B. Lactis HN019 for Functional Constipation

Phase 3

Completed

Interventions: Dietary Supplement: B. lactis HN019
Dietary Supplement: Placebo

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Low dose probiotic	B. lactis HN019	Capsule containing 1 billion cfu B. lactis HN019
Placebo	Placebo	Placebo capsule
High-dose probiotic	B. lactis HN019	Capsule containing 10 billion cfu B. lactis HN019

Primary Outcome Measures

Name	Time	Method
Whole Gut Transit Time	4 weeks	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

Secondary Outcome Measures

Name	Time	Method
Patient Assessment of Constipation QoL (PAC-QoL)	4 weeks	The PAC-QoL is a 28-question survey that asks questions on their quality of life.
Bowel Movement Frequency	4 weeks	Subjects will record the number of defecations per day in a diary.
Stool Consistency	4 weeks	Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form
Patient Assessment of Constipation Symptoms (PAC-SYM)	4 weeks	The PAC-SYM tool asks 12 questions on the symptoms of constipation. Subjects will complete the PAC-SYM at days 0 and 28.
Adequate Relief of Constipation (Yes/no)	4 weeks	Adequate relief of constipation (yes/no) This (yes/no) questionnaire will be completed at days 0 and 28.
Bowel Function Index	4 weeks	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.
Overall Product Satisfaction	4 weeks	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
Adverse Event Frequency	4 weeks	All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.

Locations (10): Diagnamics, Inc.
🇺🇸
Encinitas, California, United States
Westlake Medical Research
🇺🇸
Westlake Village, California, United States
Digestive & Liver Disease Specialists
🇺🇸
Garden Grove, California, United States
StayWell Research
🇺🇸
Northridge, California, United States
Discovery Clinical Trials South Main
🇺🇸
Houston, Texas, United States
Sprim ALS
🇺🇸
San Francisco, California, United States
Research Across America
🇺🇸
Katy, Texas, United States
Village Health Partners
🇺🇸
Plano, Texas, United States
North Texas Family Medicine
🇺🇸
Plano, Texas, United States
Arrowhead Family Health Center
🇺🇸
Glendale, Arizona, United States