ConstipationPhase 2NCT02189707
Effects of Probiotic Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Constipation.
A Phase 2 study testing Probiotic Bifidobacterium 1x1010 cfu and Probiotic Bifidobacterium 1x109 cfu in people with Constipation and Gastrointestinal Disorder, run by Danisco Sweeteners Oy at 1 site in France.
Trial summary
To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Gastrointestinal Disorder
- What is being tested?
- Probiotic Bifidobacterium 1x1010 cfu and Probiotic Bifidobacterium 1x109 cfu
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2014to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age 18 to 70 years
- 2.Body mass index between 18.5 and 34.9 kg/m2
- 3. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
- Must meet 2 or more of the following criteria:
- Straining during at least 25% of defecations
- Lumpy or hard stools in at least 25% of defecations
Show all 11Show fewer
- Sensation of incomplete evacuation for at least 25% of defecations
- Sensation of anorectal obstruction/blockage for at least 25% of defecations+ Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
- Fewer than three defecations per week
- Loose stools are rarely present without the use of laxatives
- Insufficient criteria for irritable bowel syndrome
Who cannot join
- 1.Major gastrointestinal complication (e.g. Crohn's disease, ulcer)
- 2. Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or confound study results
- 3. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
- 4. 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
- 5. Laxative use within 48 hours of screening (rescue medication allowed for intolerable symptoms during study)
- 6. Regular use of any drug or dietary supplement known to cause constipation (e.g. iron, opioids, sucralfate, misoprostol, 5-Hydroxytryptamine#-antagonists, antacids with magnesium, calcium or aluminum, antidiarrheal medication, anticholinergic agents, calcium supplements, calcium channel blockers, tricyclic antidepressants or nonsteroidal antiinflammatory drugs), within 1 month before screening.
Show all 12Show fewer
- 7. Anticipated major dietary or exercise changes during the study
- 8. Systemic steroid use, within 1 month before screening.
- 9. Eating disorder
- 10. Contraindication to dairy products (e.g., intolerance to lactose or any substance in the study product)
- 11. History of alcohol, drug, or medication abuse
- 12. Pregnant or lactating female, or pregnancy planned during study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 4-week Bifidobacterium-lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial
To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.
Read the detailed description
Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12-19%, which results in lower quality of life and significant healthcare costs to the individual. Almost 9 in 10 physician visits for constipation result in a laxative prescription. Additionally, consumers in the USA and in the United Kingdom spend almost 1 billion dollars annually for over-the-counter laxatives. Chronic constipation is diagnosed almost solely on patient symptoms, which generally includes unsatisfactory defecation due to infrequent stools, difficult stool passage, or both. The cause of chronic constipation is unknown and likely multifactorial with physiological changes, psychological factors, and lifestyle influences identified as possible culprits. Consequently, identification of effective constipation treatments remains a challenge.
The initial management of constipation symptoms is focused on evaluating lifestyle and diet variables as possible culprits. If lifestyle modifications are unsuccessful in alleviating constipation, various medications may be prescribed. In fact, about 50% of adults with constipation are not completely satisfied with available treatments. Consequently, there is a clear need for alternative constipation treatments that are safe, effective, and cost-effective.
Probiotics are live micro-organisms that result in a health benefit for the host when administered in adequate dosages. In recent years, probiotics have been commonly used to alleviate symptoms in a variety of gastrointestinal disorders. It is hypothesized that probiotics help to maintain gut lumen homeostasis by hindering growth of luminal pathogens and restoring the normal flora of the gut. As such, the use of probiotics for the relief of constipation symptoms is very promising. Numerous studies have been published addressing the utility of probiotics for gastrointestinal health including constipation. However, since probiotic efficacy is largely strain-specific, each specific strain must be individually tested in clinical trials.
Given the promising clinical results of probiotics on gastrointestinal health to date, the objective of this clinical trial is to evaluate the safety and effectiveness of 4-week Bifidobacterium lactis HN019 supplementation, in a dose-ranging fashion, on Colonic Transit Time (CTT) and gastrointestinal symptoms in adults with constipation.
- Conditions
- Constipation, Gastrointestinal Disorder
- Being tested
- Probiotic Bifidobacterium 1x1010 cfu, Probiotic Bifidobacterium 1x109 cfu, Placebo powder in capsules
- Keywords
- Gastrointestinal disorder, Constipation, Probiotics, Dietary supplement
- Medical subject headings
- Constipation, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Bifidobacterium 1x1010 cfuDietary supplement
Also called Probiotic powder (1 x1010 cfu B. lactis HN019) in capsules
Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.
Probiotic Bifidobacterium 1x109 cfuDietary supplement
Also called Probiotic powder (1 x 109 cfu B. lactis HN019) in capsules
Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.
Placebo powder in capsulesOther
Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Bifidobacterium 1x1010 cfu | Experimental | One capsule of study product, mixed with provided yogurt, will be consumed once a day. Receives: Dietary Supplement: Probiotic Bifidobacterium 1x1010 cfu |
| Probiotic Bifidobacterium 1x109 cfu | Experimental | One capsule of study product, mixed with provided yogurt, will be consumed once a day. Receives: Dietary Supplement: Probiotic Bifidobacterium 1x109 cfu |
| Placebo powder in capsules | Placebo comparator | One capsule of study product, mixed with provided yogurt, will be consumed once a day. Receives: Other: Placebo powder in capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Colonic transit time
Measured: The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28
Secondary outcomes (10)
Patient (syn. participant) assessment of constipation symptoms (PAC-SYM)
Measured: At days 0 and 28
Patient Assessment of Constipation Quality of Life (PAC-QoL)
Measured: At days 0 and 28
Bowel Function Index
Measured: At days 0 and 28
Adequate Relief of constipation (yes/no)
Measured: At days 0 and 28
Bowel movement frequency stools per week)
Measured: Participants will record the number of defecations per day in a daily diary during the 2-week run-in period and each day during the 4-week supplementation period
Stool consistency (Bristol Stool Scale)
Measured: Participants will record stool consistency during the 2-week run-in period and each day during the 4-week supplementation period.
Degree of Straining (1-5 scale)
Measured: Participants will record degree of straining during the 2-week run-in period and each day during the 4-week supplementation period.
Participant assessment of bowel emptying (yes/no)
Measured: Participants will record sensation of complete bowel emptying during the 2-week run-in period and each day during the 4-week supplementation period.
Abdominal discomfort/bloating (1-5 scale)
Measured: Participants will record severity of abdominal discomfort and bloating during the 2-week run-in period and each day during the 4-week supplementation period.
Overall product satisfaction (1-5 scale)
Measured: At the end of the supplementation period (D28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danisco Sweeteners Oy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Responsible party
- Sponsor
- Investigators
- Mathilde Latreille-Barbier, MD, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02189707
- Sponsor's protocol ID
- Bifido transit 3
- Status last verified
- May 2015
- First submitted
- 4 Jul 2014
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 4-week Bifidobacterium-lactis HN019 Supplementation on Colonic Transit Time and Gastrointestinal Symptoms in Adults With Functional Constipation: A Double-blind, Randomized, Placebo-controlled Dose-ranging Trial
- ClinicalTrials.gov ID
- NCT02189707
- Acronym / sponsor ID
- Bifido transit 3
- Conditions
- Constipation, Gastrointestinal Disorder
- Keywords
- Gastrointestinal disorder, Constipation, Probiotics, Dietary supplement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Danisco Sweeteners OyIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Optimed
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 14 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if Bifidobacterium lactis HN109 improves transit time and gastrointestinal symptoms in adults with constipation.
Detailed description
Constipation is a commonly diagnosed gastrointestinal disorder with an estimated prevalence in the general population of 12-19%, which results in lower quality of life and significant healthcare costs to the individual. Almost 9 in 10 physician visits for constipation result in a laxative prescription. Additionally, consumers in the USA and in the United Kingdom spend almost 1 billion dollars annually for over-the-counter laxatives. Chronic constipation is diagnosed almost solely on patient symptoms, which generally includes unsatisfactory defecation due to infrequent stools, difficult stool passage, or both. The cause of chronic constipation is unknown and likely multifactorial with physiological changes, psychological factors, and lifestyle influences identified as possible culprits. Consequently, identification of effective constipation treatments remains a challenge.
The initial management of constipation symptoms is focused on evaluating lifestyle and diet variables as possible culprits. If lifestyle modifications are unsuccessful in alleviating constipation, various medications may be prescribed. In fact, about 50% of adults with constipation are not completely satisfied with available treatments. Consequently, there is a clear need for alternative constipation treatments that are safe, effective, and cost-effective.
