NCT04448847

Mapping the MoA Behind GI Protection From Bif195

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Reduction of Small Intestinal Ulceration Risk

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bif195	Active trial product with minimum 100 billion CFU daily dose
OTHER	Placebo	Placebo similar to trial product but without Bif195

Timeline

• Start date: 2020-06-08
• Primary completion: 2021-01-12
• Completion: 2021-01-12
• First posted: 2020-06-26
• Last updated: 2023-04-24

Locations

1 site across 1 country: Denmark