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

Vedic Lifesciences Pvt. Ltd.8 sites in 1 country200 target enrollmentApril 21, 2022

ConditionsIrritable Bowel Syndrome With Diarrhea

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Irritable Bowel Syndrome With Diarrhea
Sponsor: Vedic Lifesciences Pvt. Ltd.
Enrollment: 200
Locations: 8
Primary Endpoint: Irritable Bowel Syndrome-Symptom Severity Scale
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 21, 2022

End Date

January 13, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Vedic Lifesciences Pvt. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•i) Recurrent abdominal pain on average at least one day/week in the last three months, associated with two or more of the following criteria: Related to defecation Associated with a change in stool frequency (increase/decrease in frequency). Associated with a change in the form (appearance) of stool. ii) History of abnormal bowel movements predominantly diarrhoea (\>25% of bowel movement categorised as stool form type 6 or 7 (diarrhoea) and \<25% as stool form type 1 or 2 constipation) on BSFS).
•Participants with an IBS-SSS score ≥
•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).
•Female participants who are willing to use acceptable contraceptives during the study duration.
•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 ≥
•Gluten and/or lactose intolerant individuals.
•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/m
•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.
•Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine.
•Participants showing signs of bile acid malabsorption (BAM), as evident from the history of green colour or foul odour of the stool during the last month.

Outcomes

Primary Outcomes

Irritable Bowel Syndrome-Symptom Severity Scale

Time Frame: day 0, 28, 56, and 84

To determine the efficacy of investigational products on the participants global assessment of gastrointestinal symptoms, as assessed by change in Irritable Bowel Syndrome-Symptom Severity Scale total score at the end of study from baseline compared to placebo. Each of these 5 items is scored on a visual analogue scale from 0 to 100. Therefore, the total score on the ranges from 0 to 500. Participants are asked to respond to each question on a 100-point visual analogue scale. The higher the scores, the more will be the severity of symptoms. Participants, if required, can be categorized as having mild (75-175), moderate (175-300), Higher the score is the worst outcome and lower the score is the betterment.

Secondary Outcomes

Gut microbiome as assessed by 16S rRNA sequencing of faecal samples.(day 0 and 84)
Bristol Stool Form Scale(day 0, 28, 56, and 84)
Irritable Bowel Syndrome-Quality of Life(day 0, 28, 56, and 84)
Abdominal Pain Severity-Numeric Rating Scale score.(day 0, 28, 56, and 84)
State-Trait Anxiety Inventory-Adults score.(day 0, 28, 56, and 84)
Vitals - blood pressure(day 0, 28, 56, and 84)
Vitals - Pulse Rate(day 0, 28, 56, and 84)