A Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome

NCT05054309 | Completed

• 1 other identifier: 20.01.CLI
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 11

Brief Summary

This is a prospective, randomized, placebo-controlled, double-blind, multi-center parallel- design study to evaluate the effect of BL NCC3001 in subjects with Irritable Bowel Syndrome.

Conditions

IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

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

  Change from baseline to week 6 in Irritable Bowel Severity Scoring System (IBS-SSS), a questionnaire that includes 5 questions related to the severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life over the past 10 days. This cumulative score can therefore range from 0 to 500, with higher scores indicating more severe symptoms.

  Baseline to 6 weeks.

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

  Change from baseline to week 6 in Hospital Anxiety and Depression Scale (HADS-Total) score, a 14-item scale assessing two dimensions (anxiety and depression, 7 items for each) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the anxiety score (0-21), depression score (0-21) and the total score (0-42).

  Baseline to 6 weeks.

Secondary Outcomes (18)

• Hospital Anxiety Depression Scale - Depression (HADS-D) score

  Day -1, Day 43 (± 2 days)

• Hospital Anxiety Depression Scale - Anxiety (HADS-A) score

  Day -1, Day 43 (± 2 days)

• Depression Anxiety Stress Scale (DASS-21)

  Day -1, Day 43 (± 2 days)

• Perceived Stress Scale (PSS)

  Day -1, Day 43 (± 2 days)

• Irritable Bowel Severity Scoring System (IBS-SSS) Pain severity

  Day -1, Day 43 (± 2 days)

Other Outcomes (8)

• Microbiota composition - A subset of 80 subjects (40 per arm)

  Day -1, Day 43 (± 2 days), Day 71 (± 2 days)

• Microbiota metabolic activity in feces - A subset of 80 subjects (40 per arm)

  Day -1, Day 43 (± 2 days)

• Microbiota metabolic activity in blood - A subset of 80 subjects (40 per arm)

  Day -1, Day 43 (± 2 days)

Study Arms (2)

Probiotic

ACTIVE COMPARATOR

Bifidobacterium longum \[BL NCC3001\]

Dietary Supplement: Bifidobacterium longum

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Bifidobacterium longum

Interventions

Bifidobacterium longum DIETARY_SUPPLEMENT

A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effects of Bifidobacterium Longum NCC3001 on Intestinal and Psychological Symptoms in Subjects With Irritable Bowel Syndrome

Placebo; Probiotic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age between 18 and 70 years inclusive.
• Willing and able to sign written informed consent prior to study entry.
• Able to comply with the study procedures, in the opinion of the investigator.
• 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.
• Subjects with psychological symptoms in the absence of a psychiatric diagnosis, defined as a score of 5 to 13 in the depression domain and/or a score of 4 to 9 in the anxiety domain of the DASS-21 questionnaire.

You may not qualify if:

• 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.
• Concurrent systemic disease and/ or laboratory abnormalities considered by the investigator to be clinically relevant or that could interfere with data collection or interpretation.
• Concurrent organic gastrointestinal pathology other than benign polyps, diverticulosis, hemorrhoids, lipomas, and melanosis coli.
• History of attempted suicide in the past 5 years.
• Previous abdominal surgery except for hernia repair, appendectomy, caesarian section, tubal ligation, hysterectomy, and hemorrhoidectomy.
• History of substance abuse in the past 2 years, including opiates, phencyclidine, benzodiazepines, amphetamines, cocaine, heroin, alcohol, and cannabinoids (except if medically indicated).
• Subjects who are on daily treatment with therapeutic doses of drugs having central nervous system effects, including antidepressants and/ or anxiolytics. Low doses of (I) tricyclic antidepressants for abdominal pain/diarrhea related to IBS and (II) anxiolytics used as sleeping pills will be permitted if dose is stable \> 3 months prior to the date of randomization.
• Pregnant or breastfeeding women.
• Subjects with dementia or other cognitive impairment.
• Subjects who received antibiotics within the 4 weeks prior to the date of randomization .
• Known or suspected allergies to the study products.
• Subjects with increased risk of probiotic sepsis as the following conditions: Immune compromise, including debilitating state or malignancy, central venous catheter, impaired intestinal epithelial barrier (acute diarrheal illness, intestinal inflammation, etc.), cardiac valvular disease.
• Subjects currently participating or having participated in a therapeutic trial within 3 months prior to the date of randomization.
• Medically diagnosed lactose intolerance and fructose intolerance without being on a stable lactose or fructose free diet (\> 3 months prior to the date of randomization).
• Medically diagnosed celiac disease.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead
• Syneos Health: collaborator
• Medidata Solutions: collaborator
• McMaster University: collaborator
• CaligorRx, Inc.: collaborator

Study Sites (11)

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University Of Alberta

Edmonton, Alberta, T6G 2P8, Canada

Location

Eastern Regional Health Authority

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Medicor Research Inc.

Greater Sudbury, Ontario, P3C 1X3, Canada

Location

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Scott Shulman Medicine Professional Corporation

North Bay, Ontario, P1B 2H3, Canada

Location

The Ottawa Hospital General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3J 0K2, Canada

Location

Diex Recherche Quebec Inc.

Québec, Quebec, G1V 4T3, Canada

Location

DIEX Recherche

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

Location

PerCuro Clinical Research Ltd.

Victoria, V8V 3M9, Canada

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Premsyl Bercik, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: February 11, 2022
• Primary Completion: December 4, 2024
• Study Completion: February 14, 2025
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (11)