Anaerostipes caccae CLB101TM️ is a next-generation probiotic isolated from healthy humans. It was shown to be in decreased abundance in people with protein-based food sensitivities/allergies. CLB101TM️ is different from most commercially available probiotics in that it directly produces butyrate. Butyrate is a naturally occurring small molecule found in the gut of healthy individuals, and it has been shown to provide clinical benefits including strengthening the gut lining, providing immune health, and supporting a balanced microbiome. The rationale for developing CLB101TM️ is to provide a probiotic that generates butyrate in the targeted intestinal locations where it can optimally benefit cells that line the gut.
The rationale for this study is to observe the impact of a probiotic supplement called CLB101TM️ on gut health in overweight individuals with moderate to severe gastrointestinal discomfort. Additionally, the study aims to observe the impact of the probiotic product on gastrointestinal symptoms, blood parameters, gut microbiota, as well as its impact on intestinal permeability via activities and technologies that can successfully and effectively be completed and utilized in a home setting. A consumer-driven, decentralized observational clinical research study is therefore well-suited for examining the effects of this probiotic product in this population. The study team will examine the outcomes in a broad age-range of adults who have chosen to try this product. The study will incorporate participant reported outcome questionnaires and surveys and at-home stool collection. There is no "doctor-patient" relationship as part of this research since the participant as a consumer is making the informed choice to take the product and take part in the observational process with self-reported measures and at-home sample collection. Findings from this study will contribute knowledge toward the tolerability and formulation of the probiotic product and the design of future studies. This trial includes a parallel sub-study limited to 30 participants. Eligibility criteria for the sub-study are identical to the main cohort, with the exception that biospecimen collection is waived.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
48
CLB101™️ is a probiotic isolated from healthy humans.
Placebo control.
Sub-study: CLB101™️ is a probiotic isolated from healthy humans.
Sub-study: Placebo control.
People Science
Los Angeles, California, United States
Adverse Events
The primary outcome measure is to observe the safety and tolerability of the study product. Assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product/placebo use period.
Time frame: 6 weeks
Gastrointestinal Symptoms
A secondary outcome measure will be to assess the impact of the study product. on gastrointestinal symotoms. This will be measured by assessing the change from in Gastrointestinal Symptom Questionnaire score between study product and placebo. The instruments uses a likert scale: Absent - I did not have this symptom at all Mild - I had this symptom occasionally, but it did not really bother me Moderate - I had this symptom often, it bothered me quite a bit Severe - I had this symptom very often, it bothered me a great deal), with a lower value indicating a better outcome
Time frame: 6 Weeks
Gastrointestinal Symptoms
A secondary outcome measure is to assess the impact of the study product on gastrointestinal symptoms by assessing the change in average scores of gastrointestinal symptoms (i.e., flatulence, bloating, abdominal discomfort, stool consistency/ regularity with modified scale assessment, constipation) between placebo and study product group as measured by a 10-point VAS with 0 being absent and 10 being severe
Time frame: 6 Weeks
Blood biomarkers
Another secondary outcome is to evaluate the change from baseline in blood blood biomarkers including serum LPS- BP, fecal Calprotectin, Zonulin, Lactoferrin, Butyrate, and ALT/AST at the end of Week 4 between placebo and study product groups.
Time frame: 6 weeks
Gut microbiome
This will be evaluated by looking at the changes from baseline in gut microbiome composition and quantity of A. caccae at Week 4 as analyzed by sequencing and qPRC of stool specimens between study product and placebo groups
Time frame: 6 Weeks
Intestinal permeability.
Another secondary outcome measure is to evaluate the change from baseline in intestinal permeability at Week 4 as measured by Intestinal Permeability assessment/Leaky Gut Test between placebo and study product groups.
Time frame: 6 weeks
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