Clinical trial NCT04448847: Mapping the MoA Behind GI Protection From Bif195
Official title: Discovering the Mechanisms of Action for the In-vivo Protection of Aspirin-induced Enteropathy by Bifidobacterium Breve Bif195 in Man - a Randomised, Double-blinded, Placebo-controlled, Cross-over Trial in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Reduction of Small Intestinal Ulceration Risk
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
First posted: 2020-06-26
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA).

The trial includes a run-in period of two weeks duration followed by a 4-week intervention period in which Bif195/placebo and ASA are co-administered. This period is followed by a 6-week wash-out period before a new 4-week period is performed with a cross-over Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo interventions are performed double-blinded in randomised order in a cross-over fashion for each subject.

Detailed description: Subjects will participate in the trial for a total duration of approximately 17 weeks including the run-in phase. Besides the screening visit, the trial will consist of 4 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. On the morning of day 4 after baseline assessments at Visit 2, all subjects will start daily intake of 300 mg ASA in combination with Bif195 or placebo in a ratio of 1:1 according to the randomisation performed at Visit 2.

At visit 2 - 5, all subjects will be biopsied from the upper small intestine and the ventricle during a gastroscopy procedure. At each of these 4 visits, 6 biopsies will be taken from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle (approximately 5 mg each). Luminal fluids will also be collected during the gastroscopy (approximately 2 ml per visit). One venous blood sample (of 20 ml per visit) will also be collected at each of these visits.

The analysis on biopsies and luminal fluid samples will include a combination of transcriptomic, microbiome, proteomics and metabolomics analysis.

Eligibility criteria: Inclusion Criteria:

* • Written informed consent

  * Healthy and without any gastrointestinal discomfort/pain or other significant symptoms
  * Age ≥ 18 and ≤ 40 years
  * Willing to abstain from any other probiotic products and/or medication known to alter gastrointestinal function throughout the participation of the trial

Exclusion Criteria:

-

Primary outcomes:
measure: The effects of daily intake of Bif195 versus placebo
timeFrame: before vs after 4 week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for Clinical Metabolic Research, Gentofte Hospital
Study officials:
affiliation: Center for Clinical Metabolic Research, Gentofte Hospital
name: Filip Knop, Professor
role: PRINCIPAL_INVESTIGATOR
References: