A Trial to Evaluate the Effects of Bifidobacterium Longum... | NCT05054309

Status Module

Name	Class
Syneos Health	OTHER
Medidata Solutions	INDUSTRY
McMaster University	OTHER
CaligorRx, Inc.

Label	Type	Description	Intervention Names
Probiotic	Active Comparator	Bifidobacterium longum [BL NCC3001]	Dietary Supplement: Bifidobacterium longum
Placebo	Placebo Comparator	Maltodextrin	Dietary Supplement: Bifidobacterium longum

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Hospital Anxiety Depression Scale - Depression (HADS-D) score	Change from baseline to Week 6 in Hospital Anxiety Depression Scale-Depression (HADS-D) score, a 14-item scale assessing depression (7 items) of psychological distress. Each item is scored from 0-3 in a Likert manner. Outcome measures are the depression score (0-21).	Day -1, Day 43 (± 2 days)

Other Outcomes

Measure	Description	Time Frame
Microbiota composition - A subset of 80 subjects (40 per arm)	Changes in microbiota composition in feces	Day -1, Day 43 (± 2 days), Day 71 (± 2 days)
Microbiota metabolic activity in feces - A subset of 80 subjects (40 per arm)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Consumption of any probiotic supplements specified as containing Lactobacillus, Bifidobacteria, Streptococcus, Bacillus coagulans, and Saccharomyces at least 2 weeks prior to the date of randomization.
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).
Recently initiated exclusion diets. Subjects on stable exclusion diets (> 3 months prior to the date of randomization) will not be excluded. This includes subjects with the following diets: gluten-free, lactose-free, paleo, vegetarian, vegan, and low-carbohydrate.
Low-FODMAP diet. Subjects on the induction phase of the FODMAP exclusion will not be enrolled. Subjects on the maintenance phase of the diet for more than 3 months prior to the date of randomization with stable diet can be considered for enrollment.

Facility	Status	City	State	ZIP	Country	Contacts
University of Calgary		Calgary	Alberta	T2N 4Z6	Canada
University Of Alberta

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases