What side effects are associated with this type of intervention?

Common treatments for Irritable Bowel Syndrome (IBS) include probiotics, dietary changes, fiber supplements, and psychosocial therapies. Probiotics, such as Bifidobacterium Longum NCC3001, are generally well-tolerated but can cause mild side effects like bloating, gas, and digestive discomfort. Fiber supplements may also lead to increased gas and bloating, especially when first introduced. Psychosocial therapies, including cognitive behavioral therapy and hypnosis, typically have minimal physical side effects but may require a time commitment and emotional investment. It is important to discuss these options with a healthcare provider to tailor the treatment to individual needs and minimize potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Irritable Bowel Syndrome (IBS), including medications like linaclotide and rifaximin, which target different symptoms of IBS. Linaclotide is used for IBS with constipation (IBS-C) and works by increasing fluid secretion in the intestines to ease stool passage. Rifaximin is an antibiotic approved for IBS with diarrhea (IBS-D) and works by altering gut bacteria. While specific probiotics like BL NCC3001 are still under investigation, the concept of using probiotics to modulate gut microbiota and reduce IBS symptoms is supported by studies showing the potential benefits of various probiotic strains in managing IBS symptoms.

What other types of research exist?

Promising alternatives to BL NCC3001 for IBS treatment include: 1) Lactobacillus reuteri DSM 17938, which has shown efficacy in reducing gastrointestinal symptoms; 2) Synbiotics combining probiotics like Bifidobacterium breve with prebiotics such as galacto-oligosaccharides (GOS) and fructo-oligosaccharides (FOS), which have demonstrated benefits in gut health; 3) Guanylate cyclase agonists like linaclotide and plecanatide, which enhance intestinal fluid secretion and transit, providing relief from constipation-predominant IBS.

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Probiotic

Probiotic for Irritable Bowel Syndrome (Mood-01 Trial)

N/A

Recruiting

Led By Premsyl Bercik, MD

Research Sponsored by Société des Produits Nestlé (SPN)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Male or female, age between 18 and 70 years inclusive

Must not have

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)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day -1, day 43 (± 2 days), day 71 (± 2 days)

Summary

This trial is testing BL NCC3001 to see if it helps people with Irritable Bowel Syndrome (IBS). IBS can cause discomfort and has limited treatment options. The study aims to find out if this new treatment can reduce IBS symptoms.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed for this probiotic, common ones may include digestive discomfort such as gas or bloating. Allergic reactions could occur but are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication regularly for IBS.

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I have been diagnosed with a mood or anxiety disorder by a psychiatrist.

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I have been diagnosed with celiac disease by a doctor.

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I do not have serious stomach or intestine diseases except for common, non-dangerous conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day -1, day 43 (± 2 days), day 71 (± 2 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day -1, day 43 (± 2 days), day 71 (± 2 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day -1, day 43 (± 2 days), day 71 (± 2 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms

To evaluate the effect of Bifidobacterium Longum (BL NCC3001) on Psychological Symptoms

Secondary study objectives

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

Amount of Bifidobacterium Longum (BL NCC3001) present in stool

Depression Anxiety Stress Scale (DASS-21)

+15 more

Other study objectives

Amount of Bifidobacterium Longum (BL NCC3001) in stool

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

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

+5 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ProbioticActive Control1 Intervention

Bifidobacterium longum \[BL NCC3001\]

Group II: PlaceboPlacebo Group1 Intervention

Maltodextrin

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Irritable Bowel Syndrome (IBS) include dietary modifications, probiotics, and medications. Dietary changes, such as a low FODMAP diet, reduce the intake of fermentable carbohydrates that can cause bloating and discomfort. Probiotics, like Bifidobacterium longum NCC3001, aim to restore a healthy balance of gut microbiota, which can alleviate symptoms like abdominal pain and bloating by reducing inflammation and improving gut barrier function. Medications may target specific symptoms, such as antispasmodics for pain or laxatives for constipation. Understanding these mechanisms is crucial for IBS patients as it helps tailor treatments to their specific symptoms and underlying causes, potentially improving their quality of life.