Randomized Clinical Trial to Evaluate the Effect of Probiotic Intake on Androgenic Alopecia
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Study Population
2.3. Randomization, Blinding, Intervention, and Compliance
2.4. Outcomes Measurements
2.4.1. Measurement of the Increase in the Number of Hairs per Square Centimeter
2.4.2. Demographic Data and Anthropometry
2.4.3. Comparative Manual Trichograms
2.4.4. Measurement of Scalp Sebum
2.4.5. Comparative Scalp Photographs
2.4.6. Gut Microbial Analysis
2.4.7. Safety of the Investigational Products
2.5. Data-Quality Assurance
2.6. Sample Size
2.7. Statistical Analysis
3. Results
3.1. Capillary Analysis
3.2. Taxonomic Analysis
3.2.1. Alpha Diversity
3.2.2. Beta Diversity
3.2.3. Microbial Communities
3.3. Adverse Events (AEs)
4. Discussion
5. Conclusions
6. Patents
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Abbreviations
References
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Variable | Probiotic | Placebo | p-Value | |
---|---|---|---|---|
Hair count | Baseline | 159 ± 56.1 | 167 ± 50.2 | |
Week 16 | 163 ± 66.8 | 175 ± 61.7 | 0.3638 | |
p-value | 0.5647 | 0.1423 | ||
Hair density/cm2 | Baseline | 174 ± 58.3 | 184 ± 55.6 | |
Week 16 | 178 ± 69.6 | 192 ± 69.3 | 0.5884 | |
p-value | 0.9509 | 0.4033 | ||
Number of telogen hairs | Baseline | 34.3 ± 38.1 | 34.5 ± 30.4 | |
Week 16 | 32.1± 26.9 | 33.1 ± 27.85 | 0.3638 | |
p-value | 0.0314 | 0.3638 | ||
Telogen hair density/cm2 | Baseline | 35.5 ± 29.7 | 36.7 ± 30.8 | |
Week 16 | 35.1 ± 39.2 | 38.1 ± 33.7 | 0.6693 | |
p-value | 0.2170 | 0.5238 | ||
Number of anagen hairs | Baseline | 83.8 ± 29.6 | 87.9 ± 30.5 | |
Week 16 | 82.4 ± 30.6 | 90.8 ± 32 | 0.4177 | |
p-value | 0.7842 | 0.3806 | ||
Anagen hair density/cm2 | Baseline | 92.8 ± 32.8 | 97.3 ± 33.8 | |
Week 16 | 91.3 ± 33.9 | 99.4 ± 33.8 | 0.5146 | |
p-value | 0.7769 | 0.5262 |
Variable | Probiotic | Placebo | p-Value |
---|---|---|---|
Average length (mm) | |||
Baseline | 1.64 ± 0.313 | 1.62 ± 0.331 | 0.3185 |
Week 16 | 2.81 ± 8.82 | 1.63 ± 0.275 | |
p-value * | 0.1593 | 1.000 | |
Average thickness (mm) | |||
Baseline | 0.0694 ± 0.0195 | 0.0676 ± 0.0187 | |
Week 16 | 0.0690 ± 0.0179 | 0.0660 ± 0.01833 | 0.0662 |
p-value * | 0.6842 | 0.0301 |
Variable | Probiotic | Placebo | p-Value | Probiotic (n = 33) | Placebo (n = 34) | p-Value |
---|---|---|---|---|---|---|
Participants aged 37.5 years or younger | Participants over 37.5 years of age | |||||
Hair count | ||||||
Baseline | 153 ± 58.7 | 171 ± 59.0 | 0.0772 | 164 ± 53.9 | 162 ± 40.2 | |
Week 16 | 146 ± 55.5 | 184 ± 75.6 | 180 ± 73.1 | 167 ± 43.3 | 0.3077 | |
p-value * | 0.3123 | 0.1275 | 0.0469 | 0.5664 | ||
Hair density/cm2 | ||||||
Baseline | 165 ± 56.6 | 189 ± 65.3 | 182 ± 59.7 | 179 ± 44.5 | ||
Week 16 | 157 ± 47.9 | 201 ± 85.0 | 0.0659 | 199 ± 81.0 | 183 ± 48.6 | 0.2591 |
p-value * | 0.2430 | 0.1387 | 0.0495 | 0.6941 |
Variables | Probiotic | Placebo | p-Value | Probiotic | Placebo | p-Value |
---|---|---|---|---|---|---|
Participants aged 37.5 years or younger | Participants over 37.5 years of age | |||||
Number of anagen hairs | ||||||
Baseline | 82.1 ± 31.8 | 90.7 ± 34.5 | 0.0772 | 85.5 ± 27.5 | 85.2 ± 26.3 | |
Week 16 | 74.8 ± 27.9 | 94.8 ± 37.2 | 89.8 ± 31.7 | 86.6 ± 25.5 | 0.4521 | |
p-value * | 0.1819 | 0.2281 | 0.2985 | 0.975 | ||
Number of telogen hairs | ||||||
