Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2023-02-20
2023-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Cohort A Dose 1
Oral, daily administration of BL-001 Dose 1 or Placebo randomized 3:1 (BL-001: Placebo)
BL-001
Live biological product BL-001
Placebo
Placebo
Cohort B Dose 2
Oral, daily administration of BL-001 Dose 2 or Placebo randomized 3:1 (BL-001: Placebo)
BL-001
Live biological product BL-001
Placebo
Placebo
Cohort C Dose 3
Oral, daily administration of BL-001 Dose 3 or Placebo randomized 3:1 (BL-001: Placebo)
BL-001
Live biological product BL-001
Placebo
Placebo
Cohort D Dose 4
Oral, daily administration of BL-001 Dose 4 or Placebo randomized 3:1 (BL-001: Placebo)
BL-001
Live biological product BL-001
Placebo
Placebo
Interventions
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BL-001
Live biological product BL-001
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
2. Sex and Age: men/women, 18-55 years old inclusive
3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive
4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position
5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
6. Contraception and fertility (women only): women of child-bearing potential must be using at least one of the protocol defined and reliable methods of contraception
Exclusion Criteria
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Bowel movements: on average ≥3 stools per day or \<3 stools per week
4. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness
5. Allergy: ascertained or presumptive hypersensitivity to the formulation's ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study
6. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study
7. Gastrointestinal: evidence of acute or chronic gastrointestinal disorders
8. Medications and probiotics: probiotics, nutraceuticals, and medications, including over the counter medications and herbal remedies for 2 weeks and antibiotics for 3 months before the start of the study. Hormonal contraceptives for women will be allowed
18 Years
55 Years
ALL
Yes
Sponsors
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Bloom Science
INDUSTRY
Responsible Party
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Principal Investigators
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Paolo Baroldi
Role: STUDY_DIRECTOR
Bloom Science
Locations
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CROSS Research S.A.
Arzo, Canton Ticino, Switzerland
Countries
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Other Identifiers
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BL-001-1001
Identifier Type: -
Identifier Source: org_study_id
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