The NaBu Effect on Menstruation in Women

Official title

The Effect of Sodium Butyrate on Menstrual Symptoms in Women

Overview

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.

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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Northwestern University - Northwestern Medicine, Lavin Family Pavilion — Chicago

Publications

• Tarnowski W, Borycka-Kiciak K, Kiciak A, et al.. Outcome of treatment with butyric acid In irritable bowel syndrome-preliminary report. Gastroenterol Prakt 2013; 1: 43-8
• Banasiewicz T, Krokowicz L, Stojcev Z, Kaczmarek BF, Kaczmarek E, Maik J, Marciniak R, Krokowicz P, Walkowiak J, Drews M. Microencapsulated sodium butyrate reduces the frequency of abdominal pain in patients with irritable bowel syndrome. Colorectal Dis. 2013 Feb;15(2):204-9. doi: 10.1111/j.1463-1318.2012.03152.x. PMID 22738315
• Banasiewicz T, Kaczmarek E, Maik J, et al. Quality of life and the clinical symptoms at the patients with irritable bowel syndrome treated complementary with protected sodium butyrate. Gastroenterol Prakt. 2011;5:45-53.
• Deb S, Zhou J, Amin SA, Imir AG, Yilmaz MB, Lin Z, Bulun SE. 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. J Biol Chem. 2006 Feb 3;281(5):2585-97. doi: 10.1074/jbc.M508498200. Epub 2005 Nov 21. PMID 16303757
• Zhou J, Gao S, Chen J, Zhao R, Yang X. Maternal sodium butyrate supplement elevates the lipolysis in adipose tissue and leads to lipid accumulation in offspring liver of weaning-age rats. Lipids Health Dis. 2016 Jul 22;15(1):119. doi: 10.1186/s12944-016-0289-1. PMID 27449927
• Borycka-Kiciak K, Banasiewicz T, Rydzewska G. Butyric acid - a well-known molecule revisited. Prz Gastroenterol. 2017;12(2):83-89. doi: 10.5114/pg.2017.68342. Epub 2017 Jun 13. PMID 28702095
• Zaleski A, Banaszkiewicz A, Walkowiak J. Butyric acid in irritable bowel syndrome. Prz Gastroenterol. 2013;8(6):350-3. doi: 10.5114/pg.2013.39917. Epub 2013 Dec 30. PMID 24868283
• Simpson ER, Clyne C, Rubin G, Boon WC, Robertson K, Britt K, Speed C, Jones M. Aromatase--a brief overview. Annu Rev Physiol. 2002;64:93-127. doi: 10.1146/annurev.physiol.64.081601.142703. PMID 11826265

Identifiers

NCT: NCT06653426 · STU00220694

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