The NaBu Effect on Menstruation in Women

ConditionMenstrual Symptoms

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18+

SponsorMagdy Milad, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: Sodium butyrate (NaBu)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Magdy Milad, MD

Lead sponsor

Northwestern University

Sponsor institution

Source ClinicalTrials.gov

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