An interventional study of Fiber and Placebo in Endometriosis, Microbiome Dysbiosis and Gastrointestinal Symptoms, sponsored by LOAM Science. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by LOAM Science · Not applicable, Interventional, and Other
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.
925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.
This study's planned enrollment of 140 is above the median of 65 across 539 interventional studies indexed under Endometriosis.
Browse Endometriosis studies →LOAM Science is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Fiber supplement providing 20 grams/day of dietary fiber. Taken as a scoop of powder added to a drink twice daily.
Dietary Supplement: Fiber
Placebo control. Taken as a scoop of powder added to a drink twice daily.
Dietary Supplement: Placebo
Dietary fiber blend containing six prebiotic fibers.
Placebo control
Incidence and severity of GI adverse events (AEs) and discontinuations.
To evaluate the safety and tolerability of the fiber blend.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline sample collection through the end of supplementation (daily).
Body Weight
Performed at home using a scale
Time frame: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Gut Microbiome Composition
Evaluation of the gut microbiome composition using shotgun metagenomic sequencing.
Time frame: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Gut Microbiome Function
Evaluation of the gut microbiome function using shotgun metagenomic sequencing.
Time frame: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Vaginal Microbiome Composition
Evaluation of the vaginal microbiome composition using shotgun metagenomic sequencing.
Time frame: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Custom endometriosis quality of life survey
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.
Time frame: From baseline sample collection through the end of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Vaginal Microbiome Function
Evaluation of the vaginal microbiome function using shotgun metagenomic sequencing.
Time frame: Three separate samplings, one at baseline, one at six weeks, and one at 12 weeks.
Endometriosis-related Medication Use
Medication use assess by open-ended questionnaire.
Time frame: From enrollment through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Deep dyspareunia
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.
Time frame: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Dysmenorrhea
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.
Time frame: From baseline through the conclusion of supplementation (daily).
Non-menstrual pelvic discomfort
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.
Time frame: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Dyschezia
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.
Time frame: From baseline through the conclusion of supplementation (daily).
Productivity Impairment
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.
Time frame: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Bloating severity and abdominal girth
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.
Time frame: From baseline through the conclusion of supplementation (Baseline, Week 4, Week 6, Week 8, and Week 12).
Plan to share: No — The data is proprietary data.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Dietary Fiber
LOAM Science