Study on Daily Sodium Butyrate Tablets to Reduce Menstrual Symptoms in Women
Led by Magdy Milad, MD · Updated on 2026-04-29
15
Participants Needed
1
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to study the effects of Sodium Butyrate NaBu, a dietary supplement, on menstrual symptoms in women. The study focuses on common symptoms such as abdominal or pelvic cramping, lower back pain, bloating, mood swings, and irritability, which are thought to be linked to estrogen production in certain cells. Researchers believe that NaBu may reduce these symptoms by inhibiting a key enzyme involved in estrogen synthesis.
Participants will take 2.4 grams of Sodium Butyrate daily in tablet form for 12 weeks. They will self-administer the supplement and record their daily symptom severity using an electronic diary. The study compares symptom scores recorded before starting NaBu with those during the 12-week treatment to evaluate changes.
During the study, participants will have regular follow-ups to monitor progress and any side effects. Researchers will measure changes in average menstrual symptom scores between the baseline period one menstrual cycle before starting NaBu and the treatment period. The total participation involves daily symptom tracking and supplement use over 12 weeks.
CONDITIONS
Brief Title
The NaBu Effect on Menstruation in Women
Research Team
J
juan A avitia, MS
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Sodium butyrate (NaBu)
Usual care (e.g., non-prescription analgesics, lifestyle measures)
What it is
A dietary supplement regimen where participants take sodium butyrate (NaBu) once daily for 12 weeks.
Current practice for menstrual symptoms in adults commonly includes over-the-counter pain relievers such as nonsteroidal anti-inflammatory drugs (NSAIDs), use of heat, exercise, and other self-care strategies.
Role in trial
Investigational therapy being evaluated for its effect on symptom severity among women experiencing menstrual symptoms.
Represents usual symptom management outside of clinical trials for adults with menstrual symptoms.
Primary use
Studied for potential to improve menstrual symptoms, as measured by changes in patient-reported symptom intensity scores.
To lessen menstrual discomfort and improve quality of life using established non-prescription options.
How it is given or performed
Participants self-administer sodium butyrate by mouth daily and record symptom severity using an electronic diary.
Non-prescription medications (e.g., NSAIDs) are taken as needed at home. Lifestyle changes or physical measures such as heat or exercise are self-initiated.
Evidence status
There are currently no published trial results for sodium butyrate in menstrual symptoms; efficacy in this setting remains investigational.
Over-the-counter pain relievers and lifestyle measures are widely recommended and supported by clinical practice as effective for many individuals with menstrual discomfort.
Important limitations
Not yet studied for menstrual symptoms; possible gastrointestinal intolerance or unknown side effects in this population. Small sample size and lack of published results limit certainty.
Non-prescription pain relievers and self-care may not fully control symptoms for everyone. Some individuals may experience adverse effects (e.g., gastrointestinal upset with NSAIDs).
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
18 years or older
Currently menstruating regularly or irregularly
Experiencing menstrual symptoms with an average baseline severity score of at least 3 out of 10 for at least one symptom during the initial rating period
You will not qualify if you...
Pregnant or breastfeeding, or planning to become pregnant
History of bloating or sensitive gut requiring low fiber intake
Known lactose intolerance, FODMAP intolerance, or small intestinal bacterial overgrowth (SIBO)
Requires daily antacids during the study
Known or suspected chronic hypertension
Post-menopausal status
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 12 weeks
Participants self-administer Sodium Butyrate (NaBu) daily for 12 weeks to evaluate its effect on menstrual symptoms. They maintain an electronic diary (eDiary) to record daily symptom severity during this period.
Daily self-administration and symptom recording via eDiary
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
A novel role of sodium butyrate in the regulation of cancer-associated aromatase promoters I.3 and II by disrupting a transcriptional complex in breast adipose fibroblasts.