Trial Outcomes & Findings for Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers (NCT NCT05567653)
NCT ID: NCT05567653
Last Updated: 2026-02-20
Results Overview
• gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next-Generation Sequencing);
COMPLETED
NA
26 participants
Baseline and 3 months
2026-02-20
Participant Flow
A total of 51 female dancers were screened; 26 met inclusion criteria (age 18-36, \>8 hours of weekly training). Twenty-five were excluded due to recent illness, supplementation, medication, or travel. Participation was challenging due to dancers' long training hours, performances, and irregular schedules, limiting availability for fasting blood draws and timely stool sample delivery. As only two men applied, the final sample included women only to avoid sex-related bias in microbiome outcomes.
Although 20 participants were randomized and assigned to groups (8 in PRO, 12 in PLA), only 17 completed the study. Three withdrew before receiving the intervention or failed to follow-up. The Protocol Enrollment field reflects only the final number analyzed per protocol.
Participant milestones
| Measure |
Probiotic Treatment Group (PRO)
Final sample: 5 participants (out of \~30 originally planned). Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress): 3-month, multi-strain probiotic supplementation (one capsule daily, 3 × 10⁹ CFU).
Note: Several participants withdrew or were excluded due to non-adherence or outlier data (e.g., failure to start supplementation, extreme biochemical values).
|
Placebo Group (PLA)
Final sample: 11 participants (out of \~30 originally planned). Starch (placebo): 3-month placebo supplementation (one capsule daily). Note: Some participants were excluded due to early withdrawal or failure to complete the protocol.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
12
|
|
Overall Study
COMPLETED
|
6
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Probiotic Treatment Group (PRO)
Final sample: 5 participants (out of \~30 originally planned). Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress): 3-month, multi-strain probiotic supplementation (one capsule daily, 3 × 10⁹ CFU).
Note: Several participants withdrew or were excluded due to non-adherence or outlier data (e.g., failure to start supplementation, extreme biochemical values).
|
Placebo Group (PLA)
Final sample: 11 participants (out of \~30 originally planned). Starch (placebo): 3-month placebo supplementation (one capsule daily). Note: Some participants were excluded due to early withdrawal or failure to complete the protocol.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Effects of Probiotics on Gut Microbiota, Endocannabinoid and Immune Activation and Symptoms of Fatigue in Dancers
Baseline characteristics by cohort
| Measure |
Probiotic Treatment Group (PRO)
n=8 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=12 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.82 years
STANDARD_DEVIATION 1.01 • n=14 Participants
|
20.36 years
STANDARD_DEVIATION 0.98 • n=14 Participants
|
20.14 years
STANDARD_DEVIATION 1.00 • n=29 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
12 Participants
n=14 Participants
|
20 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=14 Participants
|
12 Participants
n=14 Participants
|
20 Participants
n=29 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=29 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=14 Participants
|
12 participants
n=14 Participants
|
20 participants
n=29 Participants
|
|
Body weight
|
59.50 kilograms
STANDARD_DEVIATION 6.01 • n=14 Participants
|
58.40 kilograms
STANDARD_DEVIATION 6.56 • n=14 Participants
|
58.84 kilograms
STANDARD_DEVIATION 6.21 • n=29 Participants
|
|
Body fat %
|
27.05 Body mass percentage
STANDARD_DEVIATION 2.37 • n=14 Participants
|
