Probiotic for Irritable Bowel Syndrome

(Mood-01 Trial)

No longer recruiting at 13 trial locations

Overseen By Andrea Nardelli

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Société des Produits Nestlé (SPN)

Must not be taking: Antidepressants, Anxiolytics

Disqualifiers: Psychiatric diagnosis, Substance abuse, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the probiotic Bifidobacterium longum NCC3001 helps individuals with Irritable Bowel Syndrome (IBS). The researchers will compare the probiotic to a placebo (a substance with no active ingredients) to assess its effectiveness in relieving IBS symptoms. Participants must have an IBS diagnosis, with ongoing symptoms impacting their daily life. This trial may suit those experiencing regular IBS symptoms and mild psychological symptoms, but without a formal psychiatric diagnosis. As an unphased trial, it offers an opportunity to contribute to understanding the potential benefits of probiotics for IBS.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop taking certain medications. You cannot be on daily treatment with drugs affecting the central nervous system, like antidepressants or anxiolytics, unless they are low doses for IBS-related symptoms and have been stable for over 3 months. You also cannot use drugs to control IBS symptoms like bile acid binders or certain other medications. If you're on these medications, you may need to stop or adjust them before participating.

Will I have to stop taking my current medications?

You may need to stop certain medications, especially if they are used to control IBS symptoms or have central nervous system effects like antidepressants or anxiolytics. However, low doses of some medications for IBS-related pain or sleep issues are allowed if the dose has been stable for over 3 months.

Is there any evidence suggesting that Bifidobacterium longum NCC3001 is likely to be safe for humans?

Research has shown that Bifidobacterium longum NCC3001, a type of probiotic, is generally safe and well-tolerated. Various studies, including those on similar strains like Bifidobacterium longum 35624, found that this probiotic helps alleviate irritable bowel syndrome (IBS) symptoms without causing serious side effects.

A review of 46 studies found that probiotics, including those related to Bifidobacterium longum, are safe for IBS patients. Most people experienced only mild issues, such as gas or bloating, which are common with many probiotics.

These studies reported no major safety concerns, suggesting that Bifidobacterium longum NCC3001 is likely safe for use in IBS. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Irritable Bowel Syndrome?

Unlike the standard treatments for irritable bowel syndrome (IBS), which often include antispasmodics, laxatives, and dietary changes, Bifidobacterium longum NCC3001 is a probiotic that offers a unique approach. This probiotic works by potentially restoring the balance of good bacteria in the gut, which can help improve digestive health and reduce IBS symptoms. Researchers are excited because this could mean a natural, gut-friendly alternative that targets the underlying gut microbiota imbalance, offering hope for those seeking relief without the side effects common in traditional medications.

What evidence suggests that Bifidobacterium longum NCC3001 might be an effective treatment for Irritable Bowel Syndrome?

Research has shown that Bifidobacterium longum NCC3001, which participants in this trial may receive, might help people with Irritable Bowel Syndrome (IBS). One study found that this probiotic reduced depression and improved the quality of life for IBS patients. Another study found that a similar strain, Bifidobacterium longum 35624, significantly relieved symptoms in just 8 weeks. Additionally, patients taking Bifidobacterium longum 35624 reported less severe IBS symptoms after 30 days of treatment. These findings suggest that Bifidobacterium longum NCC3001 could help ease some IBS symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Premsyl Bercik, MD

Principal Investigator

McMaster University

Are You a Good Fit for This Trial?

Adults aged 18-70 with Irritable Bowel Syndrome (IBS) and mild psychological symptoms, but no psychiatric diagnosis. Participants must not have taken certain probiotics recently, be free from serious systemic diseases or gastrointestinal pathologies other than IBS, and not have had major abdominal surgery or used antibiotics in the last month.

Inclusion Criteria

Willing and able to sign written informed consent prior to study entry

I have mild to moderate depression or anxiety but no psychiatric diagnosis.

I have been diagnosed with IBS and my symptoms are currently active.

Exclusion Criteria

Pregnant or breastfeeding women

Subjects currently participating or having participated in a therapeutic trial within 3 months prior to the date of randomization

History of substance abuse in the past 2 years, including opiates, phencyclidine, benzodiazepines, amphetamines, cocaine, heroin, alcohol, and cannabinoids (except if medically indicated)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Bifidobacterium Longum NCC3001 or placebo for 6 weeks

6 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bifidobacterium longum NCC3001

Trial Overview The trial is testing Bifidobacterium longum NCC3001's effects on intestinal and psychological symptoms in IBS patients. It's a controlled study where participants are randomly assigned to receive either the test probiotic or a placebo without knowing which one they're getting.

How Is the Trial Designed?

