Irritable Bowel SyndromePhase 1/2NCT01276626
Study of Bacteria on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome
A Phase 1/2 study testing Bifidobacterium longum and Maltodextrin in people with Irritable Bowel Syndrome and IBS, run by Société des Produits Nestlé (SPN) at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome, IBS
- What is being tested?
- Bifidobacterium longum and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Jun 2014
- Phase
- Phase 1/2
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Irritable Bowel Syndrome based on Rome III Criteria
- Symptoms of mild to moderate anxiety and depression
Who cannot join
- Concurrent systemic disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
- Concurrent organic Gastrointestinal (GI) pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli.
- Psychiatric diagnosis other than anxiety or depression.
- Patients treated with therapeutic/standard doses of antidepressants and/or anxiolytics
- History of active cancer in the last 5 years, other than skin basal cells cancer
- Pregnant or breastfeeding women
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- Treatment with antibiotics during the three months prior the study.
- Known or suspected allergies to the study products (eg maltodextrin).
- Patients who have heart pacemakers, metal implants, metal chips or clips in or around the eyeballs, artificial heart valves, metallic ear implants, bullet fragments or fixed brackets.
- High fiber diet (>35 g/day for males, > 25 g/day for females), consumption of high inulin containing foods (>5 g/day).
- Consumption of any type of yoghurts or probiotic-containing products in the 4 weeks prior to the beginning of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).
The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.
- Conditions
- Irritable Bowel Syndrome, IBS
- Being tested
- Bifidobacterium longum, Maltodextrin
- 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
Powder containing Bifidobacterium longum in maltodextrin.
MaltodextrinOther
Powder containing only maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Bifidobacterium longum | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium longum |
| Maltodextrin | Placebo comparator | Not described Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression (HAD) scale.
Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.
Measured: 6 weeks post-treatment initiation
Secondary outcomes (2)
Improvement in IBS symptoms.
Measured: 6 and 10 weeks post-treatment
Improvement in objective biomarkers.
Measured: 6 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Responsible party
- Sponsor
- Investigators
- Peter McLean, PhD, Study director, Société des Produits Nestlé (SPN)Premysl Bercik, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01276626
- Sponsor's protocol ID
- Nestle 09.25.NRC
- Status last verified
- Aug 2014
- First submitted
- 27 Dec 2010
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pinto-Sanchez MI, Hall GB, Ghajar K, Nardelli A, Bolino C, Lau JT, Martin FP, Cominetti O, Welsh C, Rieder A, Traynor J, Gregory C, De Palma G, Pigrau M, Ford AC, Macri J, Berger B, Bergonzelli G, Surette MG, Collins SM, Moayyedi P, Bercik P. Probiotic Bifidobacterium longum NCC3001 Reduces Depression Scores and Alters Brain Activity: A Pilot Study in Patients With Irritable Bowel Syndrome. Gastroenterology. 2017 Aug;153(2):448-459.e8. doi: 10.1053/j.gastro.2017.05.003. Epub 2017 May 5.
PubMed 28483500
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Probiotic Bifidobacterium Longum (B. Longum) on Mood and Bowel Symptoms in Patients With Irritable Bowel Syndrome (IBS).
- ClinicalTrials.gov ID
- NCT01276626
- Acronym / sponsor ID
- Nestle 09.25.NRC
- Conditions
- Irritable Bowel Syndrome, IBS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- McMaster University
- Study start
- Jan 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 13 Jan 2011 (estimated)
- 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.
The purpose of this study is to determine whether probiotic bacterium Bifidobacterium longum (B. longum) can improve mood and bowel symptoms in patients with Irritable bowel syndrome (IBS). The patients will be treated with probiotic or placebo for 6 weeks. Their mood, memory, general well-being and bowel symptoms will be assessed before, at the end of the treatment and 4 weeks later. Brain activation pattern, changes in gut bacteria, metabolic profile and inflammatory markers will be also measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bifidobacterium longum | Experimental | Dietary Supplement: Bifidobacterium longum |
| Maltodextrin | Placebo comparator | Other: Maltodextrin |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of Irritable Bowel Syndrome based on Rome III Criteria
- Symptoms of mild to moderate anxiety and depression
Key exclusion criteria (11 listed)
- Concurrent systemic disease and/or laboratory abnormalities considered by Investigators to be risky or that could interfere with data collection.
- Concurrent organic Gastrointestinal (GI) pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas and melanosis coli.
- Psychiatric diagnosis other than anxiety or depression.
- Patients treated with therapeutic/standard doses of antidepressants and/or anxiolytics
- History of active cancer in the last 5 years, other than skin basal cells cancer
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 longumPowder containing Bifidobacterium longum in maltodextrin. | Dietary supplement | Bifidobacterium longum |
| MaltodextrinPowder containing only maltodextrin | Other | Maltodextrin |
Primary outcome
Hospital Anxiety and Depression (HAD) scale.
Time frame: 6 weeks post-treatment initiation
Change in anxiety and depression, assessed using Hospital Anxiety and Depression (HAD) scale, after six weeks of treatment.
2 secondary outcomes
Improvement in IBS symptoms.
Time frame: 6 and 10 weeks post-treatment
Improvement in objective biomarkers.
Time frame: 6 weeks post-treatment
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 5 Aug 2014.
- Derived from this study: PubMed 28483500Pinto-Sanchez MI, Hall GB, Ghajar K, Nardelli A, Bolino C, Lau JT, Martin FP, Cominetti O, Welsh C, Rieder A, Traynor J, Gregory C, De Palma G, Pigrau M, Ford AC, Macri J, Berger B, Bergonzelli G, Surette MG, Collins SM, Moayyedi P, Bercik P. Probiotic Bifidobacterium longum NCC3001 Reduces Depression Scores and Alters Brain Activity: A Pilot Study in Patients With Irritable Bowel Syndrome. Gastroenterology. 2017 Aug;153(2):448-459.e8. doi: 10.1053/j.gastro.2017.05.003. Epub 2017 May 5.
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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.
Peter McLean, PhD study director
Société des Produits Nestlé (SPN)
Premysl Bercik, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bifidobacterium longum and Maltodextrin in people with Irritable Bowel Syndrome and IBS, run by Société des Produits Nestlé (SPN) at 1 site 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 2 inclusion and 11 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hospital Anxiety and Depression (HAD) scale. (time frame: 6 weeks post-treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01276626, which also lists 1 linked publication.
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 5 Aug 2014.