The NaBu Effect on Menstruation in Women

Not Applicable

Recruiting

• Conditions: Menstrual Symptoms

• Registration Number: NCT06653426
• Lead Sponsor: Magdy Milad, MD

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-15
• Study First Submitted QC: 2024-10-20
• Study First Posted: 2024-10-22
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Average Menstrual Symptom Scores	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.

Trial Locations

Locations (1)

Northwestern University - Northwestern Medicine, Lavin Family Pavilion; 🇺🇸 Chicago, Illinois, United States