Evaluating Sodium Butyrate's Effect on Menstrual Symptoms in Women
The Effect of Sodium Butyrate on Menstrual Symptoms in Women
This study is testing if taking Sodium butyrate every day can help women with painful menstrual symptoms feel better over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06653426 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the impact of daily Sodium butyrate (NaBu) supplementation on menstrual symptoms in women over a 12-week period. The researchers hypothesize that NaBu will alleviate common menstrual symptoms such as cramping, back pain, and mood swings by inhibiting the aromatase enzyme involved in estrogen production. Participants will be women aged 18 and older who experience significant menstrual symptoms. The study will measure changes in symptom severity before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who experience regular or irregular menstruation with moderate to severe menstrual symptoms.
Not a fit: Patients who are pregnant, breastfeeding, or post-menopausal will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary approach to significantly reduce menstrual symptoms for women.
How similar studies have performed: While the specific use of Sodium butyrate for menstrual symptoms is novel, other studies have explored dietary supplements for similar conditions with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older. * Menstruating regularly or irregularly * Experiencing menstrual symptoms with an average baseline symptom score of at least 3 on a scale of 0 to 10 for at least one symptom during the initial pre-study rating period. Exclusion Criteria: * Pregnant or breastfeeding patient, attempting or anticipating pregnancy. * Patient with a history of bloating or a sensitive gut (food intolerance) who needs lower fiber levels. * Patients with known lactose intolerance, other fermentable oligo-, di-, and mono-saccharides, and polyols (FODMAP) intolerances, or small intestinal bacterial overgrowth (SIBO). * Patients who would require taking daily antacids for the duration of the study. * Patients with known or suspected chronic hypertension. * Post-menopausal patients
Where this trial is running
Chicago, Illinois
- Northwestern University - Northwestern Medicine, Lavin Family Pavilion — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Magdy P Milad, MD MS — Northwestern Medicine
- Study coordinator: juan A avitia, MS
- Email: juan.avitia1@nm.org
- Phone: 312-694-6447
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.