Reduction of Small Intestinal Ulceration RiskPIP-INCT04447924
The Effect of a Probiotic Strain on Ibuprofen-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
To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population. Read more about this study
- Who is it for?
- Ages 18 to 40 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
- 177 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 10 Jun 2021
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Healthy and without any gastrointestinal pain or other significant symptoms
- Age 18 - 40 years
- Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Who cannot join
- -
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 Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.
To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population.
Read the detailed description
This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake of 800mg of Ibuprofen.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and Ibuprofen 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 800mg of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo product in a ratio of 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
Daily intake of Bif195 dietary supplement
PlaceboOther
Daily intake of Placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo arm | Placebo comparator | Placebo arm. Similar trial product, but without Bif195 bacteria Receives: Other: Placebo |
| Bif195 arm | Experimental | Active trial product with minimum 15 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.
Lewis score area-under-the-curve for Bif195 vs Placebo
The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen 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 posted25 Jun 2020
- Study start22 Jun 2020
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eamonn Quigley, Professor, Principal investigator, Houston Methodist Gastroenterology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447924
- Sponsor's protocol ID
- HND-GI-038
- Acronym
- PIP-I
- Status last verified
- Aug 2021
- First submitted
- 24 Jun 2020
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- 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 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Daily Intake of Bifidobacterium Breve Bif195 on Small-intestinal Damage Induced by Ibuprofen - a Randomized, Double-blind, Placebo-controlled Trial in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT04447924
- Acronym / sponsor ID
- PIP-I / HND-GI-038
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 25 Jun 2020 (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.
To investigate if a daily dose of minimum 15 billion CFU of Bif195 reduces the risk of small-intestinal tissue damage in an Ibuprofen challenge model as assessed by video capsule endoscopy in a healthy US population.
Detailed description
This trial is a single-site, randomized, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy volunteers aged 18 - 40 years. The trial will investigate the effect of daily intake of the probiotic strain Bif195 or placebo when co-administered to daily intake of 800mg of Ibuprofen.
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where Bif195/placebo and Ibuprofen 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 800mg of Ibuprofen and also be randomly assigned to 6-weeks daily intake of Bif195 or placebo product in a ratio of 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo arm | Placebo comparator | Other: PlaceboPlacebo arm. Similar trial product, but without Bif195 bacteria |
| Bif195 arm | Experimental | Dietary Supplement: Bif195Active trial product with minimum 15 billion CFU daily dose |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Written informed consent
- Healthy and without any gastrointestinal pain or other significant symptoms
- Age 18 - 40 years
- Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Bif195Daily intake of Bif195 dietary supplement | Dietary supplement | Bif195 arm |
| PlaceboDaily intake of Placebo | Other | Placebo arm |
Primary outcome
Lewis score area-under-the-curve for Bif195 vs Placebo
Time frame: 6 weeks
The effect of Bif195 versus placebo on small intestinal mucosal damage during a 6-week Ibuprofen 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 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 26 Aug 2021.
- 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 1 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 26 Aug 2021. 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 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?
Lewis score area-under-the-curve for 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 Aug 2021.