasting participants in disposable Eppendorf plastic tubes using the spitting method for 10 minutes while the subjects rested. Prior to analysis, samples will be warmed and centrifuged at 1000 x g for 20 minutes to remove particulate material. Cortisol and DHEA in human saliva will be measured with commercially available kits using an immunoenzymatic method according to the manufacturer's instructions. All samples will be processed in duplicate during the same assay. Faecal samples for cortisol analysis will be warmed and diluted with water, and the subsequent procedure is the same as for saliva samples prepared for cortisol analysis, as described above.

  At baseline, and the first to third day after the completion of the 12-week intervention.

Secondary Outcomes (5)

• Stress-coping strategies

  At baseline, and the first to third day after the completion of the 12-week intervention.

• Psychosomatic symptoms

  At baseline, and the first to third day after the completion of the 12-week intervention.

• Sense of coherence

  At baseline, and the first to third day after the completion of the 12-week intervention.

• Body composition

  At baseline, and the first to third day after the completion of the 12-week intervention..

• Bone density

  At baseline, and the first to third day after the completion of the 12-week intervention. .

Other Outcomes (3)

• Diet and lifestyle

  At baseline of the intervention.

• Socioeconomic status (SES)

  At baseline of the intervention.

• Personality dimensions

  At baseline of the intervention.

Study Arms (2)

Probiotic bacteria

EXPERIMENTAL

Bifidobacterium longum and Lactobacillus helveticus (Lh+Bl)

Dietary Supplement: Intervention (Sanprobi®Stress)

Placebo

PLACEBO COMPARATOR

Capsules containing only bulking agents (PLA).

Other: Placebo

Interventions

Intervention (Sanprobi®Stress) DIETARY_SUPPLEMENT

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.

Also known as: Lh+Bl

Probiotic bacteria

Placebo OTHER

Filling substances were only potato starch and magnesium stearate.

Also known as: PLA

Placebo

Eligibility Criteria

• Age: 20 Years - 30 Years
• Gender Eligibility Details: Only biological women are eligibilitible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• female sex,
• age 20-30 years,
• BMI \< 30 kg/m2

You may not qualify if:

• diagnosed chronic and/or serious health disorders (e.g. diabetes, asthma, hypertension, renal diseases),
• pregnancy,
• taking any probiotics for 8 weeks prior to enrollment to the study protocol, -
• recent and current antibiotic treatment, ore use of pharmaceutical antidepressant treatment

Sponsors & Collaborators

• Poznan University of Life Sciences: lead

Study Sites (1)

Poznan University of Life Sciences, Department of Human Nutrition and Dietetics

Poznan, Greater Poland Voivodeship, 60-461, Poland

Location

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MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Boguslaw Stelcer, PhD

  Poznan University of Life Sciences

  STUDY CHAIR

• Magdalena Czlapka-Matyasik, PhD

  Poznan University of Life Sciences

  PRINCIPAL INVESTIGATOR

• Malgorzata Wozniewicz, PhD

  Poznan University of Life Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Neither the researchers nor the participants knew whether intervention or placebo was administered. The preparations were administrated to each participant in envelopes marked with a unique code. The supplements were in the same capsules as the plecebo and could not be distinguished by appearance and taste. Assignment of study material (A - placebo or B - intervention) to individuals was randomised by computer-generated codes, using Research Randomizer (www.randomizer.org), obtained from the supplement manufacturer. The study was decoded after results collection was completed.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Experimental dubleblinded study with interventional and placebo equal goups

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 6, 2025
• Study Start: September 26, 2023
• Primary Completion: December 12, 2023
• Study Completion: March 18, 2024
• Last Updated: March 6, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)