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A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome (Mood-01)

Primary Purpose

IBS - Irritable Bowel Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Bifidobacterium longum
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for IBS - Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female, age between 18 and 70 years inclusive.
  2. Willing and able to sign written informed consent prior to study entry.
  3. Able to comply with the study procedures, in the opinion of the investigator.
  4. Subjects diagnosed with IBS. All subtypes based on Rome IV Criteria with active IBS symptoms as indicated by a score of ≥ 125 on the IBS-SSS.
  5. Subjects with psychological symptoms in the absence of a psychiatric diagnosis, defined as a score of 5 to 13 in the depression domain and/or a score of 4 to 9 in the anxiety domain of the DASS-21 questionnaire.

Exclusion Criteria:

  1. Concurrent formal diagnosis by a psychiatric specialist, including any mood or anxiety disorder, according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th or 5th edition.
  2. Concurrent systemic disease and/ or laboratory abnormalities considered by the investigator to be clinically relevant or that could interfere with data collection or interpretation.
  3. Concurrent organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas, and melanosis coli.
  4. History of attempted suicide in the past 5 years.
  5. Previous abdominal surgery except for hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, and hemorrhoidectomy.
  6. History of substance abuse in the past 2 years, including opiates, phencyclidine, benzodiazepines, amphetamines, cocaine, heroin, alcohol, and cannabinoids (except if medically indicated).
  7. Subjects who are on daily treatment with therapeutic doses of drugs having central nervous system effects, including antidepressants and/ or anxiolytics. Low doses of (I) tricyclic antidepressants for abdominal pain/diarrhea related to IBS and (II) anxiolytics used as sleeping pills will be permitted if dose is stable > 3 months prior to the date of randomization.
  8. Pregnant or breastfeeding women.
  9. Subjects with dementia or other cognitive impairment.
  10. Subjects who received antibiotics within the 4 weeks prior to the date of randomization .
  11. Known or suspected allergies to the study products.
  12. Subjects with increased risk of probiotic sepsis as the following conditions: Immune compromise, including debilitating state or malignancy, central venous catheter, impaired intestinal epithelial barrier (acute diarrheal illness, intestinal inflammation, etc.), cardiac valvular disease.
  13. Subjects currently participating or having participated in a therapeutic trial within 3 months prior to the date of randomization.
  14. Medically diagnosed lactose intolerance and fructose intolerance without being on a stable lactose or fructose free diet (> 3 months prior to the date of randomization).
  15. Medically diagnosed celiac disease.
  16. Consumption of any probiotic supplements specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Bacillus coagulans, and Saccharomyces at least 2 weeks prior to the date of randomization.
  17. Subjects on regular use of drugs to control IBS symptoms such as bile acid binders (cholestyramine, colestipol or colesevelam, rifaximin, alosetron, lubiprostone, eluxadoline and linaclotide).
  18. Recently initiated exclusion diets. Subjects on stable exclusion diets (> 3 months prior to the date of randomization) will not be excluded. This includes subjects with the following diets: gluten-free, lactose-free, paleo, vegetarian, vegan, and low-carbohydrate.
  19. Low-FODMAP diet. Subjects on the induction phase of the FODMAP exclusion will not be enrolled. Subjects on the maintenance phase of the diet for more than 3 months prior to the date of randomization with stable diet can be considered for enrollment.

