ConstipationPhase 3CTTNCT01463293
B. Lactis HN019 for Functional Constipation
A Phase 3 study testing B. lactis HN019 in people with Constipation, run by Fonterra Research Centre at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation
- What is being tested?
- B. lactis HN019
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 12 sitesUnited States
- Study dates
- Mar 2012to May 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Research Across America
Carrollton, Texas, 75010
Research Across America
Dallas, Texas, 77054
Diagnamics, Inc.
Encinitas, California, 92024
Digestive & Liver Disease Specialists
Garden Grove, California, 92840
Arrowhead Family Health Center
Glendale, Arizona, 85306
Discovery Clinical Trials South Main
Houston, Texas, 77025
Research Across America
Katy, Texas, 77450
StayWell Research
Northridge, California, 91325
Village Health Partners
Plano, Texas, 75024
North Texas Family Medicine
Plano, Texas, 75093
Sprim ALS
San Francisco, California, 94109
Westlake Medical Research
Westlake Village, California, 91361
About this study
Official title: 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
This study will investigate the effects of 4-week probiotic supplementation on whole gut transit time and gastrointestinal symptoms in adults with functional constipation.
Read the 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.
- Conditions
- Constipation
- Being tested
- B. lactis HN019, Placebo
- Keywords
- constipation, probiotic, functional constipation, IBS-C
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B. lactis HN019Dietary supplement
Capsule containing 10 billion cfu B. lactis HN019 once a day
B. lactis HN019Dietary supplement
Capsule containing 1 billion cfu B. lactis HN019 once a day
PlaceboDietary supplement
Capsule containing no probiotic once a day
| Study group | Role | What they receive |
|---|---|---|
| High-dose probiotic | Experimental | Capsule containing 10 billion cfu B. lactis HN019 Receives: Dietary Supplement: B. lactis HN019 |
| Low dose probiotic | Experimental | Capsule containing 1 billion cfu B. lactis HN019 Receives: Dietary Supplement: B. lactis HN019 |
| Placebo | Placebo comparator | Placebo capsule Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 weeks
Bowel Movement Frequency
Subjects will record the number of defecations per day in a diary.
Measured: 4 weeks
Stool Consistency
Stool consistency will be rated each day in a diary by using the Bristol Stool Scale Form
Measured: 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
Measured: 4 weeks
Adverse Event Frequency
All adverse events, regardless of relationship with investigational product, will be reported during the 4-week follow-up period.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fonterra Research Centre
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DuPont Nutrition and Health
- Responsible party
- Sponsor
- Investigators
- Robert Hardi, MD, Principal investigator, Capital Digestive Care, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463293
- Sponsor's protocol ID
- 11-SUS-02-FON-02
- Acronym
- CTT
- Status last verified
- Jun 2014
- First submitted
- 28 Oct 2011
- Last updated
- 24 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01463293
- Acronym / sponsor ID
- CTT / 11-SUS-02-FON-02
- Conditions
- Constipation
- Keywords
- constipation, probiotic, functional constipation, IBS-C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Fonterra Research CentreIndustry (pharma, biotech, devices)
- Collaborators
- DuPont Nutrition and Health
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 1 Nov 2011 (estimated)
- Results
- Posted 24 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose probiotic | Experimental | Dietary Supplement: B. lactis HN019Capsule containing 10 billion cfu B. lactis HN019 |
| Low dose probiotic | Experimental | Dietary Supplement: B. lactis HN019Capsule containing 1 billion cfu B. lactis HN019 |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B. lactis HN019Capsule containing 10 billion cfu B. lactis HN019 once a day | Dietary supplement | High-dose probiotic |
| B. lactis HN019Capsule containing 1 billion cfu B. lactis HN019 once a day | Dietary supplement | Low dose probiotic |
| PlaceboCapsule containing no probiotic once a day | Dietary supplement | Placebo |
Primary outcome
Whole Gut Transit Time
Time frame: 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
8 secondary outcomes
Patient Assessment of Constipation Symptoms (PAC-SYM)
Time frame: 4 weeks
Patient Assessment of Constipation QoL (PAC-QoL)
Time frame: 4 weeks
Bowel Function Index
Time frame: 4 weeks
Adequate Relief of Constipation (Yes/no)
Time frame: 4 weeks
Bowel Movement Frequency
Time frame: 4 weeks
Stool Consistency
Time frame: 4 weeks
Overall Product Satisfaction
Time frame: 4 weeks
Adverse Event Frequency
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hardi, MD principal investigator
Capital Digestive Care, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing B. lactis HN019 in people with Constipation, run by Fonterra Research Centre at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whole Gut Transit Time (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.