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

Trial Summary

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.

How is the drug sodium butyrate unique for treating period cramps?

Sodium butyrate is unique because it is a short-chain fatty acid produced by the fermentation of dietary fiber, and it has been shown to have anti-inflammatory effects in other conditions like ulcerative colitis. This suggests it might help with period cramps by reducing inflammation, which is different from typical pain relief medications. ^{1 2 3 4 5}

What is the purpose of 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.

Research Team

Magdy P Milad, MD MS

Principal Investigator

Northwestern Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Inhibitory effect of sodium butyrate on colorectal cancer cells and construction of the related molecular network. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Sodium Butyrate Induces CRC Cell Ferroptosis via the CD44/SLC7A11 Pathway and Exhibits a Synergistic Therapeutic Effect with Erastin. [2023]

3. United States 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Clinical pharmacology of sodium butyrate in patients with acute leukemia. [2019]

5. China pubmed.ncbi.nlm.nih.gov

[Investigation of the effect of Na-butyrate on TNBS induced rat colitis]. [2013]