NCT03228589

Brief 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. The objective is to investigate the ability of the probiotic strain to attenuate and/or reverse Aspirin-induced deterioration of the small intestine.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
109

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

July 15, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

5 months

First QC Date

July 4, 2017

Last Update Submit

May 1, 2018

Conditions

Side Effects of Acetylsalicylic Acid Use

Outcome Measures

Primary Outcomes (1)

  • 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).

    8 weeks

Secondary Outcomes (7)

  • Mucosal ulcer number

    8 weeks

  • Pain module score of the GSRS questionnaire

    8 weeks

  • Blood I-FABP concentration

    8 weeks

  • Total score of the GSRS questionnaire

    8 weeks

  • Mucosal red spots number

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

probiotic strain

EXPERIMENTAL

Active arm treated with the probiotic strain for 8 weeks.

Dietary Supplement: probiotic strain

Placebo

PLACEBO COMPARATOR

Placebo arm treated with placebo capsules (identical to active product capsule besides the bacteria) for 8 weeks.

Dietary Supplement: Placebo

Interventions

probiotic strainDIETARY_SUPPLEMENT

8 weeks of treatment with probiotic strain

probiotic strain
PlaceboDIETARY_SUPPLEMENT

8 weeks of treatment

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlantia Food Clnical Trials

Cork, T23 R50R, Ireland

Location

Related Publications (1)

  • 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.

    PMID: 31095949DERIVED

Study Officials

  • Martin Buckley, Dr

    GI Physiology Laboratory, Mercy University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Aspirin challenge model
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2017

First Posted

July 25, 2017

Study Start

July 15, 2017

Primary Completion

December 21, 2017

Study Completion

April 4, 2018

Last Updated

May 3, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)