Irritable Bowel Syndrome With DiarrheaNCT05339243
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
A study testing ES 1 and HT ES1 in people with Irritable Bowel Syndrome With Diarrhea, run by Vedic Lifesciences Pvt. Ltd. at 8 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- ES 1 and HT ES1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 8 sitesIndia
- Study dates
- 21 Apr 2022to 13 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged ≥18 to ≤ 65 years.
- Participants diagnosed with diarrhoea-predominant irritable bowel syndrome (IBS-D) as per ROME IV criteria:
- 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).
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- High-risk drinking as defined by the consumption of four or more alcohol-containing beverages on any day or eight or more alcohol- containing beverages per week for women and five or more alcohol-containing beverages on any day or 15 or more alcohol- containing beverages per week for men.
- Participants having clinically significant illnesses of cardiovascular, endocrine, immune, respiratory, hepato-biliary, kidney and urinary, haematological, musculoskeletal system and/or any inflammatory disorder, tumour, and other gastrointestinal diseases.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Apex Gastro Clinic and Hospital
Ahmedabad, Gujarat, 380013
Gastroplus, Digestive disease centre
Ahmedabad, Gujarat, 380054
Jaipur National University Institute for Medical Science & Research Centre
Jaipur, Rajasthan, -302017
Dr. Sudhir Maharshi clinic
Jaipur, Rajasthan, 302001
Shantaee Nursing Home
Mumbai, Maharashtra, -400067
Dr. Sanjeev Khanna clinic
Mumbai, Maharashtra, 400059
Stress test clinic
Mumbai, Maharashtra, 400059
Aman Hospital and research centre
Vadodara, Gujarat, 390021
About this study
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
- Being tested
- ES 1, HT ES1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ES 1Other
Two capsules orally once daily after breakfast for 84 days
HT ES1Other
Two capsules orally once daily after breakfast for 84 days
PlaceboOther
Two capsules orally once daily after breakfast for 84 days
| Study group | Role | What they receive |
|---|---|---|
| ES 1 | Active comparator | Two capsules orally once daily after breakfast for 84 days Receives: Other: ES 1 |
| HT ES1 | Active comparator | Two capsules orally once daily after breakfast for 84 days Receives: Other: HT ES1 |
| Placebo | Placebo comparator | Two capsules orally once daily after breakfast for 84 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 0, 28, 56, and 84
Secondary outcomes (7)
Bristol Stool Form Scale
At the end of days 28, 56, and 84, the percentage of participants transitioning to normal stool consistency (as demonstrated by weekly BSFS score reported as 3, 4, or 5) compared to baseline scores will be identified to evaluate the efficacy of IP in comparison to placebo.
Measured: day 0, 28, 56, and 84
Irritable Bowel Syndrome-Quality of Life
Quality of life as assessed by change in Irritable Bowel Syndrome-Quality of Life.
It is a 34-item questionnaire with each item rated on a 5-point scale (34-170), with increasing scores indicating the deteriorating quality of life (Appendix-III). However, to facilitate comparisons among various measures on a standardized scale, the summed scores will be transformed to a 0 - 100 scale ranging from 0 (poor quality of life) to 100 (maximum quality of life).
Measured: day 0, 28, 56, and 84
Abdominal Pain Severity-Numeric Rating Scale score.
Abdominal pain severity as assessed by change in Abdominal Pain Severity-Numeric Rating Scale (APS-NRS) score.
score ratings include 0 - None, 1 to 3 - Mild, 4 to 6 - Moderate, 7 to 9 - Severe, and 10
= very severe.4
Measured: day 0, 28, 56, and 84
State-Trait Anxiety Inventory-Adults score.
Mental health as assessed by change in State-Trait Anxiety Inventory-Adults (STAI-AD) score. The State-Trait Anxiety Inventory has 40 items, 20 allocated to each S-Anxiety and T-Anxiety sub-scales . The range of scores for each subtest is 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale
Measured: day 0, 28, 56, and 84
Vitals - blood pressure
To evaluate the safety of IP consumption .
Normal BP ranging Systolic120 - 129 mmHg and or diastolic 80 - 84 mm Hg
Measured: day 0, 28, 56, and 84
Gut microbiome as assessed by 16S rRNA sequencing of faecal samples.
Measured: day 0 and 84
Vitals - Pulse Rate
Normal Pulse rate 60 - 100 bpm
Measured: day 0, 28, 56, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start21 Apr 2022
- Primary completion13 Jan 2023
- Study completion13 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomised, double-blind, placebo-controlled, parallel-group multicentre study
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339243
- Sponsor's protocol ID
- ADM/211001/BLE/IBS
- Status last verified
- Sep 2023
- First submitted
- 13 Apr 2022
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05339243
- Acronym / sponsor ID
- ADM/211001/BLE/IBS
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 13 Jan 2023 (actual)
- Study completion
- 13 Jan 2023 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- A randomised, double-blind, placebo-controlled, parallel-group multicentre study
| Arm | Type | Receives |
|---|---|---|
| ES 1 | Active comparator | Other: ES 1Two capsules orally once daily after breakfast for 84 days |
| HT ES1 | Active comparator | Other: HT ES1Two capsules orally once daily after breakfast for 84 days |
| Placebo | Placebo comparator | Other: PlaceboTwo capsules orally once daily after breakfast for 84 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ES 1Two capsules orally once daily after breakfast for 84 days | Other | ES 1 |
| HT ES1Two capsules orally once daily after breakfast for 84 days | Other | HT ES1 |
| PlaceboTwo capsules orally once daily after breakfast for 84 days | Other | Placebo |
Primary outcome
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.
7 secondary outcomes
Bristol Stool Form Scale
Time frame: day 0, 28, 56, and 84
Irritable Bowel Syndrome-Quality of Life
Time frame: day 0, 28, 56, and 84
Abdominal Pain Severity-Numeric Rating Scale score.
Time frame: day 0, 28, 56, and 84
State-Trait Anxiety Inventory-Adults score.
Time frame: day 0, 28, 56, and 84
Vitals - blood pressure
Time frame: day 0, 28, 56, and 84
Gut microbiome as assessed by 16S rRNA sequencing of faecal samples.
Time frame: day 0 and 84
Vitals - Pulse Rate
Time frame: day 0, 28, 56, and 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome With Diarrhea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Active, not recruiting
The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Small Intestinal Bacterial Overgrowth, SIBO
RecruitingPhase 2
A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M)
Irritable Bowel Syndrome
Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
Patients With Irritable Bowel Syndrome With Diarrhea
Not yet recruiting
Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
Functional Dyspepsia, Irritable Bowel Syndrome With Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ES 1 and HT ES1 in people with Irritable Bowel Syndrome With Diarrhea, run by Vedic Lifesciences Pvt. Ltd. at 8 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irritable Bowel Syndrome-Symptom Severity Scale (time frame: day 0, 28, 56, and 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.