Group I: Probiotic Active Control 1 Intervention

Bifidobacterium longum \[BL NCC3001\]

Group II: Placebo Placebo Group 1 Intervention

Maltodextrin

Bifidobacterium longum NCC3001 is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Bifidobacterium longum NCC3001 for:

• Irritable Bowel Syndrome

Approved in Canada as Bifidobacterium longum NCC3001 for:

• Irritable Bowel Syndrome

Approved in European Union as Bifidobacterium longum NCC3001 for:

• Irritable Bowel Syndrome

Who Is Running the Clinical Trial?

Société des Produits Nestlé (SPN)

Lead Sponsor

Trials

349

Recruited

63,400+

Nestlé

Lead Sponsor

Trials

322

Recruited

60,500+

Laurent Freixe

Nestlé

Chief Executive Officer

MBA from ESSEC Business School

Brian Groves

Nestlé

Chief Marketing Officer since 2023

Bachelor's degree in Marketing

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

CERBA

Collaborator

Trials

2

Recruited

980+

Medidata Solutions

Industry Sponsor

Trials

25

Recruited

25,600+

CaligorRx, Inc.

Collaborator

Trials

2

Recruited

150+

CERBA Research

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

In a pilot study involving 16 patients with diarrhea-predominant irritable bowel syndrome (IBS-D), treatment with the probiotic Bifidobacterium longum ES1 for 12 weeks led to significant reductions in pro-inflammatory cytokines and improved gastrointestinal symptoms, particularly abdominal pain and stool consistency.

The study found that 50% of patients treated for 12 weeks reported a clinical response, while only 13% of those treated for 8 weeks did, suggesting that longer treatment duration may enhance efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Response and Changes of Cytokines and Zonulin Levels in Patients with Diarrhoea-Predominant Irritable Bowel Syndrome Treated with Bifidobacterium Longum ES1 for 8 or 12 Weeks: A Preliminary Report. Caviglia, GP., Tucci, A., Pellicano, R., et al.[2020]

In an 8-week study involving 37 adults with irritable bowel syndrome (IBS), the probiotic Bifidobacterium longum 35624® led to a significant 43.4% reduction in total IBS symptom scores, indicating effective symptom relief.

Over 60% of participants experienced clinically meaningful improvements in their IBS symptoms, with most reporting their treatment as 'good to satisfactory', and only one mild adverse event (nausea) was noted, suggesting the probiotic is well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An 8-Week Course of Bifidobacterium longum 35624® Is Associated with a Reduction in the Symptoms of Irritable Bowel Syndrome. Lenoir, M., Wienke, J., Fardao-Beyler, F., et al.[2023]

Bifidobacterium longum W11 has been shown to significantly reduce symptoms in patients with irritable bowel syndrome (IBS) with constipation, based on a review of 7 clinical trials and various in vitro studies.

This probiotic strain is unique for its non-transmissible antibiotic resistance, allowing it to be safely co-administered with rifaximin, leading to improved clinical outcomes in patients with diverticular disease compared to rifaximin alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bifidobacterium longum W11: Uniqueness and individual or combined clinical use in association with rifaximin. Di Pierro, F., Pane, M.[2021]

In a study involving 636 patients with constipation-variant IBS, a symbiotic treatment combining the probiotic Bifidobacterium longum W11 and the prebiotic Fos Actilight significantly increased stool frequency from an average of 2.9 to 4.1 times per week.

The treatment also led to a notable reduction in abdominal pain and bloating, with severe symptoms decreasing from 62.9% to 9.6% for bloating and from 38.8% to 4.1% for abdominal pain, indicating both efficacy and safety in managing IBS symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a symbiotic preparation on the clinical manifestations of irritable bowel syndrome, constipation-variant. Results of an open, uncontrolled multicenter study. Colecchia, A., Vestito, A., La Rocca, A., et al.[2015]

A review of seven selected studies, including three clinical trials, suggests that Bifidobacterium supplementation may improve symptoms in some patients with irritable bowel syndrome (IBS), but the evidence is not strong or consistent.

The meta-analysis indicated that Bifidobacterium alone does not show clear efficacy compared to other probiotics, highlighting the need for further research to establish its role in IBS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supplementation With Bifidobacterium and Symptomatic Control in Irritable Bowel Syndrome: An Evidence-Based Review. Terra, I., Santeiro, C., da Fonseca Rua, J.[2023]

Bifidobacterium infantis 35624 (B. infantis 35624) is a probiotic that has been shown to effectively reduce both individual and overall symptoms of irritable bowel syndrome (IBS) in two randomized controlled trials.

This probiotic appears to be safe for use, as there were no reported increases in adverse events, making it a promising alternative treatment for IBS, especially given the lack of effective medications due to side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bifidobacterium infantis 35624: a novel probiotic for the treatment of irritable bowel syndrome. Brenner, DM., Chey, WD.[2022]

In a study of 44 adults with irritable bowel syndrome (IBS), the probiotic Bifidobacterium longum NCC3001 (BL) significantly reduced depression scores after 6 weeks compared to a placebo, with 14 out of 22 patients in the BL group showing improvement.

