Propionate and Butyrate for Intestinal Health

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two supplements, microencapsulated sodium propionate and microencapsulated sodium butyrate, might improve gut health. These substances naturally form in the intestines when fibers break down and may protect the gut, especially for individuals receiving donor stem cell transplants, who often experience gut issues. The study aims to determine if these supplements can enhance the gut's natural defenses and assist in future treatments. Suitable candidates for this study are those without chronic gut diseases or migraines and who are not currently taking these supplements. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

Do I have to stop taking my current medications?

If you are currently taking butyrate or propionate supplements, you will need to stop them at least 7 days before starting the study and for the entire duration of the study. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is there any evidence suggesting that microencapsulated sodium propionate and butyrate are likely to be safe for humans?

Research has shown that both microencapsulated sodium propionate and sodium butyrate are generally safe. In animal studies, these substances improved gut health without causing harm. One study on sodium propionate found it strengthened the gut barrier and positively altered gut bacteria, with no safety issues reported.

For sodium butyrate, studies have also shown it is safe. Some individuals experienced mild side effects, but these were not serious. Other research suggests sodium butyrate can help with gut problems and is considered safe.

Overall, both supplements have been used without major safety concerns. This trial is in an early phase, primarily testing to ensure safety and determine the best dose. This step is standard to ensure treatments are safe for wider use.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments, microencapsulated sodium butyrate and sodium propionate, because they offer a novel approach to improving intestinal health. Unlike standard options that often focus on suppressing symptoms or inflammation, these treatments aim to enhance gut health by delivering beneficial short-chain fatty acids directly to the intestine. The microencapsulation technique ensures that the active ingredients are protected as they pass through the digestive tract, allowing for more efficient absorption. This innovative delivery method could lead to quicker and more effective results, providing a new avenue for managing intestinal health.

What evidence suggests that propionate and butyrate supplementation could be effective for intestinal health?

Research has shown that propionate and butyrate can improve gut health. Higher levels of these compounds may strengthen the gut lining, which is crucial for maintaining a healthy digestive system. Studies also indicate that propionate supports the immune system and aids in energy use. Additionally, microencapsulated sodium butyrate has eased stomach issues like pain and diarrhea. In this trial, participants will receive microencapsulated sodium propionate and microencapsulated sodium butyrate to evaluate their potential benefits for individuals with gut problems, such as those undergoing donor stem cell transplants.34567

Who Is on the Research Team?

KS

Karamjeet S Sandhu

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for healthy adults who want to help researchers study how certain supplements affect gut health. People with current illnesses or medical conditions are not eligible.

Inclusion Criteria

Documented informed consent of the participant and/or legally authorized representative
Ability to read, understand, and willingness to sign a written informed consent
Ability to understand English to fill out required forms (e.g. Pill Diary and Symptom Diary)
See 2 more

Exclusion Criteria

History of allergic reactions to compounds of similar chemical or biologic composition to study agent
I am currently pregnant, breastfeeding, or planning to become pregnant.
I have a history of migraines or chronic digestive diseases like Crohn's disease.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive microencapsulated sodium propionate orally four times daily for 1 week, followed by microencapsulated sodium propionate and butyrate for another week.

2 weeks
Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week
Blood sample collection

What Are the Treatments Tested in This Trial?

Interventions

  • Microencapsulated Sodium Butyrate
  • Microencapsulated Sodium Propionate

Trial Overview

The study tests the effects of taking microencapsulated sodium butyrate and propionate—natural compounds made in the gut from fiber—on intestinal health. Participants may provide samples, and results could guide future use in stem cell transplant patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Supportive care (mPB)Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials
614
Recruited
1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

The effectiveness of microencapsulated sodium butyrate at ...

A statistically significant improvement in severity of abdominal pain was noticed (p < 0.001). Moreover, flatulence, diarrhea, constipation, urgent pressure ...

Use of Sodium Butyrate and Its Microencapsulated Forms in ...

There is insufficient and limited data confirming the effectiveness of MSB® in intestinal disease. The available studies suggest that MSB ...

Efficacy of Microencapsulated Sodium Butyrate as Add-On ...

RESULTS: In the MSB group, 26 patients (51%) showed clinical improvement (P=0.005), 16 (31.4%) achieved clinical remission (P=0.004), and 21 (42.2%) reached ...

Effect of microencapsulated sodium butyrate on abdominal ...

After 12 weeks, the sodium butyrate group showed a significant reduction in gastrointestinal symptoms including abdominal pain (p = 0.001), ...

The Efficacy of Sodium Butyrate and Probiotics in Patients ...

According to current IBS management guidelines, probiotic administration reduces IBS-associated symptoms and improves the quality of life.

Efficacy of Microencapsulated Sodium Butyrate as Add ... - PMC

MSB is a safe and effective adjunct therapy for mild-to-moderate UC, leading to clinical improvement, remission, and endoscopic improvement. Further studies are ...

Efficacy and Safety of a Mixture of Microencapsulated ...

A biotic mixture consisting of microencapsulated butyrate, probiotics, and small amounts of scFOSs is safe and effective in improving gastrointestinal symptoms ...