Sites / Locations

  • University of CalgaryRecruiting
  • University Of AlbertaRecruiting
  • Eastern Regional Health AuthorityRecruiting
  • Viable Clinical Research Corporation
  • McMaster UniversityRecruiting
  • Scott Shulman Medicine Professional CorporationRecruiting
  • Medicor Research Inc.Recruiting
  • Canadian Phase Onward Inc.Recruiting
  • Diex Recherche Quebec Inc.Recruiting
  • DIEX RechercheRecruiting
  • PerCuro Clinical Research Ltd.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Bifidobacterium longum [BL NCC3001]

Maltodextrin

Outcomes

Primary Outcome Measures

To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms
Change from baseline to week 6 in Irritable Bowel Severity Scoring System (IBS-SSS), a questionnaire that includes 5 questions related to the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. This cumulative score can therefore range from 0 to 500, with higher scores indicating more severe symptoms.
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Psychological Symptoms
Change from baseline to week 6 in Hospital Anxiety and Depression Scale (HADS-Total) score, a 14-item scale assessing two dimensions (anxiety and depression, 7 items for each) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21), depression score (0-21) and the total score (0-42).

Secondary Outcome Measures

Hospital Anxiety Depression Scale - Depression (HADS-D) score
Change from baseline to Week 6 in Hospital Anxiety Depression Scale-Depression (HADS-D) score, a 14-item scale assessing depression (7 items) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the depression score (0-21).
Hospital Anxiety Depression Scale - Anxiety (HADS-A) score
Change from baseline to Week 6 in Hospital Anxiety Depression Scale-Anxiety (HADS-A) score, a 14-item scale assessing anxiety (7 items) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21).
Depression Anxiety Stress Scale (DASS-21)
Change from baseline to Week 6 in Depression Anxiety Stress Scale (DASS-21), a four-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much" or "most of the time"). The outcome measures correspond to the total scores (0-21) of the subscales.
Perceived Stress Scale (PSS)
Change from baseline to Week 6 in Perceived Stress Scale (PSS), includes several direct queries about current levels of experienced stress, each item is rated on a Likert scale (0-4), the range of the total score is 0-40.
Irritable Bowel Severity Scoring System (IBS-SSS) Pain severity
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) pain severity, a question related to the severity of abdominal pain over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Irritable Bowel Severity Scoring System (IBS-SSS) Pain frequency
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) pain frequency, a question related to the frequency of abdominal pain over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Irritable Bowel Severity Scoring System (IBS-SSS) Bloating severity
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) bloating severity, a question related to the severity of abdominal distention over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Irritable Bowel Severity Scoring System (IBS-SSS) Bowel habit
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) bowel habit, a question related to dissatisfaction with bowel habits over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Irritable Bowel Severity Scoring System (IBS-SSS) Life impact
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) life impact, a question related to interference with quality of life over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL)
Change from baseline to Week 6 in Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL), a 34-item, validated, condition-specific measure based on 5-point Likert scale for assessing health-related quality of life in the past month among persons with IBS.
Patient Health Questionnaire (PHQ-12)
Change from baseline to Week 6 in Patient Health Questionnaire (PHQ-12), each somatic symptom is evaluated in a Likert scale from 0 to 2 (not bothered at all, bothered a little and bothered a lot) giving a maximum total of 24 points.
Sheehan Disability Scale (SDS)
Change from baseline to Week 6 in Sheehan Disability Scale (SDS), the patients rates the extent to which work/school, social and family life are impaired by his/her symptoms on a 10-point VAS.
Amount of Bifidobacterium Longum (BL NCC3001) present in stool
Change from baseline to Week 6
Irritable Bowel Severity Scoring System (IBS-SSS) score
Change from baseline to Week 10 in Irritable Bowel Severity Scoring System (IBS-SSS) score, a cumulative score which can therefore range from 0 to 500, with higher scores indicating more severe symptoms. Mild, moderate, and severe cases are indicated by scores of 75 to 175.
Hospital Anxiety Depression Scale (HADS) total score
Change from baseline to Week 10 in Hospital Anxiety Depression Scale (HADS) total score, a 14-item scale assessing two dimensions (anxiety and depression, 7 items for each) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21), depression score (0-21) and the total score (0-42).
Rescue Medication
Difference in proportions compared to placebo at Week 6
Psychological distress improvement according to the Patient's Global Impression of Change of "Psychological Distress"
Difference in proportions compared to placebo at Week 6 using a 7-point Likert scale depicting a patient's rating of overall improvement of the psychological distress since the beginning of treatment. The range of the score is 1 to 7.
Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"
Difference in proportions compared to placebo at Week 6

