The NaBu Effect on Menstruation in Women

Magdy Milad, MD

Status: Enrolling

Conditions: Menstrual Symptoms

Treatments: Dietary Supplement: Sodium Butyrate (NaBu)

Study type: Interventional

Funder types: Other

Identifiers

NCT06653426

STU00220694

Details and patient eligibility

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.

Full description

The general symptoms of menstruation include abdominal and/or pelvic cramping, lower back pain, bloating, mood swings, and irritability. The exact etiology of these symptoms is not well described. Many pathologies that lead to dysmenorrhea are associated with estrogen-dependent cells, such as endometrial cells, linking estrogen production at the cellular level with symptoms of menstruation.

Sodium butyrate (NaBu) is a food supplement readily available in the US in stores and online. It has been shown to inhibit aromatase, a key enzyme in the estrogen biosynthesis pathway, through a mechanism specific to endometrial cells. The transcription process of estrogen is regulated by up to 10 different promotors, depending on the tissue (Attar, 2006; Simpson, 2002). Aromatase transcription in ovarian endometrioma-derived cells & extra-ovarian endometrioma-derived cells is mediated by Promotor II (Attar 2006). NaBu works by inhibiting the phosphorylation and binding of Activating Transcription Factor 2 (ATF2) to promotor II (Deb, 2006). Thus, NaBu has the potential to reduce estrogen synthesis via the inhibition of the aromatase pathway in cells that use promotor II and in no other tissues.

In this study, the investigators will evaluate the effect of daily NaBu on the baseline symptoms of menstruation in women.

Enrollment: 15 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Sodium butyrate (NaBu)

Experimental group

Description:

Participants in the study will be administered Sodium Butyrate (NaBu) in tablet form. Each participant will take a dosage of 2.4 grams, which equates to two tablets, once daily. This regimen will be maintained for a duration of 12 weeks. The supplement is self-administered, and participants are required to record their daily symptom severity in an electronic diary (eDiary) throughout the study period. This intervention aims to assess the effectiveness of NaBu in reducing menstrual symptoms by comparing the average symptom scores during the 12-week treatment period to the baseline scores recorded before starting the supplement.

Treatment:

Dietary Supplement: Sodium Butyrate (NaBu)