Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults

NCT ID: NCT05206864

Last Updated: 2022-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-02-05

Brief Summary

The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

SBD111

Group Type: EXPERIMENTAL

Medical Food: SBD111

Intervention Type: OTHER

One capsule administered twice daily with morning and evening meals for 28 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

One capsule administered twice daily with morning and evening meals for 28 days

Interventions

Medical Food: SBD111

One capsule administered twice daily with morning and evening meals for 28 days

Intervention Type: OTHER

Placebo

One capsule administered twice daily with morning and evening meals for 28 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Written informed consent

2. Stated availability throughout entire study period and willingness to fulfill all details of the protocol

3. Age 18-70

4. Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or placebo

5. Willing to comply with protocol and report on compliance and side effects during study period

6. Body Mass Index between 18.5 and 35 kg/m2

7. Normal cardiovascular parameters, systolic blood pressure ≤ 155 mm Hg, diastolic blood pressure ≤ 95 mm Hg)

Exclusion Criteria

1. Are currently taking probiotic or prebiotic supplements, or have taken them in the past 30 days

2. Unwilling to avoid probiotics/prebiotics supplements for the duration of the study

3. Known or suspected allergies to probiotics

4. Received oral or parenteral antibiotics within 3 months of enrollment or prescribed antibiotics on day of enrollment.

5. Major surgery or endoscopy within last 3 months.

6. Subject is a smoker

7. Subject has a history of drug and/or alcohol abuse at the time of enrolment

8. Presence of any of the following:

9. Abnormal vital signs or clinically significant systems abnormalities based on screening questionnaire

10. Indwelling catheter or implanted hardware/prosthetic device or feeding tube

11. Febrile illness (oral temperature >37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline visit (first dose of study drug)

12. Active bowel leak, acute abdomen, colitis, or active GI disease or history of gastric or intestinal dysmotility, slowed transit time, variable small intestinal permeability, pancreatitis, or inflammatory bowel disease

13. History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease

14. Underlying structural heart disease or previous history of endocarditis or valve replacement

15. Immunosuppression including HIV positive, solid organ or stem cell transplant recipient, receiving any oral or parenteral immunosuppressive therapy, neutrophil count <500/mm^3, or an anticipated drop in the neutrophil count to <500/mm3

16. History of cancer excluding non-melanoma skin cancers or cancer more than 10 years ago

17. History of collagen vascular disease

18. Active TB

19. Women only - pregnant, planning on becoming pregnant within the next 2 months, breastfeeding, positive urine pregnancy test during screening or within 24 hours of first dose of study drug.

20. Screening laboratory tests greater than upper normal limit (ULN) or less than lower normal limit (LLN):

1. WBCs < LLN or > ULN

2. Neutrophils < 1500/µl (1.5 x109/L)

3. Platelets < 100 x 10³/µl (100 x 109/L)

4. Haemoglobin < 9.0 g/dl (90 g/L)

f. GFR of > 40 mL/minute g. AST > 3 x upper limit of normal h. ALT > 3 x upper limit of normal i. Total Bilirubin > 1.5 x upper limit of normal

21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer participating in the study or would make it unlikely the volunteer could complete the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hebrew SeniorLife

OTHER

Sponsor Role: collaborator

Solarea Bio, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hinda and Arthur Marcus Institute for Aging Research

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Pro00054643

Identifier Type: -

Identifier Source: org_study_id