The NaBu Effect on Menstruation in Women
The Effect of Sodium Butyrate on Menstrual Symptoms in Women
Magdy Milad, MD
15 participants
Oct 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria3
- 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 Criteria6
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06653426