27.16 Body mass percentage
STANDARD_DEVIATION 3.73 • n=14 Participants
|
27.12 Body mass percentage
STANDARD_DEVIATION 3.18 • n=29 Participants
|
|
Physical activity level
|
16.11 Hours per week
STANDARD_DEVIATION 7.93 • n=14 Participants
|
17.15 Hours per week
STANDARD_DEVIATION 6.40 • n=14 Participants
|
16.73 Hours per week
STANDARD_DEVIATION 6.87 • n=29 Participants
|
|
Handgrip strength
|
26.26 kilograms
STANDARD_DEVIATION 4.14 • n=14 Participants
|
28.01 kilograms
STANDARD_DEVIATION 4.35 • n=14 Participants
|
27.31 kilograms
STANDARD_DEVIATION 4.25 • n=29 Participants
|
|
Energy intake
|
2289.10 kilocalories
STANDARD_DEVIATION 362 • n=14 Participants
|
2021.50 kilocalories
STANDARD_DEVIATION 264 • n=14 Participants
|
2134.42 kilocalories
STANDARD_DEVIATION 310 • n=29 Participants
|
|
Mediterranean diet adherence score
|
6.10 units on a scale
STANDARD_DEVIATION 2.30 • n=14 Participants
|
5.50 units on a scale
STANDARD_DEVIATION 1.75 • n=14 Participants
|
5.74 units on a scale
STANDARD_DEVIATION 2.00 • n=29 Participants
|
|
White blood cells
|
5.90 cells x10^9/L
STANDARD_DEVIATION 1.00 • n=14 Participants
|
5.60 cells x10^9/L
STANDARD_DEVIATION 0.78 • n=14 Participants
|
5.73 cells x10^9/L
STANDARD_DEVIATION 0.88 • n=29 Participants
|
|
Lymphocytes
|
2.55 cells x10^9/L
STANDARD_DEVIATION 0.40 • n=14 Participants
|
2.40 cells x10^9/L
STANDARD_DEVIATION 0.60 • n=14 Participants
|
2.46 cells x10^9/L
STANDARD_DEVIATION 0.53 • n=29 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Stool samples were collected at baseline and post-intervention according to the study protocol; however, the planned sequencing and metagenomic analyses were not performed due to lack of funding and laboratory resources. Consequently, no outcome data were generated for this Outcome Measure, no participants were analyzed (0 in each arm), and no statistical analyses were performed. No future analyses are planned for this Outcome Measure.
• gut bacteria species in stool will be assessed using the shallow shotgun sequencing method, NGS (Next-Generation Sequencing);
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Stool samples were collected at baseline and at 3 months according to the study protocol. However, due to lack of funding and laboratory resources, the planned next-generation sequencing and metagenomic analyses were not performed, and no quantitative microbiota data were generated. Consequently, no participants were analyzed for this Outcome Measure (0 in each arm), no statistical analyses were conducted, and no future analyses are planned for this Outcome Measure.
• determination of quantitative (Colony forming units - CFU) changes in bacteria in the stool - the shallow shotgun sequencing method, NGS (Next Generation Sequencing) molecular analysis will be used to assess the changes;
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Stool samples were collected according to the study protocol. Due to financial and laboratory resource limitations, metabolomic analyses were performed only for participants in the probiotic treatment group, and no metabolomic data were generated for the placebo group. Consequently, participants in the probiotic group with available metabolomic data were analyzed for this Outcome Measure. No additional metabolomic analyses are planned for PLA group for this Outcome Measure.
Metabolites with fold change \>1.5 and p\<0.05 were considered significantly altered. The reported values represent the number of metabolites meeting these criteria in the probiotic group. • metabolomic analysis (non-targeted metabolome, short-chain fatty acids, trimethylamines, tryptophan catabolites) will be performed on a quadrupole mass spectrometer coupled with a time-of-flight (QToF) analyzer connected to the high performance liquid chromatograph (UHPLC).
