Endometriosis, Microbiome Dysbiosis, Gastrointestinal Symptoms
Conditions
Keywords
Endometriosis, Fiber, Prebiotic, Gut Microbiome, Vaginal Microbiome, Gastrointestinal
Brief 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.
Interventions
DIETARY_SUPPLEMENTFiber
Dietary fiber blend containing six prebiotic fibers.
DIETARY_SUPPLEMENTPlacebo
Placebo control
Sponsors
LOAM Science
Alethios, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Confirmed diagnosis of endometriosis (by imaging, laparoscopy, or physician clinical assessment). * Enriched gastrointestinal phenotype: self-reported gastrointestinal symptoms on at least 3 days per week for the preceding 3 months, including at least one of bloating, constipation, or abdominal discomfort * Predominantly Bristol Stool Scale Type 1-3 (constipation-predominant), or self-reported bloating as a dominant symptom. * Stable hormonal status: either no hormonal therapy, or stable hormonal therapy (combined oral contraceptive, progestin, or GnRH analogue) for at least 3 months with no planned change during the study. * Estimated habitual dietary fiber intake below 25 g/day based * Willingness to share menstrual cycle data. * Willing to maintain stable diet, physical activity, and medication regimens throughout the study. * Able to provide electronic informed consent and to comply with stool and vaginal self-sampling procedures. * Ownership and consistent use of a home body-weight scale for the duration of the study, to support the standardized at-home morning weighing protocol.
Exclusion criteria
* Inflammatory bowel disease (Crohn's disease, ulcerative colitis), celiac disease, or other organic gastrointestinal disease. * Severe irritable bowel syndrome (IBS) requiring active pharmacological management. Mild-to-moderate overlap is permitted as part of the enrichment strategy. * Antibiotic use within 8 weeks prior to baseline or anticipated during the study. * Probiotic, prebiotic, or fiber supplement use within 4 weeks prior to baseline (washout required). * Major gastrointestinal surgery, excluding appendectomy or cholecystectomy more than 6 months prior, and excluding surgical intervention for endometriosis. * Current pregnancy, breastfeeding, or plans to conceive during the study. * Severe constipation requiring regular prescription laxatives. * Significant renal, hepatic, cardiac, or endocrine disease. * Active malignancy. * Known allergy or intolerance to any LOAM fiber component. * Significant dietary change or weight-loss intervention within the preceding 3 months. * Use of medications known to significantly alter gut motility or the microbiome (for example, recent metformin initiation, regular opioid use, or chronic proton-pump inhibitor use), per investigator judgment. * Any surgical intervention for endometriosis (including laparoscopy, laparotomy, or endometrioma excision) within the 6 months prior to screening, as post-surgical physiological changes may confound symptom and biomarker assessments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of GI adverse events (AEs) and discontinuations. | An adverse event questionnaire will be administered at baseline and at Week 4, Week 6, Week 8, and Week 12 of supplementation. Adverse events will also be collected ad hoc throughout the study period via a reporting form. | To evaluate the safety and tolerability of the fiber blend. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in a custom gut health questionnaire | From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12). | A custom gut health questionnaire using a 5-point Likert Scale (1-5) where 1 is no symptoms and 5 is the worst symptoms designed to evaluate GI symptoms relevant to endometriosis. |
| DASS-21 | From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12). | Self-reported mental health tool to evaluate depression, anxiety, and stress that uses a 4-point Likert Scale (0-3) where 0 is not applicable and 3 is highly applicable. |
| Pelvic discomfort duration over 24 hours | From baseline sample collection through the end of supplementation (Daily). | Evaluation of pelvic discomfort associated with endometriosis over the previous 24 hours using a 0-24 scale, where 0 is no hours of pelvic discomfort and 24 is pelvic discomfort for the entire duration of the last 24 hours. |
| Pelvic discomfort severity | From baseline sample collection through the end of supplementation (daily). | Pelvic discomfort severity assessed using a 10 point numerical rating scale (0-10) with zero being no discomfort and ten being the highest level of discomfort. |
| Body Weight | From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12). | Performed at home using a scale |
Countries
United States
Contacts
CONTACTBryce Jarman, PhD
PRINCIPAL_INVESTIGATORBryce Jarman, PhD
LOAM Science
Outcome results
None listed