Full Information

First Posted
September 14, 2021
Last Updated
August 29, 2023
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT05054309
Brief Title
A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
Acronym
Mood-01
Official Title
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

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

5. Study Description

Brief Summary
This is a prospective, randomized, placebo-controlled, double-blind, multi-center parallel- design study to evaluate the effect of BL NCC3001 in subjects with Irritable Bowel Syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Bifidobacterium longum [BL NCC3001]
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Bifidobacterium longum
Intervention Description
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
Primary Outcome Measure Information:
Title
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms
Description
Change from baseline to week 6 in Irritable Bowel Severity Scoring System (IBS-SSS), a questionnaire that includes 5 questions related to the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. This cumulative score can therefore range from 0 to 500, with higher scores indicating more severe symptoms.
Time Frame
Baseline to 6 weeks.
Title
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Psychological Symptoms
Description
Change from baseline to week 6 in Hospital Anxiety and Depression Scale (HADS-Total) score, a 14-item scale assessing two dimensions (anxiety and depression, 7 items for each) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21), depression score (0-21) and the total score (0-42).
Time Frame
Baseline to 6 weeks.
Secondary Outcome Measure Information:
Title
Hospital Anxiety Depression Scale - Depression (HADS-D) score
Description
Change from baseline to Week 6 in Hospital Anxiety Depression Scale-Depression (HADS-D) score, a 14-item scale assessing depression (7 items) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the depression score (0-21).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Hospital Anxiety Depression Scale - Anxiety (HADS-A) score
Description
Change from baseline to Week 6 in Hospital Anxiety Depression Scale-Anxiety (HADS-A) score, a 14-item scale assessing anxiety (7 items) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Depression Anxiety Stress Scale (DASS-21)
Description
Change from baseline to Week 6 in Depression Anxiety Stress Scale (DASS-21), a four-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much" or "most of the time"). The outcome measures correspond to the total scores (0-21) of the subscales.
Time Frame
Day -1, Day 43 (± 2 days)
Title
Perceived Stress Scale (PSS)
Description
Change from baseline to Week 6 in Perceived Stress Scale (PSS), includes several direct queries about current levels of experienced stress, each item is rated on a Likert scale (0-4), the range of the total score is 0-40.
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Severity Scoring System (IBS-SSS) Pain severity
Description
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) pain severity, a question related to the severity of abdominal pain over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Severity Scoring System (IBS-SSS) Pain frequency
Description
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) pain frequency, a question related to the frequency of abdominal pain over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Severity Scoring System (IBS-SSS) Bloating severity
Description
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) bloating severity, a question related to the severity of abdominal distention over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Severity Scoring System (IBS-SSS) Bowel habit
Description
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) bowel habit, a question related to dissatisfaction with bowel habits over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Severity Scoring System (IBS-SSS) Life impact
Description
Change from baseline to Week 6 in Irritable Bowel Severity Scoring System (IBS-SSS) life impact, a question related to interference with quality of life over the past 10 days. The question is scored on a 100-point visual analogue scale, which is anchored with the 2 extremes (e.g., no pain on the far left to severe pain on the far right).
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL)
Description
Change from baseline to Week 6 in Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL), a 34-item, validated, condition-specific measure based on 5-point Likert scale for assessing health-related quality of life in the past month among persons with IBS.
