B. Lactis HN019 for Functional Constipation

Study Overview
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Brief Summary
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This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.

Detailed Description
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This prospective, double-blind, randomized, placebo-controlled clinical trial will investigate the effects of 4-week B. lactis HN019 supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation. Participants who meet all study entry criteria will enter a 2-week run-in period. Following successful completion of the run-in period, subjects will be randomized to 4-week supplementation with B. lactis HN019 (10 billion cfu), B. lactis HN019 (1 billion cfu), or placebo. The primary outcome of whole gut transit time will be evaluated with abdominal x-rays on days 0 and 28. Secondary outcomes include IBS-specific questionnaires (administered on days 0 and 28); abdominal pain severity, bowel movement frequency, stool consistency, and adverse events (evaluated daily throughout the study); and overall product satisfaction (evaluated at day 28). Physical activity questionnaires and 24-hour food recalls will be completed periodically during the trial.

Official Title
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Effects of 4-week Bifidobacterium Lactis HN019 Supplementation on Whole Gut Transit Time and Gastrointestinal Symptoms in Adults With Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial

Conditions
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Constipation

Intervention / Treatment
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* Dietary Supplement: B. lactis HN019
* Dietary Supplement: B. lactis HN019
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 70 years Body mass index between 18.5 and 34.9 kg/m2 Self-reported unsatisfactory defecation due to infrequent stools and/or difficult stool passage, which includes at least one of the following: symptoms of straining, difficulty expelling stool, a sense of incomplete evacuation, hard or lumpy stools, prolonged time to stool, or a need for manual maneuvers to pass stool. Estimated stool consistency < 4.0 on BSSF (self-reported at screening) within the past month prior to enrollment. Ability of the participant (in the investigator's opinion) to comprehend the full nature and purpose of the study including possible risks and side effects Consent to the study and willing to comply with study product and methods Exclusion Criteria: Major gastrointestinal complication (e.g. Crohn's disease, ulcer) Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the subject or confound study results Clinically significant underlying systemic illness that may preclude the subject's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness) Daily consumption of probiotics, prebiotics, fermented milk, and/or yogurt within 2 weeks of screening and throughout the trial other than the provided study products Non-laxative constipation medication use within 2 weeks of screening, laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study) Daily use of anticholinergic agents, opioid analgesics, calcium supplements, calcium-channel blockers, and NSAIDs Anticipated major dietary or exercise changes during the study Systemic steroid use Eating disorder Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product) History of alcohol, drug, or medication abuse Pregnant or lactating female, or pregnancy planned during study period Participation in another study with any investigational product within 30 days of screening Investigator believes that the participant may be uncooperative and/or noncompliant and should therefore not participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-dose probiotic<br>Capsule containing 10 billion cfu B. lactis HN019 | Dietary Supplement: B. lactis HN019<br>* Capsule containing 10 billion cfu B. lactis HN019 once a day<br>|
| Experimental: Low dose probiotic<br>Capsule containing 1 billion cfu B. lactis HN019 | Dietary Supplement: B. lactis HN019<br>* Capsule containing 1 billion cfu B. lactis HN019 once a day<br>|
| Placebo Comparator: Placebo<br>Placebo capsule | Dietary Supplement: Placebo<br>* Capsule containing no probiotic once a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole Gut Transit Time | The primary endpoint of this clinical trial is whole gut transit time, which will be assessed using abdominal x-rays on days 0 and 28 | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Constipation Symptoms (PAC-SYM) | The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28. | 4 weeks | 
| Patient Assessment of Constipation QoL (PAC-QoL) | The PAC-QoL is a 28-question survey that asks questions on their quality of life. | 4 weeks | 
| Bowel Function Index | The Bowel Function Index is a 3-question tool that asks subjects if they have experienced adequate relief of constipation symptoms over the past week. The Bowel Function Index will be completed at days 0 and 28. | 4 weeks | 
| Adequate Relief of Constipation (Yes/no) | Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28. | 4 weeks | 
| Bowel Movement Frequency | Subjects will record the number of defecations per day in a diary. | 4 weeks | 
| Stool Consistency | Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form | 4 weeks | 
| Overall Product Satisfaction | At the end of the supplementation period, subjects will be asked to rate their overall satisfaction with the study product's ability to relieve their constipation symptoms on a 5-point ordinal scale | 4 weeks | 
| Adverse Event Frequency | All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS-C, constipation, probiotic, functional constipation