The NaBu Effect on Menstruation in Women

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Magdy Milad, MD
Study ID
NCT06653426
Status
Recruiting
Apply to this trial

Conditions

  • Menstrual Symptoms

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University - Northwestern Medicine, Lavin Family PavilionChicagoIllinois60611
Magdy P Milad, MD MS
[email protected]
312-694-6447
Juan A Avitia, MB BCh BAO MPH
[email protected]
312-926-0757

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By research site
Northwestern University - Northwestern Medicine, Lavin Family Pavilion· Chicago, IL

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