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Intestinal Metabolome in Stool Samples
|
16 metabolites
|
—
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of endocannabinoids and cannabinoid receptors: anandamide (AEA) using ELISA Kit (nanograms per millilitre (ng/mL));
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Endocannabinoids Levels in Blood Samples
|
-1.11 ng/mL
Standard Deviation 35.90
|
14.08 ng/mL
Standard Deviation 56.63
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of cannabinoid receptors: Endocannabinoid Receptor 2 (CNR2) using ELISA Kit (nanograms per millilitre (ng/mL));
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Endocannabinoids' Receptors Levels in Blood Samples
|
-0.26 ng/mL
Standard Deviation 0.29
|
-0.14 ng/mL
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of cannabinoid metabolism enzymes: fatty acid amide hydrolase (FAAH) using ELISA Kit (nanograms per millilitre (ng/mL));
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Endocannabinoids Metabolism Enzymes in Blood
|
0.09 ng/mL
Standard Deviation 0.71
|
0.48 ng/mL
Standard Deviation 1.11
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and at 3 months according to the study protocol. However, due to lack of funding and laboratory resources, ELISA-based quantification of intestinal barrier biomarkers (zonulin and calprotectin) was not performed, and no outcome data were generated. Consequently, no participants were analyzed for this Outcome Measure (0 in each arm), no statistical analyses were conducted, and no future analyses are planned for this Outcome Measure.
• determination of blood biomarkers of a disturbed intestinal barrier concentrations: zonulin, calprotectin (CALPRO) using ELISA Kit (nanograms per millilitre (ng/mL));
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of blood biomarkers of a disturbed intestinal barrier concentrations: lipopolysaccharide (LPS), using ELISA Kit (picograms per millilitre (pg/mL));
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Intestinal Barrier Biomarkers in Blood Samples
|
3.48 pg/mL
Standard Deviation 81.67
|
56.98 pg/mL
Standard Deviation 82.96
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of blood tumor necrosis factor-alpha (TNF-α) concentration using ELISA Kit (nanograms per millilitre (ng/mL));
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Tumor Necrosis Factor-alpha (TNF-α) in Blood Samples
|
10.28 pg/mL
Standard Deviation 10.89
|
7.15 pg/mL
Standard Deviation 16.79
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and at 3 months according to the study protocol. However, due to lack of funding and laboratory resources, ELISA-based quantification of leukemia inhibitory factor (LIF) was not performed, and no outcome data were generated. Consequently, no participants were analyzed for this Outcome Measure (0 in each arm), no statistical analyses were conducted, and no future analyses are planned for this Outcome Measure.
• determination of blood leukemia inhibitory factor (LIF) concentration using ELISA Kit (nanograms per millilitre (ng/mL));
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of interleukins concentrations: IL-1β (interleukin-1beta), using ELISA Kit (picograms per millilitre (pg/mL));
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Blood Interleukins Profile
|
46.52 pg/mL
Standard Deviation 164.81
|
104.61 pg/mL
Standard Deviation 164.60
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: One participant was excluded from the analysis due to an outlier value that affected the normality of the distribution.
• determination of blood cortisol concentration using ELISA Kit (nanograms per millilitre (ng/mL)) - Instead of cortisol, IL-10 levels were analyzed as a marker of anti-inflammatory response \[pg/mL\].
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Quantitive Change in Chronic Stress Biomarker in Blood Samples - Cortisol
|
66.17 pg/mL
Standard Deviation 92.87
|
24.95 pg/mL
Standard Deviation 62.83
|
PRIMARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, c-reactive protein levels were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints and limited time frame. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of C-reactive protein (CRP) concentration using ELISA Kit (picograms per millilitre (pg/mL));
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 months• determination of methods of active coping with stress using the Inventory for Measuring Coping with Stress (Mini-COPE); It is designed to establish how a study participant behaves when experiences particular events; The scale: 0 = "I hardly ever do this", 1 = "I rarely do this", 2 = "I do this often", 3 = "I almost always do this"; \[0-18\] - higher scores mean better outcome
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Coping With Stress Questionnaire
|
-1 score on a scale
Standard Deviation 2.1
|
-0.8 score on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline and 3 months• assessment of the level of fatigue using the Fatigue Assessment Scale (FAS); the statements of the questionnaire relate to the feeling of well-being; The scale: 1. Never (0 points), 2. Sometimes (once a month or less) (1 point), 3. Regularly (several times a month) (2 points), 4. Often (weekly)(3 points) and 5. Always (everyday) (4 points); \[0-32\] - higher score means worse outcome
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Fatigue Questionnaire
|
-6.2 score on a scale
