Recruiting

NaBu

Sponsor:

Magdy Milad, MD

Code:

NCT06653426

Conditions

Menstrual Symptoms

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sodium Butyrate (NaBu)

Study Details

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.

Conditions

Menstrual Symptoms

Study ID

NCT06653426

Start date

Oct 1, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Sodium butyrate (NaBu)

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.

Interventions

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 measure

  • Change in Average Menstrual Symptom Scores [ Time Frame: Baseline period (one menstrual cycle before starting NaBu) and the 12-week treatment period. ]

Central Contacts and Locations

Central contacts

juan A avitia, MS

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

Locations

Northwestern University - Northwestern Medicine, Lavin Family Pavilion

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Magdy P Milad, MD MS

312-694-6447mmilad@nm.org

Juan A Avitia, MB BCh BAO MPH

312-926-0757juan.avitia1@nm.org

More Information

Sponsor

Magdy Milad, MD

Last update posted

Apr 29, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Magdy Milad, MD on 2026-04-29.