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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day -1, day 43 (± 2 days), day 71 (± 2 days)
Awards & highlights

Mood-01 Trial Summary

This trial will study the effect of a new drug on Irritable Bowel Syndrome. It is placebo controlled, meaning some patients will receive the drug and some will receive a fake drug, and double blind, meaning neither the patients nor the doctors will know who is receiving which.

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.Check my eligibility
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.See study design
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.

Mood-01 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with IBS and my symptoms are currently active.
Select...
I am between 18 and 70 years old.

Mood-01 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
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

Mood-01 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ProbioticActive Control1 Intervention
Bifidobacterium longum [BL NCC3001]
Group II: PlaceboPlacebo Group1 Intervention
Maltodextrin

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.

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Who is running the clinical trial?

Société des Produits Nestlé (SPN)Lead Sponsor
337 Previous Clinical Trials
62,375 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
40 Patients Enrolled for Irritable Bowel Syndrome
NestléLead Sponsor
321 Previous Clinical Trials
60,518 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
40 Patients Enrolled for Irritable Bowel Syndrome
Premsyl Bercik, MDPrincipal InvestigatorMcMaster University

Media Library

Bifidobacterium longum NCC3001 (Probiotic) Clinical Trial Eligibility Overview. Trial Name: NCT05054309 — N/A
Irritable Bowel Syndrome Research Study Groups: Probiotic, Placebo
Irritable Bowel Syndrome Clinical Trial 2023: Bifidobacterium longum NCC3001 Highlights & Side Effects. Trial Name: NCT05054309 — N/A
Bifidobacterium longum NCC3001 (Probiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05054309 — N/A
~28 spots leftby Nov 2024
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