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CompletedNCT05054309Mood-01Updated Feb 28, 2025

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

An interventional study of Bifidobacterium longum in IBS - Irritable Bowel Syndrome, sponsored by Société des Produits Nestlé (SPN). Completed at 11 sites in Canada. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
146
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • IBS - Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,084 studies on the registry are indexed under Irritable Bowel Syndrome; 196 are open to participants now.

This study's enrollment of 146 is above the median of 70 across 869 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.

Browse Société des Produits Nestlé (SPN) studies →All Nestlé S.A. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
146 participants (actual)

Study arms

  • Active comparator
    Probiotic

    Bifidobacterium longum \[BL NCC3001\]

    Dietary Supplement: Bifidobacterium longum

  • Placebo comparator
    Placebo

    Maltodextrin

    Dietary Supplement: Bifidobacterium longum

Interventions

  • Dietary supplementBifidobacterium longum

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline to 6 weeks.

  2. 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).

    Time frame: Baseline to 6 weeks.

Secondary outcomes

  1. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  2. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  3. 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.

    Time frame: Day -1, Day 43 (± 2 days)

  4. 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.

    Time frame: Day -1, Day 43 (± 2 days)

  5. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  6. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  7. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  8. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  9. 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).

    Time frame: Day -1, Day 43 (± 2 days)

  10. 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.

    Time frame: Day -1, Day 43 (± 2 days)

  11. 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.

    Time frame: Day -1, Day 43 (± 2 days)

  12. 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.

    Time frame: Day -1, Day 43 (± 2 days)

  13. Amount of Bifidobacterium Longum (BL NCC3001) present in stool

    Change from baseline to Week 6

    Time frame: Day -1, Day 43 (± 2 days)

  14. 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.

    Time frame: Day -1, Day 71 (± 2 days)

  15. 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).

    Time frame: Day -1, Day 71 (± 2 days)

  16. Rescue Medication

    Difference in proportions compared to placebo at Week 6

    Time frame: Day 43 (± 2 days)

  17. 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.

    Time frame: Day 43 (± 2 days)

  18. Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"

    Difference in proportions compared to placebo at Week 6

    Time frame: Day 43 (± 2 days)

Other outcomes

  1. Microbiota composition - A subset of 80 subjects (40 per arm)

    Changes in microbiota composition in feces

    Time frame: Day -1, Day 43 (± 2 days), Day 71 (± 2 days)

  2. Microbiota metabolic activity in feces - A subset of 80 subjects (40 per arm)

    Changes in microbiota metabolic activity in feces

    Time frame: Day -1, Day 43 (± 2 days)

  3. Microbiota metabolic activity in blood - A subset of 80 subjects (40 per arm)

    Changes in microbiota metabolic activity in blood

    Time frame: Day -1, Day 43 (± 2 days)

  4. Microbiota metabolic activity in urine - A subset of 80 subjects (40 per arm)

    Changes in microbiota metabolic activity in urine

    Time frame: Day -1, Day 43 (± 2 days)

  5. Cortisol levels in saliva - A subset of 80 subjects (40 per arm)

    Change in cortisol levels in saliva

    Time frame: Day -1, Day 43 (± 2 days)

  6. Biomarkers in blood - A subset of 80 subjects (40 per arm)

    Detection of Biomarkers in blood

    Time frame: Day -1, Day 43 (± 2 days)

  7. Neurotransmitters in blood - A subset of 80 subjects (40 per arm)

    Detection of Neurotransmitters in blood

    Time frame: Day -1, Day 43 (± 2 days)

  8. Amount of Bifidobacterium Longum (BL NCC3001) in stool

    Amount of Bifidobacterium Longum (BL NCC3001) in stool

    Time frame: Day 71 (± 2 days)

07

Study locations

11 sites
  • University of Calgary
    Calgary, Alberta T2N 4Z6, Canada
  • University Of Alberta
    Edmonton, Alberta T6G 2P8, Canada
  • Eastern Regional Health Authority
    St. John's, Newfoundland and Labrador A1B 3V6, Canada
  • Medicor Research Inc.
    Greater Sudbury, Ontario P3C 1X3, Canada
  • McMaster University
    Hamilton, Ontario L8N 3Z5, Canada
  • Scott Shulman Medicine Professional Corporation
    North Bay, Ontario P1B 2H3, Canada
  • The Ottawa Hospital General Campus
    Ottawa, Ontario K1H 8L6, Canada
  • Canadian Phase Onward Inc.
    Toronto, Ontario M3J 0K2, Canada
  • Diex Recherche Quebec Inc.
    Québec, Quebec G1V 4T3, Canada
  • DIEX Recherche
    Saint-Charles-Borromée, Quebec J6E 2B4, Canada
  • PerCuro Clinical Research Ltd.
    Victoria, V8V 3M9, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2022 to primary completion in Dec 2024, 33 months.

Of 48 industry-sponsored interventional studies with no phase under Irritable Bowel Syndrome, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 29. This study's 33 months is above that.

Counting every sponsor, half of 345 studies reached it within 19 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 14, 2021
First posted
Sep 23, 2021
StartActual
Feb 11, 2022
Primary completionActual
Dec 4, 2024
CompletionActual
Feb 14, 2025
Last update
Feb 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05054309
Lead sponsor
Société des Produits Nestlé (SPN)
Collaborators
Syneos Health, Medidata Solutions, McMaster University, CaligorRx, Inc.
Responsible party
Sponsor
First posted
Sep 23, 2021
Start date
Feb 11, 2022
Primary completion
Dec 4, 2024
Completion
Feb 14, 2025
Last update
Feb 28, 2025

Study contacts

Premsyl Bercik, MD
principal investigator · McMaster University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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