Purine Starvation Driven by Host-microbiota Maladaptation Contributes to the Pathogenesis of Irritable Bowel Syndrome

What this Trial Is About

Researchers are evaluating whether the probiotic B. subtilis can improve symptoms in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). This early phase 1, prospective, randomized study aims to understand if B. subtilis affects clinical symptoms by influencing purine metabolism in IBS-D patients. Participants are diagnosed based on Rome IV criteria and the study is sponsored by Jinling Hospital, China. Participants are randomly assigned to receive either B. subtilis probiotics or placebo capsules taken orally as 2 capsules three times daily for one month. The study uses a double-blind design where researchers do not know which treatment is given, and a senior gastroenterologist prescribes the medication. The intervention period lasts for four weeks. During the study, clinical symptoms and stool samples are collected before and after the treatment period to assess changes. The main outcome measured is the IBS Symptom Severity Score (IBS-SSS) at six months after intervention. Researchers also evaluate purine concentration in stool samples. Participation involves symptom monitoring, sample collection, and follow-up over six months to assess treatment effects and safety.

B.Subtilis Attenuate Symptoms in Diarrhea-predominant Irritable Bowel Syndrome by Increasing Hypoxanthine Biosynthesis