NCT06653426

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
7mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 1, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2 years

First QC Date

October 15, 2024

Last Update Submit

April 23, 2026

Conditions

Menstrual Symptoms

Outcome Measures

Primary Outcomes (1)

  • Change in Average Menstrual Symptom Scores

    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.

    Baseline period (one menstrual cycle before starting NaBu) and the 12-week treatment period.

Study Arms (1)

Sodium butyrate (NaBu)

EXPERIMENTAL

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.

Dietary Supplement: Sodium Butyrate (NaBu)

Interventions

Sodium Butyrate (NaBu)DIETARY_SUPPLEMENT

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.

Sodium butyrate (NaBu)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University - Northwestern Medicine, Lavin Family Pavilion

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (9)

  • 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

    BACKGROUND

  • 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: 22738315BACKGROUND

  • 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.

    BACKGROUND

  • 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: 16303757BACKGROUND

  • 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: 27449927BACKGROUND

  • 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: 28702095BACKGROUND

  • 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: 24868283BACKGROUND

  • 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: 11826265BACKGROUND

  • Attar E, Bulun SE. Aromatase and other steroidogenic genes in endometriosis: translational aspects. Hum Reprod Update. 2006 Jan-Feb;12(1):49-56. doi: 10.1093/humupd/dmi034. Epub 2005 Aug 25.

    PMID: 16123052BACKGROUND

MeSH Terms

Interventions

Butyric Acid

Intervention Hierarchy (Ancestors)

ButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • Magdy P Milad, MD MS

    Northwestern Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

juan A avitia, MS

CONTACT

312-694-6447juan.avitia1@nm.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Division Chief, MIGS; Medical Director, Center for Complex Gynecology

Study Record Dates

First Submitted

October 15, 2024

First Posted

October 22, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

US(1)