IBS - Irritable Bowel SyndromeMood-01NCT05054309
A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
A study testing Bifidobacterium longum in people with IBS - Irritable Bowel Syndrome, run by Société des Produits Nestlé (SPN) at 11 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Bifidobacterium longum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 11 sitesCanada
- Study dates
- 11 Feb 2022to 14 Feb 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 19Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Canada11 sites
University of Calgary
Calgary, Alberta, T2N 4Z6
University Of Alberta
Edmonton, Alberta, T6G 2P8
Medicor Research Inc.
Greater Sudbury, Ontario, P3C 1X3
McMaster University
Hamilton, Ontario, L8N 3Z5
Scott Shulman Medicine Professional Corporation
North Bay, Ontario, P1B 2H3
The Ottawa Hospital General Campus
Ottawa, Ontario, K1H 8L6
Diex Recherche Quebec Inc.
Québec, Quebec, G1V 4T3
DIEX Recherche
Saint-Charles-Borromée, Quebec, J6E 2B4
Eastern Regional Health Authority
St. John's, Newfoundland and Labrador, A1B 3V6
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
PerCuro Clinical Research Ltd.
Victoria, V8V 3M9
About this study
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
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.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Bifidobacterium longum
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longumDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Bifidobacterium longum [BL NCC3001] Receives: Dietary Supplement: Bifidobacterium longum |
| Placebo | Placebo comparator | Maltodextrin Receives: Dietary Supplement: Bifidobacterium longum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 weeks.
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).
Measured: Baseline to 6 weeks.
Secondary outcomes (18)
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).
Measured: Day -1, Day 43 (± 2 days)
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).
Measured: Day -1, Day 43 (± 2 days)
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.
Measured: Day -1, Day 43 (± 2 days)
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.
Measured: Day -1, Day 43 (± 2 days)
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).
Measured: Day -1, Day 43 (± 2 days)
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).
Measured: Day -1, Day 43 (± 2 days)
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).
Measured: Day -1, Day 43 (± 2 days)
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).
Measured: Day -1, Day 43 (± 2 days)
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).
Measured: Day -1, Day 43 (± 2 days)
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.
Measured: Day -1, Day 43 (± 2 days)
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.
Measured: Day -1, Day 43 (± 2 days)
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.
Measured: Day -1, Day 43 (± 2 days)
Amount of Bifidobacterium Longum (BL NCC3001) present in stool
Change from baseline to Week 6
Measured: Day -1, Day 43 (± 2 days)
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.
Measured: Day -1, Day 71 (± 2 days)
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).
Measured: Day -1, Day 71 (± 2 days)
Rescue Medication
Difference in proportions compared to placebo at Week 6
Measured: Day 43 (± 2 days)
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.
Measured: Day 43 (± 2 days)
Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"
Difference in proportions compared to placebo at Week 6
Measured: Day 43 (± 2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2021
- Study start11 Feb 2022
- Primary completion4 Dec 2024
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Medidata Solutions, McMaster University, CaligorRx, Inc.
- Responsible party
- Sponsor
- Investigators
- Premsyl Bercik, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05054309
- Sponsor's protocol ID
- 20.01.CLI
- Acronym
- Mood-01
- Status last verified
- Feb 2025
- First submitted
- 14 Sep 2021
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05054309
- Acronym / sponsor ID
- Mood-01 / 20.01.CLI
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Medidata Solutions, McMaster University, CaligorRx, Inc.
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 23 Sep 2021 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Bifidobacterium longumBifidobacterium longum [BL NCC3001] |
| Placebo | Placebo comparator | Dietary Supplement: Bifidobacterium longumMaltodextrin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| Bifidobacterium longumA 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 | Dietary supplement | Placebo, Probiotic |
Primary outcome
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms
Time frame: Baseline to 6 weeks.
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
Time frame: Baseline to 6 weeks.
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).
18 secondary outcomes
Hospital Anxiety Depression Scale - Depression (HADS-D) score
Time frame: Day -1, Day 43 (± 2 days)
Hospital Anxiety Depression Scale - Anxiety (HADS-A) score
Time frame: Day -1, Day 43 (± 2 days)
Depression Anxiety Stress Scale (DASS-21)
Time frame: Day -1, Day 43 (± 2 days)
Perceived Stress Scale (PSS)
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Severity Scoring System (IBS-SSS) Pain severity
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Severity Scoring System (IBS-SSS) Pain frequency
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Severity Scoring System (IBS-SSS) Bloating severity
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Severity Scoring System (IBS-SSS) Bowel habit
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Severity Scoring System (IBS-SSS) Life impact
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Syndrome Quality of Life questionnaire (IBS-QoL)
Time frame: Day -1, Day 43 (± 2 days)
Patient Health Questionnaire (PHQ-12)
Time frame: Day -1, Day 43 (± 2 days)
Sheehan Disability Scale (SDS)
Time frame: Day -1, Day 43 (± 2 days)
Amount of Bifidobacterium Longum (BL NCC3001) present in stool
Time frame: Day -1, Day 43 (± 2 days)
Irritable Bowel Severity Scoring System (IBS-SSS) score
Time frame: Day -1, Day 71 (± 2 days)
Hospital Anxiety Depression Scale (HADS) total score
Time frame: Day -1, Day 71 (± 2 days)
Rescue Medication
Time frame: Day 43 (± 2 days)
Psychological distress improvement according to the Patient's Global Impression of Change of "Psychological Distress"
Time frame: Day 43 (± 2 days)
Active treatment randomization perception: "Do you think you have taken the placebo or active treatment?"
Time frame: Day 43 (± 2 days)
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 28 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Premsyl Bercik, MD principal investigator
McMaster University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum in people with IBS - Irritable Bowel Syndrome, run by Société des Produits Nestlé (SPN) at 11 sites in Canada.
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 5 inclusion and 19 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada. 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?
To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms (time frame: Baseline to 6 weeks.). The study lists 2 primary outcomes in all. 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 28 Feb 2025.