Synbiotic HQP08 Supplementation for Hair Loss and Depressive Symptoms: An Open-Label Pilot Study of Clinical Outcomes and Gut Microbiome Changes.

62.5% of participants reported improvement on the Patient Global Impression of Change scale at week 8 following HQP08 synbiotic supplementation.

• 20 out of 32 participants reported PGI-C improvement at the primary endpoint of week 8.
• The study was an open-label, single-arm pilot study with no control group.
• Participants were adults with self-reported hair loss over an 8-week intervention period.
• The trial was registered with the Chinese Clinical Trial Registry (ChiCTR2500112698).

Significant reductions in hair loss severity were observed after 8 weeks of HQP08 supplementation.

• Hair loss severity reduction reached statistical significance at p = 0.0008.
• The 60-second hair count also showed significant reduction (p = 0.0048).
• Both measures reflect within-participant changes in the absence of a control arm.
• The study duration was 8 weeks for the primary and secondary hair-related endpoints.

Significant reductions in depressive symptoms as measured by PHQ-9 scores were observed following HQP08 supplementation.

• PHQ-9 score reductions were statistically significant at p = 0.002.
• PHQ-9 (Patient Health Questionnaire-9) was included as a secondary outcome measure.
• Changes in microbial pathways related to thiamine metabolism, vitamin B12 salvage, and lipopolysaccharide biosynthesis were associated with ΔPHQ-9 (FDR-adjusted p < 0.05).
• These microbial pathway changes were not associated with hair-related endpoints.

Younger age was significantly associated with PGI-C response to HQP08 supplementation.

• The odds ratio per year of age was 0.86 (95% CI: 0.73–0.98, p = 0.037), indicating that younger participants were more likely to report improvement.
• This association was identified through logistic regression analysis of PGI-C responders versus non-responders.
• Age was identified as the only reported significant predictor of treatment response in this analysis.

Metagenomic analysis identified engraftment of B. longum HK003-like profiles in a subset of participants at week 12.

• Gut microbiome composition was assessed as part of the secondary outcomes.
• Engraftment was not observed in all participants, only in a subset.
• The follow-up metagenomic analysis was conducted at week 12, four weeks after the end of the 8-week intervention.
• The synbiotic HQP08 contains Bifidobacterium longum HK003, which had previously been shown to reverse alopecia-like phenotypes in mice.

No serious adverse events occurred during the study, indicating HQP08 was well tolerated.

• Safety was listed as a secondary outcome of the study.
• The open-label, single-arm design included 32 adult participants.
• The intervention period was 8 weeks.
• The authors describe HQP08 as 'well tolerated' in their conclusions.

The study was motivated by prior preclinical evidence showing that Bifidobacterium longum HK003 reverses alopecia-like phenotypes in mice via the gut-skin axis.

• Gut microbiota dysregulation has been implicated in hair loss via the gut-skin axis.
• Human interventional data on this mechanism were described as limited at the time of the study.
• HQP08 is a synbiotic (containing both probiotic and prebiotic components) that includes B. longum HK003.
• This study is described as a 'first-in-human pilot study' of this synbiotic for hair loss.