Time Frame
Day -1, Day 43 (± 2 days)
Title
Patient Health Questionnaire (PHQ-12)
Description
Change from baseline to Week 6 in Patient Health Questionnaire (PHQ-12), each somatic symptom is evaluated in a Likert scale from 0 to 2 (not bothered at all, bothered a little and bothered a lot) giving a maximum total of 24 points.
Time Frame
Day -1, Day 43 (± 2 days)
Title
Sheehan Disability Scale (SDS)
Description
Change from baseline to Week 6 in Sheehan Disability Scale (SDS), the patients rates the extent to which work/school, social and family life are impaired by his/her symptoms on a 10-point VAS.
Time Frame
Day -1, Day 43 (± 2 days)
Title
Amount of Bifidobacterium Longum (BL NCC3001) present in stool
Description
Change from baseline to Week 6
Time Frame
Day -1, Day 43 (± 2 days)
Title
Irritable Bowel Severity Scoring System (IBS-SSS) score
Description
Change from baseline to Week 10 in Irritable Bowel Severity Scoring System (IBS-SSS) score, a cumulative score which can therefore range from 0 to 500, with higher scores indicating more severe symptoms. Mild, moderate, and severe cases are indicated by scores of 75 to 175.
Time Frame
Day -1, Day 71 (± 2 days)
Title
Hospital Anxiety Depression Scale (HADS) total score
Description
Change from baseline to Week 10 in Hospital Anxiety Depression Scale (HADS) total score, a 14-item scale assessing two dimensions (anxiety and depression, 7 items for each) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21), depression score (0-21) and the total score (0-42).
Time Frame
Day -1, Day 71 (± 2 days)
Title
Rescue Medication
Description
Difference in proportions compared to placebo at Week 6
Time Frame
Day 43 (± 2 days)
Title
Psychological distress improvement according to the Patient's Global Impression of Change of "Psychological Distress"
Description
Difference in proportions compared to placebo at Week 6 using a 7-point Likert scale depicting a patient's rating of overall improvement of the psychological distress since the beginning of treatment. The range of the score is 1 to 7.
Time Frame
Day 43 (± 2 days)
Title
Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"
Description
Difference in proportions compared to placebo at Week 6
Time Frame
Day 43 (± 2 days)
Other Pre-specified Outcome Measures:
Title
Microbiota composition - A subset of 80 subjects (40 per arm)
Description
Changes in microbiota composition in feces
Time Frame
Day -1, Day 43 (± 2 days), Day 71 (± 2 days)
Title
Microbiota metabolic activity in feces - A subset of 80 subjects (40 per arm)
Description
Changes in microbiota metabolic activity in feces
Time Frame
Day -1, Day 43 (± 2 days)
Title
Microbiota metabolic activity in blood - A subset of 80 subjects (40 per arm)
Description
Changes in microbiota metabolic activity in blood
Time Frame
Day -1, Day 43 (± 2 days)
Title
Microbiota metabolic activity in urine - A subset of 80 subjects (40 per arm)
Description
Changes in microbiota metabolic activity in urine
Time Frame
Day -1, Day 43 (± 2 days)
Title
Cortisol levels in saliva - A subset of 80 subjects (40 per arm)
Description
Change in cortisol levels in saliva
Time Frame
Day -1, Day 43 (± 2 days)
Title
Biomarkers in blood - A subset of 80 subjects (40 per arm)
Description
Detection of Biomarkers in blood
Time Frame
Day -1, Day 43 (± 2 days)
Title
Neurotransmitters in blood - A subset of 80 subjects (40 per arm)
Description
Detection of Neurotransmitters in blood
Time Frame
Day -1, Day 43 (± 2 days)
Title
Amount of Bifidobacterium Longum (BL NCC3001) in stool
Description
Amount of Bifidobacterium Longum (BL NCC3001) in stool
Time Frame
Day 71 (± 2 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, age between 18 and 70 years inclusive. Willing and able to sign written informed consent prior to study entry. Able to comply with the study procedures, in the opinion of the investigator. Subjects diagnosed with IBS. All subtypes based on Rome IV Criteria with active IBS symptoms as indicated by a score of ≥ 125 on the IBS-SSS. Subjects with psychological symptoms in the absence of a psychiatric diagnosis, defined as a score of 5 to 13 in the depression domain and/or a score of 4 to 9 in the anxiety domain of the DASS-21 questionnaire. Exclusion Criteria: Concurrent formal diagnosis by a psychiatric specialist, including any mood or anxiety disorder, according to the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th or 5th edition. Concurrent systemic disease and/ or laboratory abnormalities considered by the investigator to be clinically relevant or that could interfere with data