A new clinical trial has demonstrated remarkable efficacy for SEBiotic®, a spore-forming probiotic, in treating drug-induced constipation associated with Functional Gastrointestinal Disorders (FGIDs). The study showed resolution of constipation in 96.4% of patients after just 35 days of treatment.
The double-blind, randomized, interventional, parallel, controlled clinical trial, published in Global Advances in Integrative Medicine and Health, evaluated the probiotic's impact on clinical symptoms, safety, tolerability, and quality of life parameters in patients suffering from drug-induced constipation.
Significant Clinical Improvements
SEBiotic®, which contains the probiotic strain Bacillus coagulans LBSC, demonstrated substantial improvements across multiple gastrointestinal parameters. Beyond the primary finding of constipation resolution in nearly all participants, the study documented significant improvements in stool consistency and expulsion. Patients also experienced reductions in the degree of constipation, occurrence of hard stools, and improvements in defecation frequency.
These findings are particularly significant given the prevalence of drug-induced constipation, which affects millions of patients on chronic medication regimens worldwide. Current treatment options often provide inadequate relief or come with unwanted side effects, creating a substantial unmet medical need.
Quality of Life Benefits
Perhaps equally important were the quality of life improvements observed in the study. SEBiotic® supplementation was associated with positive changes in mental health, general health perceptions, bodily pain, and physical and social functioning. These improvements suggest the probiotic's benefits extend beyond symptom relief to overall wellbeing.
"It is well known that chronic drug therapies can cause an imbalance in the gut microbiome, leading to unpleasant symptoms that negatively impact quality of life," explained Reshma Rathi, Vice President of Specialty Enzymes & Probiotics. "The study clearly illustrates SEBiotic® offers powerful support for those suffering from drug-induced constipation related to FGIDs."
Safety and Tolerability Profile
The clinical trial also confirmed that SEBiotic® was well-tolerated and safe for consumption, with no significant adverse events reported. This safety profile is crucial for patients with FGIDs, who often have sensitive gastrointestinal systems that can react poorly to interventions.
Mechanism of Action
While the study didn't explicitly detail the mechanism of action, spore-forming probiotics like Bacillus coagulans are known for their ability to survive the harsh conditions of the upper gastrointestinal tract and reach the intestines intact. Once there, they can help restore microbial balance disrupted by medications.
Many drugs, including opioids, antidepressants, antipsychotics, and certain blood pressure medications, can disrupt normal gut function and microbial composition, leading to constipation and other gastrointestinal symptoms. SEBiotic® appears to effectively counteract these disruptions.
Manufacturing Standards
Specialty Enzymes & Probiotics, the manufacturer of SEBiotic®, emphasizes its commitment to quality in producing the probiotic. The company has over 45 years of fermentation experience and manufactures its products in NSF GMP-certified facilities with numerous accreditations, including Non-GMO Project verification, OK Kosher, and ISA Halal certification.
All ingredients and finished products undergo extensive testing in the company's ISO-17025-certified laboratory, which also provides third-party testing services. The company is a member of both the International Probiotic Association and the Council for Responsible Nutrition.
Clinical Implications
For healthcare providers treating patients with drug-induced constipation, these findings offer a promising new intervention that addresses a common and distressing side effect of many medication regimens. The high efficacy rate of 96.4% suggests SEBiotic® could become an important addition to clinical protocols for managing medication side effects, potentially improving treatment adherence by reducing gastrointestinal discomfort.
The study adds to a growing body of evidence supporting the role of targeted probiotic interventions in managing specific gastrointestinal conditions, moving beyond general gut health claims to condition-specific applications backed by clinical research.
