Side Effects of Acetylsalicylic Acid UsePhase 2PIP-DNCT03228589
The Effect of a Probiotic Strain on Aspirin-induced GI Damage.
A Phase 2 study testing probiotic strain in people with Side Effects of Acetylsalicylic Acid Use, run by Chr Hansen at 1 site in Ireland.
Trial summary
This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Side Effects of Acetylsalicylic Acid Use
- What is being tested?
- probiotic strain
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 1 siteIreland
- Study dates
- 15 Jul 2017to 4 Apr 2018
- 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 40 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 ≥ 18 - ≤ 40 years of both gender (aim of 1/3 of each gender in each arm)
- Sedentary lifestyle (weekly training load below 2 hours within endurance sports)
- 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
- 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 Aspirin
- History of H. pylori disease
- Resting diastolic blood pressure ≥ 90 mmHg
Show all 22Show fewer
- Resting systolic blood pressure ≥ 140 mmHg
- A current diagnosis of psychiatric disease
- Systemic use of antibiotics, steroids (except contraceptives) or antimicrobial medication in the last 2 months
- BMI > 27
- Daily usage of non-steroidal anti-inflammatory drugs in the last 2 months or incidental use in the last 2 weeks prior to screening (Aspirin, 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
- Lactose intolerance
- 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 2 months
- 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 PPI 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.
About this study
Official title: The Effect of 8 Weeks Intake of a Probiotic Strain on a 6 Week Aspirin-induced Intestinal Deterioration Challenge in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Two Armed, Parallel Group Trial.
This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.
Read the detailed description
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks, probiotic strain/placebo is given for two additional weeks to investigate the potential effects of the probiotic strain on intestinal healing after long-time Aspirin use.
Subjects will participate in the trial for a total duration of 10 weeks including the run-in phase. Besides the screening visit, the trial will consist of 6 visits.
After having given their written informed consent, subjects will complete 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 Aspirin and also be randomly assigned to 8 weeks daily intake of active or placebo product in a ratio of 1:1.
- Conditions
- Side Effects of Acetylsalicylic Acid Use
- Being tested
- probiotic strain, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotic strainDietary supplement
8 weeks of treatment with probiotic strain
PlaceboDietary supplement
8 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| probiotic strain | Experimental | Active arm treated with the probiotic strain for 8 weeks. Receives: Dietary Supplement: probiotic strain |
| Placebo | Placebo comparator | Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lewis score from capsule endoscopy
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment).
Measured: 8 weeks
Secondary outcomes (7)
Mucosal ulcer number
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal total ulcer number between Visit 2 (randomization) and Visit 7 (end of treatment).
Measured: 8 weeks
Pain module score of the GSRS questionnaire
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of pain module score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).
Measured: 8 weeks
Blood I-FABP concentration
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 blood I-FABP concentration.
Measured: 8 weeks
Total score of the GSRS questionnaire
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on gastrointestinal symptoms when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of total score of the GSRS questionnaire between Visit 2 (randomization) and Visit 7 (end of treatment).
Measured: 8 weeks
Mucosal red spots number
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy mucosal red spot number between Visit 2 (randomization) and Visit 7 (end of treatment).
Measured: 8 weeks
Feces Calprotectin concentration.
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve for Visit 2-Visit 7 feces Calprotectin concentration.
Measured: 8 weeks
blood Calprotectin concentration
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the blood Calprotectin concentration between Visit 2 (randomization) and Visit 7 (end of treatment).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start15 Jul 2017
- Primary completion21 Dec 2017
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Side Effects of Acetylsalicylic Acid UseStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Aspirin challenge model
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chr Hansen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
- Investigators
- Martin Buckley, Dr, Principal investigator, GI Physiology Laboratory, Mercy University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03228589
- Sponsor's protocol ID
- HND-GI-025
- Acronym
- PIP-D
- Status last verified
- May 2018
- First submitted
- 4 Jul 2017
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mortensen B, Murphy C, O'Grady J, Lucey M, Elsafi G, Barry L, Westphal V, Wellejus A, Lukjancenko O, Eklund AC, Nielsen HB, Baker A, Damholt A, van Hylckama Vlieg JET, Shanahan F, Buckley M. Bifidobacteriumbreve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers. Gastroenterology. 2019 Sep;157(3):637-646.e4. doi: 10.1053/j.gastro.2019.05.008. Epub 2019 May 13.