Standard Deviation 4.92
|
-2.8 score on a scale
Standard Deviation 5.51
|
SECONDARY outcome
Timeframe: Baseline and 3 months• assessment of gastrointestinal pain using the Rome IV Questionnaire for adults (selected questions on irritable bowel syndrome, constipation and diarrhea); the statements of the questionnaire relate to frequency and intensity of disorders; \[0-10\] - higher scores mean worse outcome;
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=11 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Gastrointestinal Disorders Questionnaire
|
-0.2 score on a scale
Standard Deviation 0.75
|
-0.55 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline and 3 months• assessment of the sleep quality level using Pittsburgh Sleep Quality Questionnaire (PSQI); the statements of the questionnaire relate to frequency of sleep disorders; \[0-3\] - higher scores mean worse outcome;
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Sleep Quality Questionnaire
|
-0.4 score on a scale
Standard Deviation 0.8
|
0.48 score on a scale
Standard Deviation 0.66
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Participants reported maintaining their habitual diet composition and physical activity throughout the study period, therefore, meaningful changes in BMI were not expected. Within the limited project budget and time frame, BMI was not prioritized for results reporting, BMI change was not derived or tabulated, and no analytical dataset was generated for this outcome. 0 participants were analyzed (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of body weight and composition using the electrical bioimpedance method;
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Body composition measurements (fat mass, fat-free mass as percent of total body mass) were collected according to the study protocol, with participants instructed to maintain their habitual diet and lifestyle. However, outcome data for the prespecified body composition change were not derived or tabulated, and no dataset was generated (limited project budget and time frame). Therefore, no participants were analyzed, no statistical analyses were conducted, and no future analyses are planned.
• assessment of bone, fat and fat-free mass using the electrical bioimpedance method;
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Dietary composition was assessed at baseline using food diaries. Participants were instructed to maintain their habitual diet and lifestyle throughout the study period. However, changes in dietary composition over time were not statistically analyzed, and no longitudinal outcome dataset was generated (limited project budget and time frame). Therefore, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• assessment of protein, fat, carbohydrates and fibre intake using food diaries (grams);
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 months• mechanical stimuli pain threshold assessment using an algometer. Mechanical pressure pain threshold was assessed on the thumb flexor muscle using a pressure algometer. The probe was applied perpendicularly with gradually increasing pressure until the participant indicated the first painful sensation. Three consecutive measurements were performed, and the mean value in Newtons was recorded as the outcome.
Outcome measures
| Measure |
Probiotic Treatment Group (PRO)
n=5 Participants
Daily supplementation with a probiotic capsule containing Lactobacillus helveticus R0052 and Bifidobacterium longum R0175 (Sanprobi Stress), taken once daily for 12 weeks.
|
Placebo Group (PLA)
n=10 Participants
Daily supplementation with a placebo capsule containing starch, identical in appearance to the probiotic capsule, taken once daily for 12 weeks.
|
|---|---|---|
|
Pain Threshold Test (Newtons)
|
-0.93 Newtons
Standard Deviation 5.12
|
-3.9 Newtons
Standard Deviation 10.20
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, red blood cell counts were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of red blood cell counts using flow cytometry (trillion cells per Litre);
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, changes in white blood cell counts were not measured, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of white blood cells counts using flow cytometry (billion cells per Litre);
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, hemoglobin levels were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of hemoglobin level using flow cytometry (grams per Litre);
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, hematocrit levels were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of hematocrit using flow cytometry (percentage of red blood cells in blood);
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and 3 monthsPopulation: Blood samples were collected at baseline and after the intervention from participants who met all inclusion criteria. However, platelet counts were not quantified, and no analyzable outcome data were generated for this measure due to budgetary constraints. Consequently, no participants were analyzed for this outcome (0 in each arm), no statistical analyses were conducted, and no future analyses are planned.
• determination of platelets counts using flow cytometry (billions per Litre)
Outcome measures
Outcome data not reported
Adverse Events
Probiotic Treatment Group (PRO)
Placebo Group (PLA)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place