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Evaluating the Impact of a Multi-Fiber Prebiotic Dietary Supplement (LOAM) in Women With Endometriosis and Co-existing Gastrointestinal Symptoms
Sponsor: LOAM Science
Summary
This study is a double-blind, randomized, placebo-controlled study that evaluates the safety and tolerability of a fiber-based dietary supplement and the mechanistic and structure-function effects of that supplement on the gut and vaginal microbiome, gastrointestinal well-being, and quality-of-life parameters in 140 women with endometriosis and co-existing gastrointestinal symptoms over 12 weeks. The primary objective is to evaluate the safety and tolerability of the supplement, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fibers impact on gastrointestinal symptoms and quality of life through the use of custom questionnaires built for the study population and evaluation of other endometriosis related parameters such as pelvic discomfort. Exploratory objectives focus on the exploration of the gut and vaginal microbiomes, their connection to endometriosis, and how they are impacted by the study product.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Mechanistic Effects of a Multi-Fiber Prebiotic Dietary Supplement (LOAM) on the Gut and Vaginal Microbiome, Gastrointestinal Well-Being, and Quality-of-Life Parameters in Women With Endometriosis and Co-Existing Gastrointestinal Symptoms
Key Details
Gender
FEMALE
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-10
Completion Date
2027-09
Last Updated
2026-10-15
Healthy Volunteers
Yes
Interventions
Fiber
Dietary fiber blend containing six prebiotic fibers.
Placebo
Placebo control