Sodium Butyrate for Period Cramps

Overseen By Adaeze A Emeka

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Magdy Milad, MD

Must not be taking: Antacids

Disqualifiers: Pregnancy, Lactose intolerance, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Sodium Butyrate (NaBu) can reduce period cramps and other menstrual symptoms when taken daily for 12 weeks. Participants will take NaBu tablets once a day and record their symptoms in an electronic diary. Women who regularly experience significant menstrual symptoms, such as cramps, may be suitable candidates. The study excludes individuals with certain digestive issues or intolerances, such as lactose intolerance, and those who require daily antacids. As an unphased trial, this study provides participants the opportunity to contribute to valuable research that could enhance menstrual health.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study coordinators for more details.

Is there any evidence suggesting that Sodium Butyrate is likely to be safe for humans?

Research has shown that sodium butyrate is generally safe as a dietary supplement. Gut bacteria naturally produce this type of fatty acid. While it is safe for most people, some might experience mild allergic reactions. Handle it with care, as it can cause serious eye damage if it comes into contact with the eyes.

Researchers are also studying sodium butyrate for its potential to relieve menstrual symptoms. As with any supplement or medication, consulting a healthcare provider is advisable, especially if there are any health concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sodium Butyrate is unique because it targets menstrual pain in a novel way by using a naturally occurring compound with anti-inflammatory properties. While most treatments for period cramps, like NSAIDs and hormonal contraceptives, focus on reducing inflammation or hormonal regulation, Sodium Butyrate works by potentially modifying gut health and systemic inflammation through its action as a short-chain fatty acid. Researchers are excited about its potential to offer a more holistic approach to managing menstrual symptoms, especially for those who prefer non-hormonal and non-pharmaceutical options.

What evidence suggests that Sodium Butyrate might be an effective treatment for period cramps?

Research has shown that sodium butyrate, a substance produced by gut bacteria, might help reduce menstrual symptoms. Studies have found that sodium butyrate can ease symptoms similar to those experienced during menstrual periods. For example, female students who took sodium butyrate reported fewer symptoms during their cycles. This trial will administer sodium butyrate to participants to assess its effectiveness in reducing menstrual symptoms. Sodium butyrate may work by blocking certain enzymes and activating specific cell parts, which can reduce inflammation and pain, making it a promising option for menstrual relief. ^{1 2 5 6 7}

Who Is on the Research Team?

Magdy P Milad, MD MS

Principal Investigator

Northwestern Medicine

Are You a Good Fit for This Trial?

This trial is for women who are 18 years or older, whether they have regular or irregular periods, and suffer from menstrual symptoms. Participants must have experienced an average symptom score of at least 3 out of 10 during a pre-study period.

Inclusion Criteria

I am currently having menstrual periods.

I experience menstrual symptoms with a severity of at least 3 out of 10.

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants record baseline menstrual symptoms for one menstrual cycle before starting NaBu

4 weeks

Self-reported via eDiary

Treatment

Participants take 2.4 grams of Sodium Butyrate (NaBu) daily for 12 weeks and record symptom severity in an electronic diary

12 weeks

Self-reported via eDiary

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sodium Butyrate (NaBu)

Trial Overview The study tests the effects of taking Sodium Butyrate (NaBu) once daily on reducing menstrual symptoms in women over a course of 12 weeks.

How Is the Trial Designed?

Group I: Sodium butyrate (NaBu) Experimental Treatment 1 Intervention

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.

Sodium Butyrate (NaBu) is already approved in United States, European Union for the following indications:

Approved in United States as Sodium Butyrate for:

• Constipation
• Inflammatory bowel disease

Approved in European Union as Sodium Butyrate for:

• Constipation
• Inflammatory bowel disease

Who Is Running the Clinical Trial?

Magdy Milad, MD

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

Sodium butyrate (NaB) significantly reduces the severity of ulcerative colitis in a mouse model, improving survival rates and various health indicators such as colon length and disease activity index.

