Clinical trial NCT05054309: A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
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
Overall status: COMPLETED
Phase: NA
Conditions: IBS - Irritable Bowel Syndrome
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
name: Medidata Solutions
name: McMaster University
name: CaligorRx, Inc.
First posted: 2021-09-23
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms
timeFrame: Baseline to 6 weeks.
measure: To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Psychological Symptoms
timeFrame: Baseline to 6 weeks.
Secondary outcomes:
measure: Hospital Anxiety Depression Scale - Depression (HADS-D) score
timeFrame: Day -1, Day 43 (± 2 days)
measure: Hospital Anxiety Depression Scale - Anxiety (HADS-A) score
timeFrame: Day -1, Day 43 (± 2 days)
measure: Depression Anxiety Stress Scale (DASS-21)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Perceived Stress Scale (PSS)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Severity Scoring System (IBS-SSS) Pain severity
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Severity Scoring System (IBS-SSS) Pain frequency
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Severity Scoring System (IBS-SSS) Bloating severity
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Severity Scoring System (IBS-SSS) Bowel habit
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Severity Scoring System (IBS-SSS) Life impact
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Patient Health Questionnaire (PHQ-12)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Sheehan Disability Scale (SDS)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Amount of Bifidobacterium Longum (BL NCC3001) present in stool
timeFrame: Day -1, Day 43 (± 2 days)
measure: Irritable Bowel Severity Scoring System (IBS-SSS) score
timeFrame: Day -1, Day 71 (± 2 days)
measure: Hospital Anxiety Depression Scale (HADS) total score
timeFrame: Day -1, Day 71 (± 2 days)
measure: Rescue Medication
timeFrame: Day 43 (± 2 days)
measure: Psychological distress improvement according to the Patient's Global Impression of Change of "Psychological Distress"
timeFrame: Day 43 (± 2 days)
measure: Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"
timeFrame: Day 43 (± 2 days)
Other outcomes:
measure: Microbiota composition - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days), Day 71 (± 2 days)
measure: Microbiota metabolic activity in feces - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Microbiota metabolic activity in blood - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Microbiota metabolic activity in urine - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Cortisol levels in saliva - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Biomarkers in blood - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Neurotransmitters in blood - A subset of 80 subjects (40 per arm)
timeFrame: Day -1, Day 43 (± 2 days)
measure: Amount of Bifidobacterium Longum (BL NCC3001) in stool
timeFrame: Day 71 (± 2 days)
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: University Of Alberta
state: Alberta
city: Saint John's
country: Canada
facility: Eastern Regional Health Authority
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: North Bay
country: Canada
facility: Scott Shulman Medicine Professional Corporation
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital General Campus
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Canadian Phase Onward Inc.
state: Ontario
city: Québec
country: Canada
facility: Diex Recherche Quebec Inc.
state: Quebec
city: Saint Charles Borromee
country: Canada
facility: DIEX Recherche
state: Quebec
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
Study officials:
affiliation: McMaster University
name: Premsyl Bercik, MD
role: PRINCIPAL_INVESTIGATOR
References: