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Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis (TEND)

9 november 2026 bijgewerkt door: LOAM Science

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • San Francisco, California, Verenigde Staten, 94109
        • Werving
        • Alethios
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 45 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Fiber Supplement

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

Dietary fiber blend containing six prebiotic fibers.
Placebo-vergelijker: Placebo Control

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

Placebo control

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence and severity of GI adverse events (AEs) and discontinuations.
Tijdsspanne: 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.

To evaluate the safety and tolerability of the fiber blend.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Changes in a custom gut health questionnaire
Tijdsspanne: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

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.
From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
DASS-21
Tijdsspanne: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

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.
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
Tijdsspanne: From baseline sample collection through the end of supplementation (Daily).

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.
From baseline sample collection through the end of supplementation (Daily).
Pelvic discomfort severity
Tijdsspanne: From baseline sample collection through the end of supplementation (daily).

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.
From baseline sample collection through the end of supplementation (daily).
Body Weight
Tijdsspanne: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Performed at home using a scale
From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gut Microbiome Composition
Tijdsspanne: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.

Evaluation of the gut microbiome composition using shotgun metagenomic sequencing.
Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Gut Microbiome Function
Tijdsspanne: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.

Evaluation of the gut microbiome function using shotgun metagenomic sequencing.
Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Vaginal Microbiome Composition
Tijdsspanne: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.

Evaluation of the vaginal microbiome composition using shotgun metagenomic sequencing.
Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Custom endometriosis quality of life survey
Tijdsspanne: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

A custom survey designed to assess the impact of endometriosis on an individuals quality of life. Questions are scored using a 5-point Likert Scale (1-5) where 1 is no impact on quality of life and 5 is the highest level of impact.
From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Vaginal Microbiome Function
Tijdsspanne: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.

Evaluation of the vaginal microbiome function using shotgun metagenomic sequencing.
Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Endometriosis-related Medication Use
Tijdsspanne: From enrollment through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Medication use assess by open-ended questionnaire.
From enrollment through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Deep dyspareunia
Tijdsspanne: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Deep dyspareunia severity assessed using a 10 point numerical rating scale (0-10) with zero being no discomfort and ten being the highest level of discomfort.
From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Dysmenorrhea
Tijdsspanne: From baseline through the conclusion of supplementation (daily).

Dysmenorrhea severity assessed using a 10 point numerical rating scale (0-10) with zero being no discomfort and ten being the highest level of discomfort.
From baseline through the conclusion of supplementation (daily).
Non-menstrual pelvic discomfort
Tijdsspanne: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Non-menstrual 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.
From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Dyschezia
Tijdsspanne: From baseline through the conclusion of supplementation (daily).

Dyschezia severity assessed using a 10 point numerical rating scale (0-10) with zero being no discomfort and ten being the highest level of discomfort.
From baseline through the conclusion of supplementation (daily).
Productivity Impairment
Tijdsspanne: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Measured using the Work Productivity and Activity Impairment Questionnaire, which includes open ended questions to assess hours missed as well as personal assessments of productivity using a 10 point numerical rating scale (0-10) with zero being no effect and ten being highly impacted.
From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Bloating severity and abdominal girth
Tijdsspanne: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Bloating severity assessed using a 10 point numerical rating scale (0-10) with zero being no bloating and ten being the highest level of bloating and abdominal girth measured by tape measure.
From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

LOAM Science

Medewerkers

Alethios, Inc.

Onderzoekers

  • Hoofdonderzoeker: Bryce Jarman, PhD, LOAM Science

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

20 oktober 2026

Primaire voltooiing (Geschat)

1 juni 2027

Studie voltooiing (Geschat)

1 september 2027

Studieregistratiedata

Eerst ingediend

6 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 oktober 2026

Eerst geplaatst (Werkelijk)

15 oktober 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 november 2026

Laatste update ingediend die voldeed aan QC-criteria

9 november 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LOA001

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

The data is proprietary data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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