RECRUITING

The NaBu Effect on Menstruation in Women

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effect of Sodium Butyrate on Menstrual Symptoms in Women

Quick Facts

Study Start:2024-10

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06653426

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Adaeze A Emeka, MB BCh BAO MPH

CONTACT

3125033492

adaeze.emeka@nm.org

Principal Investigator

Magdy P Milad, MD MS

PRINCIPAL_INVESTIGATOR

Northwestern Medicine

Study Locations (Sites)

Northwestern University - Northwestern Medicine, Lavin Family Pavilion

Chicago, Illinois, 60611

United States

Collaborators and Investigators

Sponsor: Magdy Milad, MD

Magdy P Milad, MD MS, PRINCIPAL_INVESTIGATOR, Northwestern Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10

Study Completion Date2025-10

Study Record Updates

Study Start Date2024-10

Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

Menstrual Symptoms