NCT06653426 · Magdy Milad, MD
The NaBu Effect on Menstruation in Women
What this study is about
The purpose of this study is to evaluate the effect of once-daily Sodium butyrate (NaBu) on menstrual symptoms in women. The investigators posit that the use of NaBu will reduce menstrual symptoms after taking NaBu for 12 weeks.
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The purpose of this study is to evaluate the effect of once-daily Sodium butyrate (NaBu) on menstrual symptoms in women. The investigators posit that the use of NaBu will reduce menstrual symptoms after taking NaBu for 12 weeks.
Interventions
DIETARY_SUPPLEMENT
Sodium Butyrate (NaBu)
Participants will self-administer Sodium Butyrate (NaBu) daily for 12 weeks. The study aims to evaluate the effect of NaBu on menstrual symptoms by comparing symptom severity before and during the intervention. Participants will maintain an electronic diary (eDiary) to record their daily symptom severity, which will be used to assess changes over time. Regular follow-ups will be conducted to monitor progress and address any side effects or concerns.
Primary outcome measures
Change in Average Menstrual Symptom Scores
Time frame: Baseline period (one menstrual cycle before starting NaBu) and the 12-week treatment period.
The primary outcome measure is the change in average menstrual symptom scores from baseline to the average scores during the 12-week timeframe of taking daily Sodium butyrate (NaBu). Participants will rate their symptoms daily during their menstrual period on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms (e.g., intolerable pain). The average symptom scores during the 12-week treatment period will be compared to the average baseline score to assess the effectiveness of NaBu in reducing menstrual symptoms. Higher scores indicate worse outcomes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 29, 2026 · Source of record for eligibility and locations