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

NCT05339243 | Completed

• 1 other identifier: ADM/211001/BLE/IBS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

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.

Conditions

Irritable Bowel Syndrome With Diarrhea

Outcome Measures

Primary Outcomes (1)

• Irritable Bowel Syndrome-Symptom Severity Scale

  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.

  day 0, 28, 56, and 84

Secondary Outcomes (7)

• 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

Study Arms (3)

ES 1

ACTIVE COMPARATOR

Two capsules orally once daily after breakfast for 84 days

Other: ES 1

HT ES1

ACTIVE COMPARATOR

Two capsules orally once daily after breakfast for 84 days

Other: HT ES1

Placebo

PLACEBO COMPARATOR

Two capsules orally once daily after breakfast for 84 days

Other: Placebo

Interventions

ES 1 OTHER

Two capsules orally once daily after breakfast for 84 days

ES 1

HT ES1 OTHER

Two capsules orally once daily after breakfast for 84 days

HT ES1

Placebo OTHER

Two capsules orally once daily after breakfast for 84 days

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 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).
• 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.

You may not qualify if:

• Participants diagnosed with anxiety as assessed by STAI-AD S- anxiety subscale score ≥ 40.
• 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/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.
• 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.
• Participants with a history of or complications from malignant tumours.
• Participation in other clinical trials in the last 90 days prior to screening
• Active smokers or using any form of smokeless tobacco.
• Participants with substance abuse problems (within two years) defined as:
• Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine dependence.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (8)

Apex Gastro Clinic and Hospital

Ahmedabad, Gujarat, 380013, India

Location

Gastroplus, Digestive disease centre

Ahmedabad, Gujarat, 380054, India

Location

Aman Hospital and research centre

Vadodara, Gujarat, 390021, India

Location

Shantaee Nursing Home

Mumbai, Maharashtra, -400067, India

Location

Dr. Sanjeev Khanna clinic

Mumbai, Maharashtra, 400059, India

Location

Stress test clinic

Mumbai, Maharashtra, 400059, India

Location

Jaipur National University Institute for Medical Science & Research Centre

Jaipur, Rajasthan, -302017, India

Location

Dr. Sudhir Maharshi clinic

Jaipur, Rajasthan, 302001, India

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomised, double-blind, placebo-controlled, parallel-group multicentre study

Study Record Dates

• First Submitted: April 13, 2022
• First Posted: April 21, 2022
• Study Start: April 21, 2022
• Primary Completion: January 13, 2023
• Study Completion: January 13, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-09

Locations

IN (8)