The use of BL also led to an increase in quality of life and altered brain activation patterns in response to negative emotional stimuli, suggesting a potential mechanism for its effects on depression in IBS patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic Bifidobacterium longum NCC3001 Reduces Depression Scores and Alters Brain Activity: A Pilot Study in Patients With Irritable Bowel Syndrome. Pinto-Sanchez, MI., Hall, GB., Ghajar, K., et al.[2022]

In a real-life study involving 233 patients with irritable bowel syndrome (IBS), treatment with Bifidobacterium longum 35624 for 30 days significantly reduced IBS severity, with 57% of patients moving to lower severity categories or achieving remission.

The quality of life for patients improved as well, with a notable increase in scores on the IBS Quality of Life questionnaire, and 63.8% of patients reported satisfaction with the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome. Sabaté, JM., Iglicki, F.[2022]

The probiotic strains Bifidobacterium longum KABP042 and Pediococcus pentosaceus KABP041 were found to be safe and effective in reducing the severity of functional gastrointestinal disorders (FGIDs) in infants, as shown in a pilot study with 36 infants over 14 days.

These strains demonstrated strong antimicrobial properties against various pathogens and improved gut health by enhancing the expression of tight junction proteins, indicating their potential as a therapeutic option for pediatric FGIDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotic Properties of Bifidobacterium longum KABP042 and Pediococcus pentosaceus KABP041 Show Potential to Counteract Functional Gastrointestinal Disorders in an Observational Pilot Trial in Infants. Astó, E., Huedo, P., Altadill, T., et al.[2023]

In a double-blind, placebo-controlled trial involving 443 patients with irritable bowel syndrome (IBS), non-viable Bifidobacterium bifidum MIMBb75 significantly improved symptoms, with 34% of patients experiencing relief compared to 19% in the placebo group (p=0.0007).

The non-viable probiotic was well-tolerated, with no serious adverse events reported, and 91% of patients rated its tolerability as very good or good, suggesting it is a safe option for IBS treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heat-inactivated Bifidobacterium bifidum MIMBb75 (SYN-HI-001) in the treatment of irritable bowel syndrome: a multicentre, randomised, double-blind, placebo-controlled clinical trial. Andresen, V., Gschossmann, J., Layer, P.[2020]

In a non-interventional study involving 221 patients with IBS over 12 weeks, the probiotic Lactobacillus plantarum 299v (LP299V) significantly reduced overall IBS symptoms, including abdominal pain and flatulence, with a notable improvement in quality of life.

94% of patients reported good tolerability of LP299V, suggesting that long-term use of this probiotic is safe and effective for managing IBS symptoms in everyday conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of IBS with Lactobacillus plantarum 299v: Therapeutic success increases with length of treatment - real-life data of a non-interventional study in Germany]. Krammer, H., Storr, M., Madisch, A., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11832793/

An 8-Week Course of Bifidobacterium longum 35624® Is ... We conclude that an 8-week course of B. longum 35624 was associated with significant, clinically meaningful symptom relief in a typical population of adult ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8891724/

Effect of Bifidobacterium longum 35624 on disease severity ... After a 30-d treatment period with one B. longum 35624 capsule per day, a significant decrease in IBS severity was observed compared to baseline (mean ± SD, IBS ...

3. microbiotajournal.com microbiotajournal.com/wp-content/uploads/sites/7/2024/06/e998.pdf

EFFECTIVENESS OF BIFIDOBACTERIUM LONGUM ... Abstract – Objective: The main purpose of this review is to systematize the data on the effectiveness of Bi- fidobacterium longum 35624 in the treatment of ...

4. gastrojournal.org gastrojournal.org/article/s0016-5085(17)35557-9/fulltext

Probiotic Bifidobacterium longum NCC3001 Reduces ... In a placebo-controlled trial, we found that the probiotic BL reduces depression but not anxiety scores and increases quality of life in patients with IBS.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04922476?tab=table

Effect of 35624® Alflorex® in Functional Gastrointestinal ... The aim of this study is to evaluate the effect of supplementation with Bifidobacterium longum 35624® Alflorex® on frequency and severity of symptoms of ...

6. gastrojournal.org gastrojournal.org/article/S0016-5085(23)04838-2/fulltext

Efficacy of Probiotics in Irritable Bowel Syndrome Some probiotics may be beneficial in irritable bowel syndrome (IBS), but differences in species and strains used, as well as endpoints reported, have hampered ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/19490976.2024.2338322

A randomized double-blind, placebo-controlled trial to ... A randomized double-blind, placebo-controlled trial to evaluate the safety and efficacy of live Bifidobacterium longum CECT 7347 (ES1) and heat- ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1743919120301539

The efficacy and safety of probiotics in patients with irritable ... We performed a systematic review and meta-analysis of 46 RCTs to evaluate the efficacy and safety of probiotics in patients with IBS.