Fiber supplement for digestive symptoms in endometriosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled trial tests a fiber-based dietary supplement in 140 women with endometriosis and gastrointestinal symptoms over 12 weeks. The study primarily assesses safety and tolerability by tracking gastrointestinal adverse events and discontinuations. Secondary goals examine effects on gastrointestinal symptoms, quality of life, and pelvic discomfort, with exploratory analyses of gut and vaginal microbiomes and their relation to endometriosis. Participants will provide stool and vaginal samples and complete custom questionnaires relevant to this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Alethios
  San Francisco, California, United States Recruiting

Study contacts

• Principal investigator: Bryce Jarman, PhD — LOAM Science
• Study coordinator: Bryce Jarman, PhD
• Email: bryce@loamscience.com
• Phone: 323-325-1327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.