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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

Find a Location

Who is running the clinical trial?

Société des Produits Nestlé (SPN)Lead Sponsor
337 Previous Clinical Trials
62,377 Total Patients Enrolled
1 Trials studying Irritable Bowel Syndrome
40 Patients Enrolled for Irritable Bowel Syndrome
NestléLead Sponsor
321 Previous Clinical Trials
60,524 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment size for this clinical trial?

"Yes, according to the information on clinicaltrials.gov, this trial is currently enrolling participants. It was first advertised on February 11th 2022 and has since been modified as recently as October 24th 2022 with an increased recruitment goal of 184 people across 6 sites."

Answered by AI

Can I be a part of the experiment?

"To be considered for this medical trial, applicants need to have the disorder in question and must fall between 18-70 years of age. The total number of participants being accepted is 184."

Answered by AI

Are there numerous medical centers conducting this trial in North America?

"6 medical centres have opened their doors to enrollees, including McMaster University in Hamilton, PerCuro Clinical Research Ltd. based in Victoria and Canadian Phase Onward Inc. stationed in Toronto - with additional facilities located across the country."

Answered by AI

What core outcomes is this trial seeking to achieve?

"This clinical trial aims to evaluate the efficacy of Bifidobacterium Longum (BL NCC3001) on Gastrointestinal Symptoms. Patient progress will be monitored over a 6-week period, while secondary objectives include quantifying changes in IBS-SSS Bloating severity, IBS-SSS Life impact and HADS-Anxiety (HADS-A)."

Answered by AI

Does the protocol for this trial limit participants to those under forty years of age?

"This clinical trial requires applicants to be between 18 and 70 years old. A further 381 trials are available for those under the age of majority, while 1014 studies accept patients over 65."

Answered by AI

Is this experiment currently open to new enrollees?

"Reportedly, this clinical trial is ongoing. It was initially published on February 11th 2022 and the most recent update occurred October 24th of the same year."

Answered by AI

Who else is applying?

What state do they live in?
Washington
What site did they apply to?
PerCuro Clinical Research Ltd.
University of Calgary
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. PerCuro Clinical Research Ltd.: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome
2022. "A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05054309.
All > Irritable Bowel Syndrome > Psychological
~39 spots leftby Nov 2024
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