Reduction of Small Intestinal Ulceration RiskPIP-LNCT03910322
The Effect of a Probiotic Strain on Aspirin-induced GI Damage
A study testing Bif195 in people with Reduction of Small Intestinal Ulceration Risk, run by Chr Hansen at 1 site in United States.
Trial summary
The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Reduction of Small Intestinal Ulceration Risk
- What is being tested?
- Bif195
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2019to 1 Dec 2019
- Phase
- Interventional
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Healthy and without any gastrointestinal discomfort/pain symptoms
- Age 40-60 years of both genders (aim of minimum 1/3 of each gender in each arm)
- Willing and able to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Who cannot join
- Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy)
- History of peptic ulcer disease
- Any known bleeding disorder
- Allergy to ASA
- Resting diastolic blood pressure ≥ 95 mmHg
- Resting systolic blood pressure ≥ 150 mmHg
Show all 19Show fewer
- A current diagnosis of psychiatric disease
- Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
- Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (ASA, Ibuprofen, Diclofenac, Naproxen, Celecoxib, Mefenamic acid, Etoricoxib, Indometacin)
- Usage of medications, except contraceptives, in the last 2 weeks prior to screening
- Diagnosed inflammatory gastrointestinal disease and/or irritable bowel syndrome
- Any other disease that, by the Investigators discretion, could interfere with the intestinal barrier function of the subject
- Participation in other clinical trials in the past 2 months prior to screening
- Regular use of probiotics in the last month
- Smoking and/or frequent use of other nicotine products
- Desire and/or plans on changing current diet and/or exercise regime during the participation of this trial
- Use of laxatives, anti-diarrheals, anti-cholinergics and proton pump inhibitors within last 2 months prior to screening
- Use of immunosuppressant drugs within last 4 weeks prior to screening
- For Women: Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Atlantia Food Clinical Trials
Chicago, Illinois, 60611
About this study
Official title: The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.
The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.
Read the detailed description
This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA).
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits.
After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 300mg ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195) or placebo product in a ratio of 1:1:1.
- Being tested
- Bif195, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bif195Dietary supplement
Two different doses of the bacterial strain Bif195 is compared to placebo
PlaceboDietary supplement
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo arm. Similar trial product, but without Bif195 bacteria Receives: Dietary Supplement: Placebo |
| Low-dose Bif195 | Experimental | Active trial product with minimum 15 billion CFU daily dose Receives: Dietary Supplement: Bif195 |
| High-dose Bif195 | Experimental | Active trial product with minimum 50 billion CFU daily dose Receives: Dietary Supplement: Bif195 |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary endpoint - Lewis score high dose Bif195 vs Placebo
The effect of high-dose Bif195 versus placebo on small intestinal mucosal damage during a 6-week ASA challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start19 Aug 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Why it stopped: Decision made by Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reduction of Small Intestinal Ulceration RiskStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Eamonn Quigley, Professor, Principal investigator, Houston Methodist Gastroenterology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910322
- Sponsor's protocol ID
- HND-GI-035
- Acronym
- PIP-L
- Status last verified
- Aug 2019
- First submitted
- 9 Apr 2019
- Last updated
- 26 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Intake of Two Different Doses of Bif195 on Small-intestinal Damage Induced by Acetylsalicylic Acid- a Randomized, Double-blind, Placebo-controlled, Three-armed, Parallel Group Trial in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03910322
- Acronym / sponsor ID
- PIP-L / HND-GI-035
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision made by Sponsor
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 19 Aug 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 10 Apr 2019 (actual)
- 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.
The primary objective of this trial is to investigate if a daily dose of minimum 50 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an acetylsalicylic acid challenge model as assessed by video capsule endoscopy in a healthy US population aged 40 - 60 years.
Detailed description
This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA).
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered.
Subjects will participate in the trial for a total duration of 8 weeks including the run-in phase. Besides the screening visit, the trial will consist of 5 visits.
After having given their written informed consent, subjects will complete the screening procedures to evaluate their eligibility for participation in the trial and complete a run-in period of two weeks duration to washout possible pre-trial probiotics and/or use of medication. After baseline assessments at Visit 2, subjects will start daily intake of 300mg ASA and also be randomly assigned to 6-weeks daily intake of low or high-dose active (Bif195) or placebo product in a ratio of 1:1:1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This trial is a single-site, randomized, double-blind, placebo-controlled, three-armed, parallel-group trial in healthy volunteers aged 40 - 60 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 in two different doses or placebo when co-administered to daily intake of 300mg of Acetylsalicylic Acid (ASA). The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and ASA is co-administered.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo arm. Similar trial product, but without Bif195 bacteria |
| Low-dose Bif195 | Experimental | Dietary Supplement: Bif195Active trial product with minimum 15 billion CFU daily dose |
| High-dose Bif195 | Experimental | Dietary Supplement: Bif195Active trial product with minimum 50 billion CFU daily dose |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent
- Healthy and without any gastrointestinal discomfort/pain symptoms
- Age 40-60 years of both genders (aim of minimum 1/3 of each gender in each arm)
- Willing and able to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Key exclusion criteria (19 listed)
- Abdominal surgery which, as judged by the investigator, might affect the GI function (except appendectomy and cholecystectomy)
- History of peptic ulcer disease
- Any known bleeding disorder
- Allergy to ASA
- Resting diastolic blood pressure ≥ 95 mmHg
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 |
|---|---|---|
| Bif195Two different doses of the bacterial strain Bif195 is compared to placebo | Dietary supplement | High-dose Bif195, Low-dose Bif195 |
| PlaceboPlacebo | Dietary supplement | Placebo |
Primary outcome
primary endpoint - Lewis score high dose Bif195 vs Placebo
Time frame: 6 weeks
The effect of high-dose Bif195 versus placebo on small intestinal mucosal damage during a 6-week ASA challenge measured as the area-under-the-curve of the Lewis scores obtained from all video capsule endoscopies between Visit 2 (randomization) and Visit 6 (end of treatment).
Results and safety
The study was stopped early (reason given: Decision made by Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Individual participant dataSharing planned: No
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.
Eamonn Quigley, Professor principal investigator
Houston Methodist Gastroenterology Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bif195 in people with Reduction of Small Intestinal Ulceration Risk, run by Chr Hansen at 1 site 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 4 inclusion and 19 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: stopped early, as of the sponsor's last update on 26 Jun 2020. 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 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.
Are results available for this study?
The study was stopped early (reason given: Decision made by Sponsor). Results are not available in the source record.
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?
primary endpoint - Lewis score high dose Bif195 vs Placebo (time frame: 6 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 26 Jun 2020.