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Women’s Health Clinical Trials

Scientific Background

Life expectancy for women is higher than for men, and this is referred as women’s mortality advantage. However, the extra years are not healthy years, as on average the 10 last years are spent in ill health. The rates of mental ill health are increasing throughout Developed countries and across all ages, coupled with the fact that cardiovascular diseases continue to comprise a major part of the overall disease burden for women (WHO, 2016).   See our Cardiovascular health and Cognitive health  pages about these topics.

Looking at women’s health and illness at different life stages allows the identification of specific interventions that can minimize risks and maximize protective factors and assets.  Key areas for action to reduce health inequities for women throughout the life-course are related to women’s sexual and reproductive health (WHO, 2016).

There is growing scientific research pointing out the woman’s vaginal microbiome as a key player for female reproductive health and the health of their offspring, not only influencing health and dysbiosis, but also potentially in successful fertilization and healthy pregnancies.

Large cohorts with non-pregnant healthy women have shown differences on the ‘normal’ microbiome of the vagina, related to age, race, geographical location and nutrition, however it predominantly includes a variety of Lactobacillus species, which promote a healthy, supportive environment for the embryo in the pre and peri-conceptual period.

Managing bladder and vaginal infections are generally based on antibiotic treatments and they are frequently related to recurrence, and chronic infections. This increases the necessity for new and more effective treatment or prevention options. It is possible to foresee clinical advantages for the use of biotherapeutic agents (prebiotics and/or probiotics) for treating these infections. Studies demonstrate that probiotics can be taken in association with antibiotics and antifungal agents, used to eradicate infections. So, probiotics and prebiotics can be a relevant auxiliary to pharmaceutical and other approaches used in the care of feminine health.

Pre- and probiotic beneficial effects can be delivered topically or systemically. In general, both approaches have the potential to optimize, maintain and restore the ecology of the vaginal ecosystem.

Probiotic use has indications that include reduction in vaginal and urinary tract infections, and also reduction of preterm birth, reduction of gestational diabetes mellitus and reduction of postpartum depression.

Prebiotics, as specific carbohydrates, can provide a therapeutic approach for controlling infections by stimulating the growth of the indigenous lactobacilli but inhibiting the growth and adhesion of pathogens to the vaginal epithelial cells.

Interventional clinical trials in Women's health need to be of a sufficient size and duration to understand the functional benefits of the potential pre- and probiotics. These trials should include mechanistic components focused on the biomarkers of vaginal health to link biological changes to any functional benefits that might be observed.

What Atlantia offer

As a spin out of the APC Microbiome Ireland, Atlantia Food Clinical Trials has extensive experience in conducting trials across the health area related to women's health. This includes cognition, physical performance, osteoarthritis, cardiovascular health, vaginal and reproductive health. We provide our clients with state-of-the-art microbiome research through all stages of the clinical trial process from design and conduct of the trial right through to the final report.

We conduct extensive microbiome sampling and analysis including 16S and shotgun sequencing, metabolomics and bioinformatics.

We have conducted trials on a variety of investigational food products (IP), ranging from probiotics, prebiotics, fibers and a range of other substrates, including botanical extracts, minerals, vitamins and peptides.

We have a large database of healthy subjects striated across age, and also a considerable patient database: UTI, vaginosis and vaginal dysbiosis (thrush, dryness and candidiasis).

Our expert research team will work with sponsor(s) to design and conduct a study most suitable for their IP, agreeing and applying the most suitable diagnostics. We can statistically power your study to ensure that your objectives are achieved and reported in accordance with EFSA  and FDA guidelines.

 

Measurements & Indications

Woman Health Analysis (SUBJECTIVE)
Physical Activity: International Physical Activity Questionnaire (IPAQ)
Well being: WHO 5 well being index, Quality of life using Assessment of Quality of Life (AQoL), 36-item short form (SF-36)
Gastrointestinal Health: Gastrointestinal symptom rating scale (GSRS)
Anxiety & Sleep Quality: Hamilton Anxiety Rating Scale (HAM-A); /td>
Dietary Analysis: FFQ, 24 hour recall, 3 day diary
Woman Health Analysis (OBJECTIVE)
Cardiovascular Health: Blood Pressure (BP); Ambulatory BP; Endothelial function e.g. flow-mediated dilation (FMD)
Gastrointestinal Health: GI transit; bowel function; microbiome diversity
Physical Activity & performance: aerobic capacity/VO2 max; muscle max/strength
Body composition measurements e.g. % lean muscle, bone density, using DEXA scan; Biometric & Anthropometric Measurements: resting heart rate, weight, muscle circumference
Vaginal infections (VI) follow up: Amsel's criteria and Nugent scoring system used as diagnostic method and primary outcomes evaluation, reduction in episodes of VI (compared to placebo), Severity of VI symptoms , Duration of VI symptoms, Microbiological profiling (Vaginal Microbiome)
Biological Sample Analysis: inflammatory biomarkers; plasma essential and non-essential amino acids, total protein, albumin, serum and urinary urea; plasma and salivary cortisol, IgA, tryptophan (stress indicators), creatinine; glucose; serum triglyceride; omega-3 fatty acids; oxidative stress measurements

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