Probiotics are live micro-organisms that result in a health benefit for the host when administered in adequate dosages. In recent years, probiotics have been commonly used to alleviate symptoms in a variety of gastrointestinal disorders. It is hypothesized that probiotics help to maintain gut lumen homeostasis by hindering growth of luminal pathogens and restoring the normal flora of the gut. As such, the use of probiotics for the relief of constipation symptoms is very promising. Numerous studies have been published addressing the utility of probiotics for gastrointestinal health including constipation. However, since probiotic efficacy is largely strain-specific, each specific strain must be individually tested in clinical trials.
Given the promising clinical results of probiotics on gastrointestinal health to date, the objective of this clinical trial is to evaluate the safety and effectiveness of 4-week Bifidobacterium lactis HN019 supplementation, in a dose-ranging fashion, on Colonic Transit Time (CTT) and gastrointestinal symptoms in adults with constipation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotic Bifidobacterium 1x1010 cfu | Experimental | Dietary Supplement: Probiotic Bifidobacterium 1x1010 cfuOne capsule of study product, mixed with provided yogurt, will be consumed once a day. |
| Probiotic Bifidobacterium 1x109 cfu | Experimental | Dietary Supplement: Probiotic Bifidobacterium 1x109 cfuOne capsule of study product, mixed with provided yogurt, will be consumed once a day. |
| Placebo powder in capsules | Placebo comparator | Other: Placebo powder in capsulesOne capsule of study product, mixed with provided yogurt, will be consumed once a day. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age 18 to 70 years
- 2.Body mass index between 18.5 and 34.9 kg/m2
- 3. Meets the Rome III criteria for functional constipation as follows: (Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis):
Key exclusion criteria (12 listed)
- 1.Major gastrointestinal complication (e.g. Crohn's disease, ulcer)
- 2. Prior abdominal surgery that, in the opinion of the investigator, may present a risk for the participant or confound study results
- 3. Clinically significant underlying systemic illness that may preclude the participant's ability to complete the trial or that may confound the study outcomes (e.g. bowel cancer, prostate cancer, terminal illness)
- 4. 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
- 5. 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 |
|---|---|---|
| Probiotic Bifidobacterium 1x1010 cfuAlso: Probiotic powder (1 x1010 cfu B. lactis HN019) in capsulesParticipants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. | Dietary supplement | Probiotic Bifidobacterium 1x1010 cfu |
| Probiotic Bifidobacterium 1x109 cfuAlso: Probiotic powder (1 x 109 cfu B. lactis HN019) in capsulesParticipants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day. | Dietary supplement | Probiotic Bifidobacterium 1x109 cfu |
| Placebo powder in capsulesParticipants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks. | Other | Placebo powder in capsules |
Primary outcome
Colonic transit time
Time frame: The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28
10 secondary outcomes
Patient (syn. participant) assessment of constipation symptoms (PAC-SYM)
Time frame: At days 0 and 28
Patient Assessment of Constipation Quality of Life (PAC-QoL)
Time frame: At days 0 and 28
Bowel Function Index
Time frame: At days 0 and 28
Adequate Relief of constipation (yes/no)
Time frame: At days 0 and 28
Bowel movement frequency stools per week)
Time frame: Participants will record the number of defecations per day in a daily diary during the 2-week run-in period and each day during the 4-week supplementation period
Stool consistency (Bristol Stool Scale)
Time frame: Participants will record stool consistency during the 2-week run-in period and each day during the 4-week supplementation period.
Degree of Straining (1-5 scale)
Time frame: Participants will record degree of straining during the 2-week run-in period and each day during the 4-week supplementation period.
Participant assessment of bowel emptying (yes/no)
Time frame: Participants will record sensation of complete bowel emptying during the 2-week run-in period and each day during the 4-week supplementation period.
Abdominal discomfort/bloating (1-5 scale)
Time frame: Participants will record severity of abdominal discomfort and bloating during the 2-week run-in period and each day during the 4-week supplementation period.
Overall product satisfaction (1-5 scale)
Time frame: At the end of the supplementation period (D28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
Related trials for Constipation
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
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.
Mathilde Latreille-Barbier, MD principal investigator
Eurofins Optimed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic Bifidobacterium 1x1010 cfu and Probiotic Bifidobacterium 1x109 cfu in people with Constipation and Gastrointestinal Disorder, run by Danisco Sweeteners Oy at 1 site in France.
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 11 inclusion and 12 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 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Colonic transit time (time frame: The primary outcome of Colonic Transit Time will be evaluated with abdominal x-rays on days 0 and 28). 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 7 May 2015.