05.02.24
A new human clinical study found that supplementation with ADM’s ES1 probiotic (Bifidobacterium longum CECT 7347), as well as a heat-treated version of it (HT-ES1) significantly improved self-reported symptoms of IBS as well as self-reported quality of life scores in a population of 200 people with IBS. The findings were published in Gut Microbes.
“Digestive health can have a huge impact on everyday quality of life, and this study’s results are key to us delivering solutions that can help consumers focus on their daily activities instead of their abdominal discomfort,” said Dr. Richard Day, vice president of medical affairs and clinical development at ADM. “The trial is the culmination of many years’ hard work, by different ADM teams, across multiple sites and countries.”
Study Details
The multi-center randomized, double-blind, placebo-controlled human clinical trial enrolled 200 adults from 18 to 65 years old with IBS-D, who either received one billion CFUs of ES1, 2.5 billion equivalent cells of the heat-treated postbiotic version, or a placebo over the course of 84 days.
The primary endpoints of the study were changes in IBS-Symptom Severity Scale (IBS-SSS) scores, as well as scores in a quality of life survey.
In each of the treatment groups, statistically significant and clinically meaningful improvements were observed for both self-reported symptom severity as well as overall self-reported quality of life, compared to placebo.
Improvements in other secondary outcomes were also achieved, such as frequency of watery stools, a significant reduction of mean APS-NRS score which measures abdominal discomfort, and a significant reduction in self-reported stress versus placebo, as measured through the State-Trait Anxiety Index.
“The findings from this robust three-arm clinical trial build upon the growing body of evidence showing how supporting the health of the gut microbiome can address aspects of a person’s health and well-being, including digestive health,” said Day. “Taken together with the already extensive preclinical data generated for these two microbiome solution products, this manuscript adds to the already strong scientific dossier for ES1 and HT-ES1. And, crucially, this is the first clinical trial to be published using the pioneering HT-ES1.”
As a postbiotic, HT-ES1 retains its functionality through various formulation environments like high heat or water content, and formulators don’t need to make the typical adaptations needed with probiotics.
“Digestive health can have a huge impact on everyday quality of life, and this study’s results are key to us delivering solutions that can help consumers focus on their daily activities instead of their abdominal discomfort,” said Dr. Richard Day, vice president of medical affairs and clinical development at ADM. “The trial is the culmination of many years’ hard work, by different ADM teams, across multiple sites and countries.”
Study Details
The multi-center randomized, double-blind, placebo-controlled human clinical trial enrolled 200 adults from 18 to 65 years old with IBS-D, who either received one billion CFUs of ES1, 2.5 billion equivalent cells of the heat-treated postbiotic version, or a placebo over the course of 84 days.
The primary endpoints of the study were changes in IBS-Symptom Severity Scale (IBS-SSS) scores, as well as scores in a quality of life survey.
In each of the treatment groups, statistically significant and clinically meaningful improvements were observed for both self-reported symptom severity as well as overall self-reported quality of life, compared to placebo.
Improvements in other secondary outcomes were also achieved, such as frequency of watery stools, a significant reduction of mean APS-NRS score which measures abdominal discomfort, and a significant reduction in self-reported stress versus placebo, as measured through the State-Trait Anxiety Index.
“The findings from this robust three-arm clinical trial build upon the growing body of evidence showing how supporting the health of the gut microbiome can address aspects of a person’s health and well-being, including digestive health,” said Day. “Taken together with the already extensive preclinical data generated for these two microbiome solution products, this manuscript adds to the already strong scientific dossier for ES1 and HT-ES1. And, crucially, this is the first clinical trial to be published using the pioneering HT-ES1.”
As a postbiotic, HT-ES1 retains its functionality through various formulation environments like high heat or water content, and formulators don’t need to make the typical adaptations needed with probiotics.
