Hi Dr. Jeffrey Mark, this week I’d like to share with you a study just released from the respected British medical journal The Lancet, equivalent to our New England Journal of Medicine, entitled “Efficacy and safety of spore-forming probiotics in the treatment of functional dyspepsia: a pilot randomized, double-blind, placebo-controlled trial” by Dr. Lucas Wauters, MD published August 3rd, 2021. This study compared the effectiveness of using certain spore-based probiotics in treating functional dyspepsia in conjunction with or without proton pump inhibitors (medications like Prilosec, Prevacid, or Pantoprazole). Functional dyspepsia, as defined by the Rome IV criteria involves 1 or more of the following:
- Bothersome postprandial fullness (example fullness, bloating, or gas after eating)
- Bothersome early satiation (for example having to stop eating way before you’ve “finished” the meal)
- Bothersome epigastric pain (pain in the area just below the sternum or chest)
- Bothersome epigastric burning (burning just below the sternum or chest)
Secondly, no evidence of structural disease (including at upper endoscopy or esophagogastroduodenoscopy) is likely to explain the symptoms.
These symptoms must be present for at least the 3 months before making the diagnosis and having at least started 6 months prior.
Many people suffering from these symptoms have been traditionally treated with acid suppression usually in the form of proton pump inhibitors. However, many continue to have symptoms and there are side effects to proton pump inhibitors leading to low magnesium, low iron or red blood cell count (anemia), B vitamin deficiency, decrease in kidney function over time, and possible long-term cognitive effects. This study looked at the efficacy and safety of using a natural treatment with Bacillus strains of bacteria in treating dyspepsia alone or in conjunction with proton pump inhibitors.
This single-center, randomized, double-blind, placebo-controlled pilot trial that took place at University Hospitals Leuven (Leuven, Belgium) with adult patients (≥18 years) with functional dyspepsia (as defined by Rome IV criteria, on proton-pump inhibitors or off proton-pump inhibitors) that were randomly assigned by a computer and stratified by proton-pump inhibitor status, to receive 8 weeks of treatment with probiotics (2 Bacillus species at 2.55 Billion colony-forming units per capsule) or placebo consumed twice per day, followed by an open-label extension phase of 8 weeks. Individuals with a history of abdominal surgery, diabetes, coeliac or inflammatory bowel disease, active psychiatric conditions, and use of immunosuppressant drugs, antibiotics, or probiotics in the past 3 months were excluded. All patients and on-site study personnel were masked to treatment allocation in the first 8 weeks. Symptoms, immune activation, and fecal microbiota were assessed and recorded. The primary endpoint was a decrease of at least 0.7 in the postprandial distress syndrome (PDS) score of the Leuven Postprandial Distress Scale in patients with a baseline PDS score of 1 or greater (at least mild symptoms), assessed in the intention-to-treat population.
They looked at 93 individuals for eligibility and included 68 people that fit the criteria for functional dyspepsia. There were 51 women, average age 40.1 with 34 on proton pump inhibitors. 32 were assigned to probiotics and 36 to placebo (or “sugar” pill). Clinical responders were higher in the probiotics group (48%) than the placebo group (20%) which was statistically significant with a p-value of 0.028 (less than 0.05). The number of people with any side effects was about the same in both groups demonstrating comparable safety. 2 had serious adverse events with appendicitis and syncope which were found to be unrelated to the probiotic being studied.
The conclusion was that these Bacillus strains were efficacious and safe in the treatment of functional dyspepsia. Participants had potentially beneficial immune and microbial changes, which could provide insights into possible underlying mechanisms as future predictors or treatment targets.
AFH Biospore has both of the Bacillus strains studied and a 3rd very helpful strain with a total of 4 Billion colony forming units per capsule ( 1.45 billion more bacteria per capsule than the amount used in the study) and we have successfully helped people with dyspepsia and in many cases wean off proton pump inhibitors to avoid the side effects leading to low magnesium, low iron or red blood cell count (anemia), B vitamin deficiency, decrease in kidney function over time, and possible long term cognitive effects. You can click on this link or the link below to get AFH Biospore.
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