NCT07336615

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2025Jun 2026

Study Start

First participant enrolled

October 9, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2026

Expected
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

November 18, 2025

Last Update Submit

March 19, 2026

Conditions

GastrointestinalOverweight , Obesity

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks

Secondary Outcomes (5)

  • Gastrointestinal Symptoms

    6 Weeks

  • Gastrointestinal Symptoms

    6 Weeks

  • Blood biomarkers

    6 weeks

  • Gut microbiome

    6 Weeks

  • Intestinal permeability.

    6 weeks

Study Arms (4)

Study product CLB101

EXPERIMENTAL

Study group will receive the study product CLB101

Dietary Supplement: CLB101™️

Placebo control

PLACEBO COMPARATOR

Placebo control group will only receive the placebo until the end of study.

Other: Placebo

Sub-Study CLB101 Arm

EXPERIMENTAL

Study group will receive the study product CLB101

Dietary Supplement: CLB101™️

Sub-Study Placebo Control

PLACEBO COMPARATOR

Placebo control group will only receive the placebo until the end of study.

Other: Placebo control

Interventions

CLB101™️DIETARY_SUPPLEMENT

CLB101™️ is a probiotic isolated from healthy humans.

Study product CLB101
PlaceboOTHER

Placebo control.

Placebo control
Placebo controlOTHER

Sub-study: Placebo control.

Sub-Study Placebo Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and Female
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18-65 years old, inclusive
  • Has self-reported moderate to severe gastrointestinal or digestive symptoms, such as abdominal pain, bloating, flatulence, constipation, or diarrhea.
  • Has a Gastrointestinal Symptom Rating Scale (GSRS) score between 4-7.
  • Has a Body Mass Index (BMI) \>27 but \<35.0 kg/m\^2.
  • Willingness to refrain from taking probiotics or prebiotics during the study period.
  • Interested in understanding more about their gut health and the use of probiotic products.
  • If taking any OTC or prescription medications for anxiety (e.g. magnesium, anticholinergics, Buspirone, Tricyclics, MAOIs,) or other class of medication for anxiety, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study.
  • If using any cannabis-containing products, must be on a stable dose regimen for at least 4 weeks prior to randomization and throughout the course of the study.
  • If using any nicotine-containing products, must be on a stable regimen for at least 4 weeks prior to randomization and throughout the course of the study.
  • Willing to practice a reliable method of contraception for the duration of the study
  • In good general health at the time of screening (Investigator discretion).
  • Able to read and understand English.
  • Able to read, understand, and provide informed consent.
  • Able to use a personal smartphone device and download Chloe by People Science.
  • Able to receive shipment of the product at an address within the United States and use at-home refrigerator and/or freezer.
  • +1 more criteria

You may not qualify if:

  • Participants that do not have a personal smartphone, internet access, or unwilling to download Chloe.
  • Participants who are currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).
  • Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
  • Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.
  • Participants using immunosuppressive medications, systemic steroids, antifungals, NSAIDs or other medications known to significantly impact gastrointestinal function or microbiota.
  • Participants with a clinical diagnosis of any gastrointestinal illness, including but not limited to:
  • Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • Gastroesophageal reflux disease (GERD)
  • Gastric or duodenal ulcers
  • Celiac disease
  • Diverticular disease
  • Chronic pancreatitis
  • Gastroparesis
  • Severe liver disease (e.g., cirrhosis, hepatitis, NAFLD acceptable)
  • Gallbladder disease (e.g., cholecystitis, cholelithiasis)
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

People Science

Los Angeles, California, 90034, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Naoh Craft, MD

    People Science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Study team
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

January 13, 2026

Study Start

October 9, 2025

Primary Completion

April 26, 2026

Study Completion (Estimated)

June 26, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Locations

US(1)