Viewing Study NCT06653426



Ignite Creation Date: 2024-10-26 @ 3:43 PM
Last Modification Date: 2024-10-26 @ 3:43 PM
Study NCT ID: NCT06653426
Status: RECRUITING
Last Update Posted: None
First Post: 2024-10-15

Brief Title: The NaBu Effect on Menstruation in Women
Sponsor: None
Organization: None

Study Overview

Official Title: The Effect of Sodium Butyrate on Menstrual Symptoms in Women
Status: RECRUITING
Status Verified Date: 2024-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 andor 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None