Trial Evaluating Nutritional Fiber in Digestive Symptoms of Endometriosis (TEND)
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Bryce Jarman, PhD
- Telefonní číslo: 323-325-1327
- E-mail: bryce@loamscience.com
Studijní místa
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California
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San Francisco, California, Spojené státy, 94109
- Nábor
- Alethios
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Kontakt:
- Zeenia Framroze
- Telefonní číslo: (650) 206-8006
- E-mail: zeenia@alethios.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Fiber Supplement
Fiber supplement providing 20 grams/day of dietary fiber. Taken as a scoop of powder added to a drink twice daily. |
Dietary fiber blend containing six prebiotic fibers. |
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Komparátor placeba: Placebo Control
Placebo control. Taken as a scoop of powder added to a drink twice daily. |
Placebo control |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Incidence and severity of GI adverse events (AEs) and discontinuations.
Časové okno: 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.
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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.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Changes in a custom gut health questionnaire
Časové okno: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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DASS-21
Časové okno: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Pelvic discomfort duration over 24 hours
Časové okno: From baseline sample collection through the end of supplementation (Daily).
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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).
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Pelvic discomfort severity
Časové okno: From baseline sample collection through the end of supplementation (daily).
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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).
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Body Weight
Časové okno: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gut Microbiome Composition
Časové okno: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
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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.
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Gut Microbiome Function
Časové okno: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
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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.
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Vaginal Microbiome Composition
Časové okno: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
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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.
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Custom endometriosis quality of life survey
Časové okno: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Vaginal Microbiome Function
Časové okno: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
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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.
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Endometriosis-related Medication Use
Časové okno: From enrollment through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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Medication use assess by open-ended questionnaire. |
From enrollment through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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Deep dyspareunia
Časové okno: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Dysmenorrhea
Časové okno: From baseline through the conclusion of supplementation (daily).
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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).
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Non-menstrual pelvic discomfort
Časové okno: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Dyschezia
Časové okno: From baseline through the conclusion of supplementation (daily).
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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).
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Productivity Impairment
Časové okno: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Bloating severity and abdominal girth
Časové okno: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
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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).
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Bryce Jarman, PhD, LOAM Science
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- LOA001
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
The data is proprietary data.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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