Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis

NCT07875062 · ctgov not_yet_recruiting
Enrollment
140
Start
2026-10-01
Completion
2027-09-01
Last updated
2026-10-20
Has results
False

Conditions

EndometriosisMicrobiome DysbiosisGastrointestinal Symptoms

Tagged with

endometriosis

Interventions

Eligibility criteria
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.
License: public-domain-us · commercial use OK · attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine

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