EndometriosisTENDNCT07875062
Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis
A study testing Fiber in people with Endometriosis and Microbiome Dysbiosis, run by LOAM Science at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Microbiome Dysbiosis, Gastrointestinal Symptoms
- What is being tested?
- Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Alethios
San Francisco, California, 94109
Zeenia Framroze, (650) 206-8006, zeenia@alethios.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Mechanistic Effects of a Multi-Fiber Prebiotic Dietary Supplement (LOAM) on the Gut and Vaginal Microbiome, Gastrointestinal Well-Being, and Quality-of-Life Parameters in Women With Endometriosis and Co-Existing Gastrointestinal Symptoms
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.
- Being tested
- Fiber, Placebo
- Keywords
- Endometriosis, Fiber, Prebiotic, Gut Microbiome, Vaginal Microbiome, Gastrointestinal
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FiberDietary supplement
Dietary fiber blend containing six prebiotic fibers.
PlaceboDietary supplement
Placebo control
| Study group | Role | What they receive |
|---|---|---|
| Fiber Supplement | Experimental | Fiber supplement providing 20 grams/day of dietary fiber. Taken as a scoop of powder added to a drink twice daily. Receives: Dietary Supplement: Fiber |
| Placebo Control | Placebo comparator | Placebo control. Taken as a scoop of powder added to a drink twice daily. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of GI adverse events (AEs) and discontinuations.
To evaluate the safety and tolerability of the fiber blend.
Measured: 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.
Secondary outcomes (5)
Changes in a custom gut health questionnaire
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.
Measured: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
DASS-21
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.
Measured: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Pelvic discomfort duration over 24 hours
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.
Measured: From baseline sample collection through the end of supplementation (Daily).
Pelvic discomfort severity
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.
Measured: From baseline sample collection through the end of supplementation (daily).
Body Weight
Performed at home using a scale
Measured: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LOAM Science
- Sponsor type
- University, hospital or other
- Collaborators
- Alethios, Inc.
- Responsible party
- Sponsor
- Investigators
- Bryce Jarman, PhD, Principal investigator, LOAM Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875062
- Sponsor's protocol ID
- LOA001
- Acronym
- TEND
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is proprietary data.