collection or interpretation. Concurrent organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas, and melanosis coli. History of attempted suicide in the past 5 years. Previous abdominal surgery except for hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, and hemorrhoidectomy. History of substance abuse in the past 2 years, including opiates, phencyclidine, benzodiazepines, amphetamines, cocaine, heroin, alcohol, and cannabinoids (except if medically indicated). Subjects who are on daily treatment with therapeutic doses of drugs having central nervous system effects, including antidepressants and/ or anxiolytics. Low doses of (I) tricyclic antidepressants for abdominal pain/diarrhea related to IBS and (II) anxiolytics used as sleeping pills will be permitted if dose is stable > 3 months prior to the date of randomization. Pregnant or breastfeeding women. Subjects with dementia or other cognitive impairment. Subjects who received antibiotics within the 4 weeks prior to the date of randomization . Known or suspected allergies to the study products. Subjects with increased risk of probiotic sepsis as the following conditions: Immune compromise, including debilitating state or malignancy, central venous catheter, impaired intestinal epithelial barrier (acute diarrheal illness, intestinal inflammation, etc.), cardiac valvular disease. Subjects currently participating or having participated in a therapeutic trial within 3 months prior to the date of randomization. Medically diagnosed lactose intolerance and fructose intolerance without being on a stable lactose or fructose free diet (> 3 months prior to the date of randomization). Medically diagnosed celiac disease. Consumption of any probiotic supplements specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Bacillus coagulans, and Saccharomyces at least 2 weeks prior to the date of randomization. Subjects on regular use of drugs to control IBS symptoms such as bile acid binders (cholestyramine, colestipol or colesevelam, rifaximin, alosetron, lubiprostone, eluxadoline and linaclotide). Recently initiated exclusion diets. Subjects on stable exclusion diets (> 3 months prior to the date of randomization) will not be excluded. This includes subjects with the following diets: gluten-free, lactose-free, paleo, vegetarian, vegan, and low-carbohydrate. Low-FODMAP diet. Subjects on the induction phase of the FODMAP exclusion will not be enrolled. Subjects on the maintenance phase of the diet for more than 3 months prior to the date of randomization with stable diet can be considered for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Hauffe
Phone
4083550568
Email
mhauffe@aimmune.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Premsyl Bercik, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Name
University Of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Eastern Regional Health Authority
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Viable Clinical Research Corporation
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B2W 6L4
Country
Canada
Individual Site Status
Withdrawn
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Nardelli
Facility Name
Scott Shulman Medicine Professional Corporation
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 2H3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katie Argo
Phone
705-476-7737
Email
katiejargo@gmail.com
First Name & Middle Initial & Last Name & Degree
Kelsey Secord
Phone
705-476-7737
Email
kelseysecord@gmail.com
First Name & Middle Initial & Last Name & Degree
Scott Shulman
Facility Name
Medicor Research Inc.
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 1X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexus McCue
Phone
705-566-0005
Email
alexus.mccue@medicorresearch.com
First Name & Middle Initial & Last Name & Degree
Jessica Richer
Phone
705-566-0005
Email
jessica.richer@medicorresearch.com
First Name & Middle Initial & Last Name & Degree
Heather Boudreau
Facility Name
Canadian Phase Onward Inc.
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 0K2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afa Melik
Facility Name
Diex Recherche Quebec Inc.
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa Tardif
Facility Name
DIEX Recherche
City
Saint Charles Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Individual Site Status
Recruiting
Facility Name
PerCuro Clinical Research Ltd.
City
Victoria
ZIP/Postal Code
V8V 3M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joyce Bendall

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome

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