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
Tagged with
Interventions
-
Fiber
DIETARY_SUPPLEMENT
Dietary fiber blend containing six prebiotic fibers.
-
Placebo
DIETARY_SUPPLEMENT
Placebo control
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
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine