Evaluating the Safety and Efficacy of the Probiotic Bifidobacterium Longum ES1 and the Post Bioti… (NCT05339243) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Safety and Efficacy of the Probiotic Bifidobacterium Longum ES1 and the Post Biotic Heat-treated Bifidobacterium Longum ES1 (HT-ES1) on IBS Symptom Severity in Patients With Diarrhoea Predominant Irritable Bowel Syndrome
India200 participantsStarted 2022-04-21
Plain-language summary
Randomized controlled clinical study has been proposed to evaluate the safety and efficacy of ES1 probiotic strain and heat-treated ES1 postbiotic strain in individuals suffering from IBS-D.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Males and females aged ≥18 to ≤ 65 years.
✓. Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
✓. Participants with an IBS-SSS score ≥ 175.
✓. Participants who test negative for COVID-19 by Rapid Antigen Lateral Flow Test Device.
✓. Participants who can comply and perform the procedures as per the protocol (consumption of study medications, biological sample collection procedures, and study visit schedule).
✓. Participants who are literate enough to understand the purpose of the study and their rights.
✓. Participants who are able to give written informed consent and are willing to participate in the study.
Exclusion criteria
✕. Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥ 40.
✕. Abnormal Thyroid Stimulating Hormone (TSH) value which is (\< 0.4 to \> 4.2 mIU/L).
✕. Participants with uncontrolled type II diabetes mellitus defined as random blood glucose (RBG) \> 199 mg/dL or fasting blood glucose (FBG) \>125 mg/dL.
✕. Participants with a body mass index (BMI) ≥ 30 kg/m2.
✕. Presence of uncontrolled hypertension defined as systolic blood pressure (SBP) ≥ 140 mm Hg and/or diastolic blood pressure (DBP) ≥ 90 mm Hg.
✕. Participants with a history of intake of antibiotics (Rifaximin, metronidazole, or any other), other probiotics, prebiotics, synbiotic, proton pump inhibitors, acid sequestrants (cholestyramine, Bile colestipol), FODMAP diet, and histamine H2- receptor antagonists/H2 blockers within six weeks prior to the screening day.
✕. Participants with a history of daily intake of antidepressants (Tricyclic antidepressants, Selective serotonin reuptake inhibitors (SSRIs), and Selective serotonin-norepinephrine reuptake Inhibitors (SSNRIs)), clonidine, otilonium bromide, asimadoline, eluxadoline, diphenoxylate, antispasmodics including mebeverine and pinnaverium and anticholinergics within two weeks before the screening day.