Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06653426

The Effect of Sodium Butyrate on Menstrual Symptoms in Women

Led by Magdy Milad, MD · Updated on 2026-04-29

15

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study the effects of Sodium Butyrate (NaBu), a dietary supplement, on menstrual symptoms in women. The study focuses on common symptoms such as abdominal or pelvic cramping, lower back pain, bloating, mood swings, and irritability, which are thought to be linked to estrogen production in certain cells. Researchers believe that NaBu may reduce these symptoms by inhibiting a key enzyme involved in estrogen synthesis. Participants will take 2.4 grams of Sodium Butyrate daily in tablet form for 12 weeks. They will self-administer the supplement and record their daily symptom severity using an electronic diary. The study compares symptom scores recorded before starting NaBu with those during the 12-week treatment to evaluate changes. During the study, participants will have regular follow-ups to monitor progress and any side effects. Researchers will measure changes in average menstrual symptom scores between the baseline period (one menstrual cycle before starting NaBu) and the treatment period. The total participation involves daily symptom tracking and supplement use over 12 weeks.

CONDITIONS

Brief Title

The NaBu Effect on Menstruation in Women

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Currently menstruating regularly or irregularly
  • Experiencing menstrual symptoms with an average baseline severity score of at least 3 out of 10 for at least one symptom during the initial rating period
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding, or planning to become pregnant
  • History of bloating or sensitive gut requiring low fiber intake
  • Known lactose intolerance, FODMAP intolerance, or small intestinal bacterial overgrowth (SIBO)
  • Requires daily antacids during the study
  • Known or suspected chronic hypertension
  • Post-menopausal status

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 12 weeks

Participants self-administer Sodium Butyrate (NaBu) daily for 12 weeks to evaluate its effect on menstrual symptoms. They maintain an electronic diary (eDiary) to record daily symptom severity during this period.

Daily self-administration and symptom recording via eDiary

Trial Site Locations

Total: 1 location

1

Northwestern University - Northwestern Medicine, Lavin Family Pavilion

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

J

juan A avitia, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Santanu Deb, Jianfeng Zhou, Sanober A Amin...

https://pubmed.ncbi.nlm.nih.gov/16303757

Maternal sodium butyrate supplement elevates the lipolysis in adipose tissue and leads to lipid accumulation in offspring liver of weaning-age rats.

Jiabin Zhou, Shixing Gao, Jinglong Chen...

https://pubmed.ncbi.nlm.nih.gov/27449927