NaB works by inhibiting oxidative stress and inflammation through the activation of the COX-2/Nrf2/HO-1 pathway, while also promoting mitophagy, which helps protect cells from damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium Butyrate Inhibits Oxidative Stress and NF-κB/NLRP3 Activation in Dextran Sulfate Sodium Salt-Induced Colitis in Mice with Involvement of the Nrf2 Signaling Pathway and Mitophagy. Bian, Z., Zhang, Q., Qin, Y., et al.[2023]

Na-butyrate enema significantly improved symptoms of TNBS-induced colitis in rats, showing similar effectiveness to the standard treatment, SASP, in reducing colonic injury and inflammation.

The study found that Na-butyrate not only helped in healing the colonic mucosa but also increased the mitotic index, indicating enhanced cell proliferation compared to SASP, suggesting a potential mechanism for its therapeutic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Investigation of the effect of Na-butyrate on TNBS induced rat colitis]. Hu, R., Ouyang, Q., Wang, H.[2013]

Sodium butyrate (NaB) effectively reduces the proliferation, invasion, and metastasis of colorectal cancer (CRC) cells in a dose- and time-dependent manner, promoting apoptosis and causing a G1 phase cell cycle block.

The study identified 666 differentially expressed mRNAs and 30 lncRNAs linked to NaB's effects on CRC, with specific mRNAs like HMGA2, LOXL2, and ST7 showing significant correlations with patient prognosis, highlighting NaB's potential as a therapeutic agent through complex molecular mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory effect of sodium butyrate on colorectal cancer cells and construction of the related molecular network. Xi, Y., Jing, Z., Wei, W., et al.[2023]

Sodium butyrate (NaB) effectively induces ferroptosis and apoptosis in colorectal cancer (CRC) cells (HCT-116), while having minimal effects on normal intestinal cells (FHC), suggesting a targeted therapeutic potential for CRC.

NaB operates through the CD44/SLC7A11 signaling pathway to promote cell death in CRC, and it shows a synergistic effect when combined with the ferroptosis inducer Erastin, indicating a promising strategy for enhancing CRC treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sodium Butyrate Induces CRC Cell Ferroptosis via the CD44/SLC7A11 Pathway and Exhibits a Synergistic Therapeutic Effect with Erastin. Bian, Z., Sun, X., Liu, L., et al.[2023]

In a study involving 9 patients with various types of leukemia, sodium butyrate was administered intravenously for 10 days, resulting in a significant increase in plasma butyrate levels, but no significant changes in bone marrow cytology or peripheral white blood cell counts were observed, indicating a lack of clinical efficacy.

Despite the absence of toxicity, the short half-life of sodium butyrate (approximately 6.1 minutes) and the low plasma concentrations achieved compared to those used in effective in vitro studies may explain the limited therapeutic effect in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of sodium butyrate in patients with acute leukemia. Miller, AA., Kurschel, E., Osieka, R., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06653426

NCT06653426 | The NaBu Effect on Menstruation in Women 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11644728/

Butyrate as a Potential Modulator in Gynecological Disease ... This review investigates the therapeutic potential of butyrate, a short-chain fatty acid (SCFA) produced by gut microbiota, in the prevention and treatment ...

3. withpower.com withpower.com/trial/phase-menstrual-symptoms-9-2024-960cc

Sodium Butyrate for Period Cramps Na-butyrate enema significantly improved symptoms of TNBS-induced colitis in rats, showing similar effectiveness to the standard treatment, SASP, in reducing ...

4. journals.sagepub.com journals.sagepub.com/doi/10.3233/NHA-240005

Investigation of the tolerability and potential health benefits ... Results of the current study data indicates possible effects of butyrate's HDAC activity and G-protein coupled receptor activation, albeit ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/condition/124/premenstrual-syndrome

Premenstrual Syndrome Clinical Research Trials Sodium butyrate (NaBu) is a food supplement readily ... effective in reducing the symptoms experienced by female students during the menstrual period.

6. acs.org acs.org/molecule-of-the-week/archive/s/sodium-butyrate.html

Sodium butyrate Sodium butyrate hazard information* ; Serious eye damage/eye irritation, category 1, H318—Causes serious eye damage, Chemical Safety Warning.

7. natu.care natu.care/uk/health/sodium-butyrate

Sodium butyrate side effects, benefits, and deficiency ... Sodium butyrate is considered a safe dietary supplement, but may cause allergic reactions in some people. It should also be avoided by people ...