Baseline | 28.1 ± 24.8 | 29.1± 22.4 | 36.2 ± 28.6 | 37.1 ± 32.1 | ||
Week 16 | 22.9 ± 15.4 | 36.9 ± 39.5 | 0.0693 | 45.3 ± 49.4 | 31.9 ± 17.2 | 0.0987 |
p-value * | 0.2605 | 0.1427 | 0.0521 | 0.6778 | ||
Density of anagen hairs/cm2 | ||||||
Baseline | 90.9 ± 35.2 | 100 ± 38.2 | 94.7 ± 30.5 | 94.4 ± 29.1 | ||
Week 16 | 82.8 ± 30.9 | 103 ± 38.5 | 0.1041 | 99.4 ± 35.1 | 95.9 ± 28.2 | 0.4509 |
p-value * | 0.1525 | 0.3741 | 0.2994 | 0.9713 | ||
Telogen hair density/cm2 | ||||||
Baseline | 31.1 ± 27.5 | 32.2 ± 24.8 | 40.1 ± 31.7 | 41.0 ± 31.7 | ||
Week 16 | 25.0 ± 16.2 | 40.8 ± 43.7 | 0.0669 | 44.9 ± 51.1 | 35.4 ± 19.0 | 0.3174 |
p-value * | 0.2456 | 0.1463 | 0.3393 | 0.6416 | ||
Mean length (mm) | ||||||
Baseline | 1.73 ± 0.265 | 1.70 ± 0.290 | 1.56 ± 0.340 | 1.55 ± 0.355 | ||
Week 16 | 1.75 ± 0.220 | 1.63 ± 0.286 | 0.0871 | 3.84 ± 12.4 | 1.63 ± 0.268 | 0.3532 |
p-value * | 0.4035 | 0.1097 | 0.1733 | 0.966 |
Variables | Probiotic | Placebo | p-Value | Probiotic | Placebo | p-Value |
---|---|---|---|---|---|---|
Participants aged 37.5 years or younger | Participants over 37.5 years of age | |||||
Number of terminal hairs | ||||||
Baseline | 86.6 ± 32.9 | 101 ± 41.1 | 90.0 ± 36.1 | 83.7 ± 34.2 | ||
Week 16 | 76.6 ± 30.4 | 102 ± 46.3 | 0.1088 | 98.1 ± 39.3 | 87.6 ± 28.8 | 0.255 |
p-value * | 0.1011 | 0.511 | 0.0641 | 0.8081 | ||
Number of vellus hairs | ||||||
Baseline | 23.6 ± 26.8 | 19.1± 14.2 | 31.7 ± 27.3 | 38.6 ± 41.9 | ||
Week 16 | 19.2 ± 12.3 | 29.0 ± 30.8 | 0.0338 | 36.6 ± 41.2 | 30.9 ± 24.8 | 0.2683 |
p-value * | 0.3746 | 0.0314 | 0.5384 | 0.3413 | ||
Density of terminal hairs/cm2 | ||||||
Baseline | 95.9 ± 36.5 | 109 ± 48.7 | 99.6 ± 40.0 | 92.7 ± 37.8 | ||
Week 16 | 84.9 ± 33.7 | 113 ± 51.2 | 0.0644 | 109 ± 43.2 | 97.0 ± 31.9 | 0.2446 |
p-value * | 0.1064 | 0.2989 | 0.0593 | 0.808 | ||
Density of vellus hairs/cm2 | ||||||
Baseline | 26.2 ± 29.7 | 21.2 ± 15.8 | 35.1 ± 30.2 | 42.7 ± 46.3 | ||
Week 16 | 23.0 ± 19.6 | 32.4 ± 34.3 | 0.0275 | 40.5 ± 45.7 | 34.2 ± 27.5 | 0.2679 |
p-value * | 0.4861 | 0.0143 | 0.5389 | 0.3403 | ||
Mean thickness (mm) | ||||||
Baseline | 0.0726 ± 0.0192 | 0.0739 ± 0.0189 | 0.0661 ± 0.0196 | 0.0614 ± 0.0165 | ||
Week 16 | 0.0741 ± 0.0182 | 0.0670 ± 0.0154 | 0.0492 | 0.0641 ± 0.0165 | 0.0649 ± 0.211 | 0.3757 |
p-value * | 0.7278 | 0.0149 | 0.6819 | 0.3989 |
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García-Navarro, A.; Vasallo-Morillas, M.I.; Navarro-Belmonte, R.; Vilanova, C.; Torrent, D.; Kilasoniya, A.; Moles-Ugeda, I.; Gallego-Herrera, E.; Ramírez-Boscá, A. Randomized Clinical Trial to Evaluate the Effect of Probiotic Intake on Androgenic Alopecia. Nutrients 2024, 16, 2900. https://doi.org/10.3390/nu16172900
García-Navarro A, Vasallo-Morillas MI, Navarro-Belmonte R, Vilanova C, Torrent D, Kilasoniya A, Moles-Ugeda I, Gallego-Herrera E, Ramírez-Boscá A. Randomized Clinical Trial to Evaluate the Effect of Probiotic Intake on Androgenic Alopecia. Nutrients. 2024; 16(17):2900. https://doi.org/10.3390/nu16172900
Chicago/Turabian StyleGarcía-Navarro, Alejandro, María Isabel Vasallo-Morillas, Roge Navarro-Belmonte, Cristina Vilanova, Daniel Torrent, Alina Kilasoniya, Isabel Moles-Ugeda, Estefanía Gallego-Herrera, and Ana Ramírez-Boscá. 2024. "Randomized Clinical Trial to Evaluate the Effect of Probiotic Intake on Androgenic Alopecia" Nutrients 16, no. 17: 2900. https://doi.org/10.3390/nu16172900