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Improvement of sperm quality through an indication-specific probiotic – An exploratory pilot study

Improvement of sperm quality through an indication-specific probiotic – An exploratory pilot study - ProSam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037272
Enrollment
30
Registered
2025-06-26
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sperm quality

Interventions

Group 1: 30 participants take a multi-species probiotic once daily for 120 days.

Sponsors

Institut AllergoSan Deutschland (privat) GmbH
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patients with diagnosed pathospermia The ability to begin taking the study medication promptly after inclusion in the study Signed informed consent form

Exclusion criteria

Exclusion criteria: Use of antibiotics within the last 4 weeks Use of probiotics within the last 4 weeks Intake of explicitly fertility-enhancing supplements within the last 4 weeks Regular or repeated use of medications known to impair spermatogenesis (according to the package insert) Severe impairment of semen quality: Oligo-Astheno-Teratozoospermia (OAT) grade III, pronounced parvisemia with an ejaculate volume < 1 ml Diagnosed gastrointestinal diseases (e.g., Crohn’s disease, ulcerative colitis) that could impair absorption of the study medication Congenital or acquired conditions (e.g., diabetes mellitus) or malformations (e.g., Klinefelter syndrome) that affect spermatogenesis Immunocompromised individuals Internally diagnosed conditions requiring medical treatment (e.g., cancer, liver dysfunction, severe heart disease) Necessity to take antibiotics during the intervention phase

Design outcomes

Primary

MeasureTime frame
Pathospermia defined by: Volume of ejaculate (in ml), Density – sperm concentration per ml, Motility (in percent): a) progressively motile b) forward motile c) non-progressive d) immotile, Morphology – percentage of normally shaped sperm cells.

Secondary

MeasureTime frame
Change in the seminal microbiome (comparison between T0 and T1), change in hormone production across the three measurement time points: •Total testosteron ng/ml, •Total testosterone ng/ml, • estradiol pg/ml, • Sex hormone-binding globulin nmol/l, • Follicle stimulating hormone mIU/ml, • luteinizing hormone mIU/ml and • Prolactin µg/l • Albumin g/dl

Countries

Germany

Contacts

Public ContactTobias Jäger

Urologische Praxisklinik Essen

jaeger@upk-essen.de+49 201-604262

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026