PubMed 31095949
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 8 Weeks Intake of a Probiotic Strain on a 6 Week Aspirin-induced Intestinal Deterioration Challenge in Healthy Volunteers - a Randomized, Double-blind, Placebo-controlled, Two Armed, Parallel Group Trial.
- ClinicalTrials.gov ID
- NCT03228589
- Acronym / sponsor ID
- PIP-D / HND-GI-025
- Conditions
- Side Effects of Acetylsalicylic Acid Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Chr HansenIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 15 Jul 2017 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 25 Jul 2017 (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.
This trial is a single-site, randomised, double-blind, placebo-controlled, two-armed, parallel-group trial in healthy, adult volunteers. The trial will investigate the effect of daily intake of a probiotic strain versus placebo when co-administered to daily intake of 300mg of Aspirin. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.
Detailed description
The trial includes a run-in period of two weeks duration followed by a six weeks intervention period where a probiotic strain/placebo and Aspirin is co-administered. After the 6 weeks, probiotic strain/placebo is given for two additional weeks to investigate the potential effects of the probiotic strain on intestinal healing after long-time Aspirin use.
Subjects will participate in the trial for a total duration of 10 weeks including the run-in phase. Besides the screening visit, the trial will consist of 6 visits.
After having given their written informed consent, subjects will complete 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 Aspirin and also be randomly assigned to 8 weeks daily intake of active 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
- Model description
- Aspirin challenge model
| Arm | Type | Receives |
|---|---|---|
| probiotic strain | Experimental | Dietary Supplement: probiotic strainActive arm treated with the probiotic strain for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Written informed consent
- Healthy and without any gastrointestinal discomfort/pain symptoms
- Age ≥ 18 - ≤ 40 years of both gender (aim of 1/3 of each gender in each arm)
- Sedentary lifestyle (weekly training load below 2 hours within endurance sports)
- 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 (22 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 Aspirin
- History of H. pylori disease
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 strain8 weeks of treatment with probiotic strain | Dietary supplement | probiotic strain |
| Placebo8 weeks of treatment | Dietary supplement | Placebo |
Primary outcome
Lewis score from capsule endoscopy
Time frame: 8 weeks
The effect of 8 weeks oral supplementation of probiotic strain versus placebo on small intestinal mucosa damage when co-administered to a 6 week Aspirin challenge measured as the area-under-the-curve of the capsule endoscopy Lewis score between Visit 2 (randomization) and Visit 7 (end of treatment).
7 secondary outcomes
Mucosal ulcer number
Time frame: 8 weeks
Pain module score of the GSRS questionnaire
Time frame: 8 weeks
Blood I-FABP concentration
Time frame: 8 weeks
Total score of the GSRS questionnaire
Time frame: 8 weeks
Mucosal red spots number
Time frame: 8 weeks
Feces Calprotectin concentration.
Time frame: 8 weeks
blood Calprotectin concentration
Time frame: 8 weeks
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 3 May 2018.
- Derived from this study: PubMed 31095949Mortensen B, Murphy C, O'Grady J, Lucey M, Elsafi G, Barry L, Westphal V, Wellejus A, Lukjancenko O, Eklund AC, Nielsen HB, Baker A, Damholt A, van Hylckama Vlieg JET, Shanahan F, Buckley M. Bifidobacteriumbreve Bif195 Protects Against Small-Intestinal Damage Caused by Acetylsalicylic Acid in Healthy Volunteers. Gastroenterology. 2019 Sep;157(3):637-646.e4. doi: 10.1053/j.gastro.2019.05.008. Epub 2019 May 13.
- Individual participant dataSharing planned: No
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Ischemic Heart Disease, Ischemic Heart Disease Chronic
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.
Martin Buckley, Dr principal investigator
GI Physiology Laboratory, Mercy University Hospital
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 strain in people with Side Effects of Acetylsalicylic Acid Use, run by Chr Hansen at 1 site in Ireland.
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 5 inclusion and 22 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 3 May 2018. 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 Ireland. 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?
Lewis score from capsule endoscopy (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03228589, which also lists 1 linked publication.
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 3 May 2018.