Bacillus Subtilis Eases Dyspepsia Symptoms: Study Results

observational-study PMID: 34358486

Bacillus Subtilis Eases Dyspepsia Symptoms: Study Results

Quick Summary: A clinical trial tested spore-forming probiotics, including Bacillus subtilis, for functional dyspepsia—a common stomach condition causing pain and bloating. People taking the probiotics saw better symptom relief than those on a placebo, with 48% improving compared to 20%. The treatment was safe, with few side effects.

What The Research Found

This pilot study showed that a mix of Bacillus coagulans MY01 and Bacillus subtilis MY02 helped reduce symptoms of functional dyspepsia. Functional dyspepsia means ongoing upper stomach discomfort without a clear cause, like ulcers. The probiotics worked as a standalone treatment or alongside acid-reducing drugs called proton-pump inhibitors (PPIs).

Key results included:
- Better Response Rates: Nearly half (48%) of people on probiotics felt significant improvement, versus just 20% on placebo. This difference was statistically meaningful, with a relative risk of 1.95.
- Safety Profile: Side effects were low and similar in both groups—16% for probiotics and 33% for placebo. No serious issues linked to the probiotics; two unrelated events (appendicitis and fainting) happened later in the study.
- Bonus Effects: The probiotics may boost gut bacteria diversity and calm immune responses, like lowering inflammation markers (e.g., TNF-α). This hints at how they might help fix gut imbalances causing dyspepsia.

These findings suggest Bacillus subtilis, a tough spore-forming bacteria, could support gut health without the risks of some standard treatments.

Study Details

Who was studied: 68 adults (average age 40, 75% women) with functional dyspepsia, diagnosed using standard medical criteria (Rome IV). Half were already on PPIs for symptom control; the rest weren't.
How long: The main treatment phase lasted 8 weeks, with some follow-up afterward.
What they took: Daily capsules with 2.5 billion colony-forming units (CFU) each of Bacillus coagulans MY01 and Bacillus subtilis MY02. This equals one dose per day of the probiotic powder. The study was double-blind, so neither participants nor doctors knew who got the real thing versus placebo.

The trial ran from 2019 to 2020 at a Belgian hospital, randomly assigning people to groups for fair comparison.

What This Means For You

If you deal with functional dyspepsia—think frequent bloating, nausea, or early fullness after meals—this study points to Bacillus subtilis probiotics as a promising, natural option. It might ease symptoms better than doing nothing, especially if current meds like PPIs aren't fully helping or cause side effects.

Try It If: You're looking for gut-friendly support. Spore-forming probiotics like these survive stomach acid to reach your intestines, potentially rebuilding healthy bacteria.
Talk to Your Doctor: Don't swap out prescribed treatments; discuss adding probiotics. Results vary by person, and this combo (MY01 and MY02 strains) isn't widely available yet—look for similar Bacillus subtilis products.
Real-Life Tip: Start with a quality supplement, eat probiotic-rich foods (like fermented veggies), and track symptoms. If dyspepsia disrupts your day, this could mean fewer antacids and more comfort.

Larger studies are needed, but early signs are encouraging for safer gut relief.

Study Limitations

This was a small "pilot" trial, so results aren't set in stone. Keep these in mind:
- Small Group: Only 68 people, which limits how widely we can apply the findings to everyone.
- Short Timeframe: 8 weeks doesn't show long-term effects, like if benefits last or fade.
- One Location: Done at a single Belgian hospital, so it might not match experiences in diverse groups or other countries.
- Specific Strains: Benefits tied to these exact Bacillus subtilis and coagulans types—other versions might not work the same.
- Early Stage: As an exploratory study, it needs bigger trials to confirm safety and effectiveness for everyday use.

Overall, it's a positive step, but consult a pro before trying.
Source: PubMed | Year: 2021 | Type: Pilot RCT

Key Findings

The study found that a probiotic combination of Bacillus coagulans MY01 and Bacillus subtilis MY02 significantly improved clinical response rates in functional dyspepsia patients compared to placebo (48% vs. 20%, p=0.028). Probiotics were well-tolerated, with no significant difference in adverse events between groups.

Study Design

This was a single-centre, randomised, double-blind, placebo-controlled pilot trial conducted at University Hospitals Leuven (Belgium). A total of 68 adults (mean age 40.1 years, 75% women, 50% on proton-pump inhibitors) with functional dyspepsia (Rome IV criteria) were assigned to probiotics (n=32) or placebo (n=36) for 8 weeks. Stratification by proton-pump inhibitor use ensured balanced groups.

Dosage & Administration

Participants received daily capsules containing 2.5 × 10⁹ CFU of Bacillus coagulans MY01 and 2.5 × 10⁹ CFU of Bacillus subtilis MY02. The probiotic or placebo powder was administered once daily, with treatment lasting 8 weeks.

Results & Efficacy

Clinical Response: 48% (12/25) of probiotic recipients showed symptom improvement vs. 20% (6/30) in the placebo group (relative risk 1.95, 95% CI 1.07–4.11, p=0.028).
Safety: Adverse events occurred in 16% (5/32) of the probiotic group and 33% (12/36) of the placebo group. Two serious adverse events (appendicitis, syncope) during the open-label phase were deemed unrelated to treatment.
Secondary Outcomes: Probiotics correlated with microbial diversity shifts and immune modulation (e.g., reduced TNF-α levels), suggesting potential mechanistic pathways.

Limitations

Small Sample Size: Only 68 participants (32 probiotic, 36 placebo) limit statistical power and generalisability.
Short Duration: 8-week follow-up may not capture long-term efficacy or safety.
Single-Centre Design: Results may not apply to diverse populations.
Strain-Specific: Findings apply only to MY01 and MY02 strains; other B. subtilis strains might differ.
Open-Label Phase: Potential bias during the initial unblinded period, though randomisation mitigated this.

Clinical Relevance

This trial suggests that Bacillus subtilis MY02 (with B. coagulans MY01) may offer a safe, effective adjunct or alternative to proton-pump inhibitors for functional dyspepsia. Users should note the preliminary nature of pilot data and the need for larger, multi-centre trials to confirm efficacy. The probiotic’s spore-forming properties may enhance gut microbiota stability, though individual responses could vary. Patients currently on PPIs might benefit from discussing probiotic options with healthcare providers, but should not discontinue standard treatments without guidance.

Source: PubMed | Year: 2021 | Type: Pilot RCT