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Safety and Efficacy of a Probiotic Supplement in IBS-D (IBIS)

Primary Purpose

Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Probiotic
Placebo
Sponsored by
The Archer-Daniels-Midland Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Diarrhea focused on measuring IBS, Probiotic, Irritable Bowel Syndrome, GI microbiome, Bifidobacterium

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 movements 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 Test Device. Participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study. Participants who can comply and perform the procedures as per the protocol (consumption of study products, 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 who score ≥ 40 in either the 'state' or 'trait' section of the STAI-AD questionnaire (both sections to be assessed). Participants diagnosed with Coeliac Disease. Lactose intolerant participants unless on a strict lactose free diet for at least three months before screening day with persistent symptoms of IBS-D. 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, synbiotics, food supplements with iron or calcium, peppermint oil, acid sequestrants (cholestyramine, Bile colestipol), introduced/active low 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 prior to the screening day. Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine. Participants with a history of gastrointestinal-related abdominal surgery other than hernia repair. Participants with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis. 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 GI malignant tumours. Participants with a history of or complications from other malignant tumours in the last 5 years. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints. Participation in other clinical studies in the last 90 days prior to screening day. 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 and other gastrointestinal diseases. Participants with active human immunodeficiency virus (HIV) or hepatitis A, B or C infection. Female participants being pregnant, breastfeeding or planning pregnancy in the course of the study. Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Sites / Locations

  • VizeraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Arm receiving investigation product (probiotic)

Arm receiving placebo

Outcomes

Primary Outcome Measures

Change in total irritable bowel syndrome symptom severity score (IBS-SSS)
Change in IBS-SSS totals score (max 500 points) from baseline to day 28, day 58 and day 84, where higher scores mean worse outcomes

Secondary Outcome Measures

Percentage of population achieving a normal stool consistency
Percentage of the population achieving normal stool consistency, defined as over 75% of total bowel movements classified as stool form type 3, 4, and 5 on Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage at baseline compared to weekly percentage at day 28, 58 and 84.
Percentage of population without diarrhea
Percentage of the population where less than 25% of bowel movements are diarrhea, defined as stool form type 6 or 7 on the Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage calculated throughout study and compared to baseline weekly percentage.
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Change in quality of life, assessed by change in the IBS-QOL total score (max 100 points) between baseline and day 28, day 58 and day 84, where higher scores mean better quality of life
Change in State-Trait Anxiety Inventory for Adults (STAI-AD) score
Mental health as assessed by change in STAI-AD S-anxiety subscale score (max: 80), between baseline and day 28, 58 and 84, where higher scores mean more severe anxiety symptoms
Gut microbiome compositional changes
Change in gut microbiome composition, as assessed by shotgun sequencing of faecal samples, between baseline and study end (day 84)
Use of Rescue Medication
Comparison in total cumulative use of rescue medications between the two study arms at study end (day 84)

Full Information

First Posted
February 22, 2023
Last Updated
July 20, 2023
Sponsor
The Archer-Daniels-Midland Company
Collaborators
Vizera d.o.o.
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1. Study Identification

