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GastrointestinalNCT07336615

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals

A study testing CLB101™️ in people with Gastrointestinal and Overweight , Obesity, run by ClostraBio Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Gastrointestinal, Overweight , Obesity
What is being tested?
CLB101™️
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
85 participants
Where
1 siteUnited States
Study dates
9 Oct 2025to 23 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • Able to complete study assessments including two stool sample collections, two blood sample collections, two intestinal permeability urine tests, and a food diary over the course of up to 12 weeks.

Who cannot join

  • 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:
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  • 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)
  • Gastrointestinal cancer (Colorectal, Intestinal, Stomach, Liver, Gallbladder)
  • Participants with a known or suspected gastrointestinal infection, such as:
  • Clostridium difficile infection
  • Helicobacter pylori infection
  • Parasitic infections (e.g., Giardia, Cryptosporidium)
  • Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.
  • Participants with a history of gastrointestinal bleeding or perforation.
  • Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
  • Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding
  • Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
  • Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
  • Known hypersensitivity or previous allergic reaction to probiotics, microcrystalline cellulose, vegetarian capsules, silica, or magnesium stearate.
  • Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
  • Consume more than 2 (two) alcoholic drinks per day.
  • Cannabis or nicotine use that is weekly or more frequent.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • People Science

    Los Angeles, California, 90034

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
CLB101™️, Placebo, Placebo control
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CLB101™️Dietary supplement

    CLB101™️ is a probiotic isolated from healthy humans.

  • PlaceboOther

    Placebo control.

  • CLB101™️Dietary supplement

    Sub-study: CLB101™️ is a probiotic isolated from healthy humans.

  • Placebo controlOther

    Sub-study: Placebo control.

Study groups in NCT07336615
Study groupRoleWhat they receive
Study product CLB101ExperimentalStudy group will receive the study product CLB101
Receives: Dietary Supplement: CLB101™️
Placebo controlPlacebo comparatorPlacebo control group will only receive the placebo until the end of study.
Receives: Other: Placebo
Sub-Study CLB101 ArmExperimentalStudy group will receive the study product CLB101
Receives: Dietary Supplement: CLB101™️
Sub-Study Placebo ControlPlacebo comparatorPlacebo control group will only receive the placebo until the end of study.
Receives: Other: Placebo control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 weeks

Secondary outcomes (5)

  1. 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

    Measured: 6 Weeks

  2. 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

    Measured: 6 Weeks

  3. 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.

    Measured: 6 weeks

  4. 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

    Measured: 6 Weeks

  5. 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.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2026
  2. Study start9 Oct 2025
  3. Primary completion23 Jun 2026
  4. Study completion23 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07336615
Sponsor's protocol ID
PS22
Status last verified
Aug 2026
First submitted
18 Nov 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: This will need to be discussed internally.

Questions about this trial

What is this clinical trial studying?

A study testing CLB101™️ in people with Gastrointestinal and Overweight , Obesity, run by ClostraBio Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07336615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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