Food Trial to Evaluate the Kinetics of the Medical Foods SBD111 and SBD121 Persistence in Healthy Adults

NCT06614166 | Active Not Recruiting

• 1 other identifier: Pro00078728
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, open-label, trial in healthy volunteers. Trial participants will be given a medical food product (combination of probiotics and prebiotics) called SBD111 or SBD121 for seven days and microbial abundance in feces will be measured during that time and for four weeks following administration.

Conditions

Product Persistence in GI Tract; Kinetics; Rheumatoid Arthritis (RA); Bone Density

Outcome Measures

Primary Outcomes (1)

• Persistence of SBD111 and SBD121 microbes in fecal samples

  DNA isolated from fecal swabs will be used to determine the persistence of SBD111 and SBD121 microbes in stool samples up to 28 days following twice-daily oral administration of SBD111 or SBD121 to healthy adults.

  5 weeks

Secondary Outcomes (1)

• Microbial Community Structure Changes

  5 weeks

Other Outcomes (1)

• Microbe Viability

  2 weeks

Study Arms (2)

Synbiotic Medical Food SBD111

EXPERIMENTAL

Probiotic comprised of three lactic acid bacteria and one yeast

Other: SBD111 Probiotic Medical Food

Synbiotic Medical Food SBD121

EXPERIMENTAL

Probiotic comprised of three lactic acid bacteria and one bacillus

Other: SBD121 Probiotic Medical Food

Interventions

SBD111 Probiotic Medical Food OTHER

Medical food comprised of probiotics and prebiotic fibers

Synbiotic Medical Food SBD111

SBD121 Probiotic Medical Food OTHER

Probiotic medical food comprised of three lactic acid bacteria and one bacillus

Synbiotic Medical Food SBD121

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provide written informed consent.
• Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
• Age 18-64 years.
• Be in general good health as determined by a screening evaluation within 30 days of the first dose of SBD111 or SBD121.
• Willing to comply with protocol and report on compliance and side effects during study period.
• Body Mass Index between 18.5 and 35 kg/m2.

You may not qualify if:

• Are currently taking probiotic or prebiotic supplements or have taken them in the past 30 days.
• Unwilling to avoid probiotics/prebiotics supplements for the duration of the study.
• Known or suspected allergies to probiotics, maltodextrin, or berries.
• Received oral or parenteral antibiotics within 3 months of enrollment or prescribed antibiotics on the day of enrollment.
• Major surgery on the intestines or endoscopy within last 3 months.
• Current smoker.
• History of drug and/or alcohol abuse at the time of enrollment.
• Presence of any of the following:
• Abnormal vital signs or clinically significant systems abnormalities based on screening questionnaire.
• Indwelling catheter or implanted hardware/prosthetic device or feeding tube.
• a. Excluding joint replacements
• Febrile illness (oral temperature \>37 degrees Celsius) or one or more episodes of diarrhea within 72 hours of baseline (first dose of study article).
• 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.
• History of Hepatitis B or Hepatitis C infections, cirrhosis, or chronic liver disease.
• Underlying structural heart disease or previous history of endocarditis or valve replacement.

Sponsors & Collaborators

• Solarea Bio, Inc: lead

Study Sites (1)

Solarea Bio Inc

Waltham, Massachusetts, 02453-8400, United States

Location

Related Publications (3)

• Easson DD Jr, Murphy VA, Ballok AE, Soto-Giron MJ, Miller KJ, Charbonneau MR, Schott EM, Greene T, Rodricks J, Toledo GV. Food safety assessment and 28-day toxicity study of the synbiotic medical food consortium SBD121. Food Chem Toxicol. 2024 Sep;191:114839. doi: 10.1016/j.fct.2024.114839. Epub 2024 Jun 26.

  PMID: 38942165 BACKGROUND

• Easson DD Jr, Murphy VA, Ballok AE, Soto-Giron MJ, Schott EM, Rodricks J, Toledo GV. Food safety assessment and toxicity study of the synbiotic consortium SBD111. Food Chem Toxicol. 2022 Oct;168:113329. doi: 10.1016/j.fct.2022.113329. Epub 2022 Aug 7.

  PMID: 35948142 BACKGROUND

• Lawenius L, Gustafsson KL, Wu J, Nilsson KH, Moverare-Skrtic S, Schott EM, Soto-Giron MJ, Toledo GV, Sjogren K, Ohlsson C. Development of a synbiotic that protects against ovariectomy-induced trabecular bone loss. Am J Physiol Endocrinol Metab. 2022 Apr 1;322(4):E344-E354. doi: 10.1152/ajpendo.00366.2021. Epub 2022 Feb 14.

  PMID: 35156423 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Alicia E Ballok, PhD

  Solarea Bio, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 26, 2024
• Study Start: June 14, 2024
• Primary Completion: May 23, 2025
• Study Completion: June 28, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)