Unique Protocol Identification Number
NCT05754177
Brief Title
Safety and Efficacy of a Probiotic Supplement in IBS-D
Acronym
IBIS
Official Title
Evaluating the Safety and Efficacy of a Probiotic on IBS Symptom Severity in Patients With Diarrhoea-predominant Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2023 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Archer-Daniels-Midland Company
Collaborators
Vizera d.o.o.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess the safety and efficacy of a single probiotic strain on symptom severity in patients with diarrhea-predominant Irritable Bowel Syndrome (IBS-D).
Detailed Description
This is a double-blind, randomised, placebo-controlled trial designed to assess the safety and efficacy of a single probiotic strain on symptom severity in adult IBS-D patients, when consumed orally in capsule form once daily for 84 days. Volunteers will be screened in order to identify up to 134 participants meeting ROME IV criteria for IBS-D. The study will involve 5 visits over a total of 105 days [visit 1: screening, commencement of run in period (-21 to -14 days), visit 2: baseline/ randomisation (day 0), visits 3 and 4: intervention period (day 28 ± 2, day 56 ± 2), visit 5: end of study (day 84± 2)]. Participants will fill in daily and weekly eDiaries, and questionnaires will be administered at study visits. Faecal samples will be collected on visits 2 and 5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Diarrhea, Irritable Bowel Syndrome
Keywords
IBS, Probiotic, Irritable Bowel Syndrome, GI microbiome, Bifidobacterium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Arm receiving investigation product (probiotic)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Arm receiving placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Participants in this arm will receive a daily dose of 1x10^10 Colony Forming Unit (CFU) of a single strain probiotic (live bacteria), administered orally by 1 capsule a day, for 84 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Participants in this arm will receive an equivalent placebo for 84 days.
Primary Outcome Measure Information:
Title
Change in total irritable bowel syndrome symptom severity score (IBS-SSS)
Description
Change in IBS-SSS totals score (max 500 points) from baseline to day 28, day 58 and day 84, where higher scores mean worse outcomes
Time Frame
Day 0, Day 28, Day 58 and Day 84
Secondary Outcome Measure Information:
Title
Percentage of population achieving a normal stool consistency
Description
Percentage of the population achieving normal stool consistency, defined as over 75% of total bowel movements classified as stool form type 3, 4, and 5 on Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage at baseline compared to weekly percentage at day 28, 58 and 84.
Time Frame
Day 0, Day 28, Day 58 and Day 84
Title
Percentage of population without diarrhea
Description
Percentage of the population where less than 25% of bowel movements are diarrhea, defined as stool form type 6 or 7 on the Bristol Stool Form Scale (BSFS) (BSFS range: 1-7, lower scores mean constipation, higher scores mean diarrhea). Weekly percentage calculated throughout study and compared to baseline weekly percentage.
Time Frame
Weekly
Title
Change in Irritable Bowel Syndrome Quality of Life (IBS-QOL) score
Description
Change in quality of life, assessed by change in the IBS-QOL total score (max 100 points) between baseline and day 28, day 58 and day 84, where higher scores mean better quality of life
Time Frame
Day 0, Day 28, Day 58 and Day 84
Title
Change in State-Trait Anxiety Inventory for Adults (STAI-AD) score
Description
Mental health as assessed by change in STAI-AD S-anxiety subscale score (max: 80), between baseline and day 28, 58 and 84, where higher scores mean more severe anxiety symptoms
Time Frame
Day 0, Day 28, Day 58 and Day 84
Title
Gut microbiome compositional changes
Description
Change in gut microbiome composition, as assessed by shotgun sequencing of faecal samples, between baseline and study end (day 84)
Time Frame
Day 0, Day 84
Title
Use of Rescue Medication
Description
Comparison in total cumulative use of rescue medications between the two study arms at study end (day 84)
Time Frame
Day 0, Day 84
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Comparison in the total number of adverse events/serious adverse events occurred during the study, from baseline to study end (day 84), between the two study arms
Time Frame
Day 0, Day 84
Title
Stool Biochemistry
Description
Change in stool faecal biochemistry between baseline and study end (day 84) between the two study arms
Time Frame
Day 0, Day 84
Title
Proton Pump Inhibitor Use
Description
Subpopulation analysis: participants taking proton pump inhibitors (PPIs) and participants not taking PPIs compared to placebo at study end
Time Frame
Day 0, Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 movements 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 Test Device. Participants who did not change their diet within three months before the screening day and are willing to sustain that diet during the study. Participants who can comply and perform the procedures as per the protocol (consumption of study products, 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 who score ≥ 40 in either the 'state' or 'trait' section of the STAI-AD questionnaire (both sections to be assessed). Participants diagnosed with Coeliac Disease. Lactose intolerant participants unless on a strict lactose free diet for at least three months before screening day with persistent symptoms of IBS-D. 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, synbiotics, food supplements with iron or calcium, peppermint oil, acid sequestrants (cholestyramine, Bile colestipol), introduced/active low 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 prior to the screening day. Participants with a history of bariatric surgery or surgical resection of the stomach, small intestine, or large intestine. Participants with a history of gastrointestinal-related abdominal surgery other than hernia repair. Participants with a history of or complications from inflammatory bowel disease (Crohn's disease or ulcerative colitis) and ischemic colitis. 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 GI malignant tumours. Participants with a history of or complications from other malignant tumours in the last 5 years. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's endpoints. Participation in other clinical studies in the last 90 days prior to screening day. 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 and other gastrointestinal diseases. Participants with active human immunodeficiency virus (HIV) or hepatitis A, B or C infection. Female participants being pregnant, breastfeeding or planning pregnancy in the course of the study. Any condition that could, in the opinion of the Investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ADM Medical Team
Phone
+44 1460 243 230
Email
medical@protexin.com
Facility Information:
Facility Name
Vizera
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siuka Darko

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of a Probiotic Supplement in IBS-D

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