Recruiting

Fiber-Based Supplement

Sponsor:

LOAM Science

Code:

NCT07875062

Conditions

Endometriosis

Microbiome Dysbiosis

Gastrointestinal Symptoms

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Fiber

Placebo

Study Details

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.

Conditions

Endometriosis

Microbiome Dysbiosis

Gastrointestinal Symptoms

Study ID

NCT07875062

Start date

Oct, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fiber Supplement

Fiber supplement providing 20 grams/day of dietary fiber. Taken as a scoop of powder added to a drink twice daily.

placebo comparator: Placebo Control

Placebo control. Taken as a scoop of powder added to a drink twice daily.

Interventions

Fiber

Dietary fiber blend containing six prebiotic fibers.

Placebo

Placebo control

Primary outcome measure

  • Incidence and severity of GI adverse events (AEs) and discontinuations. [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Bryce Jarman, PhD

323-325-1327bryce@loamscience.com

Locations

Alethios

Recruiting

San Francisco, California, United States, 94109

Contacts

Zeenia Framroze

(650) 206-8006zeenia@alethios.com

More Information

Sponsor

LOAM Science

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Keywords

  • Endometriosis
  • Fiber
  • Prebiotic
  • Gut Microbiome
  • Vaginal Microbiome
  • Gastrointestinal

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by LOAM Science on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.