Effect of Oral Intake of APsulloc 331261 (GTB1) on Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized, Double-Blind, Placebo-Controlled Study.

Irritable bowel syndrome (IBS) causes intestinal discomfort, gut dysfunction, and poor quality of life. This randomized, double-blind placebo-controlled trial evaluated the efficacy of (., formerly ) APsulloc 331261 (GTB1) from green tea leaves in participants with diarrhea-predominant irritable bowel syndrome (IBS-D). Twenty-seven participants meeting the Rome IV diagnostic criteria were randomized for GTB1 or placebo ingestion for four weeks and follow-up for two weeks. The efficacy endpoints included adequate global relief of symptoms, assessment of intestinal discomfort symptom severity and frequency, stool frequency, satisfaction, and fecal microbiome abundance. Of all participants, 94.4% and 62.5% reported global relief of symptoms in the GTB1 and placebo groups, respectively, with significant differences ( = 0.037). GTB1 significantly reduced the severity and frequency of abdominal pain, bloating, and feeling of incomplete evacuation. The frequencies of diarrhea were decreased -45.89% and -26.76% in the GTB1 and placebo groups, respectively ( = 0.045). Hence, GTB1 ingestion improved IBS-D patient quality of life. After four weeks treatment, the relative abundance of was higher in the GTB1 than in the placebo group ( = 0.010). Our results showed that GTB1 enhanced intestinal discomfort symptoms, defecation consistency, quality of life, beneficial microbiota, and overall intestinal health.