Healthy AdultsNCT07566884
Safety and Tolerance of a Novel Three-Strain Probiotic in Healthy Adults
A study testing Three-Strain Probiotic in people with Healthy Adults, run by Pendulum Therapeutics at 1 site in Ireland.
Trial summary
This Phase I \& II study evaluates the safety and tolerability of 8 weeks of daily supplementation with high-dose versus standard-dose of a novel three-strain probiotic. Safety and tolerability will be assessed by adverse events, safety blood profile, and vital signs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Three-Strain Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIreland
- Study dates
- 23 Sep 2024to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- To be eligible for inclusion, the Participant must fulfill all the following criteria:
- Be able to give written informed consent.
- Be between 18 and 65 years, inclusive.
- Has a BMI: Phase I ≤29.9kg/m2. Phase II ≤34.9kg/m2.
- Mean total food craving score (FCI-UK) of ≥2.5 at screening visit. (Phase I only) 5. Stable weight for the past 30 days (defined as ± 2.3kg).
- 6. Willing to consume the Study Product daily for the duration of the study.
Who cannot join
- Participants will be excluded from the study if they meet any of the following criteria:
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Complete abstinence from intercourse two weeks prior to administration of the Study Product, throughout the clinical study, until the completion of follow-up procedures or for two weeks following discontinuation of the Study Product in cases where Participant discontinues the study prematurely. (Participants utilising this method must agree to use an alternate method of contraception if they should become sexually active and will be queried on whether they have been abstinent in the preceding two weeks when they present to the clinic for the final visit).
- Has a male sexual partner who is surgically sterilised prior to the Screening Visit and is the only male sexual partner for that Participant.
- Sexual partner(s) is/are exclusively female.
Show all 17Show fewer
- Use of acceptable method of contraception, such as a spermicide, mechanical barrier (e.g., male condom, female diaphragm), tubal ligation, or contraceptive pill. The Participant must be using this method for at least one week prior to and one week following the end of the study.
- Use of any intrauterine device (IUD) or contraceptive implant. The Participant must have the device inserted at least two weeks prior to the first screening visit, throughout the study, and two weeks following the end of the study.
- Has food allergies or other issues with foods that would preclude intake of the Study Products.
- Known hypersensitivity to any component of the probiotic used in the study (Clostridium butyricum WB-STR-0006, Akkermansia muciniphila WB-STR-0001, Bifidobacterium infantis, chicory inulin, microcrystalline cellulose, l-leucine, hypromellose (vegetarian capsule), silica)
- Known hypersensitivity or allergy to any component of the meal product used in the meal challenge (allergens: milk and soy)
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include: a. Gastrointestinal condition (including GI bleeding in the past 3 months) b. Major gastrointestinal surgery or explorations (cholecystectomy and appendectomy are allowed) c. Cancer (in the past 1 year) d. Active autoimmune condition e. Cardiovascular disease (in the past 3 months) 5. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include: a. Oral antibiotics or Antifungals (in the past 1 month) b. Medications impacting gut motility (in the 2 weeks prior to baseline) c. GLP-1 receptor agonists (in the past 6 months) d. Sulfonylureas (in the past 6 months) e. Proton Pump Inhibitors (in the past 1 month) f. Laxatives (in the past 1 month)
- 6. Current or recent (in the past 1 month) use of prohibited nutritional or non-nutritional supplements, including:
- Probiotics/Prebiotics
- Fibre supplements 7. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- 8. Participants may not be receiving treatment involving experimental drugs/supplements. If the Participant has been in a recent experimental study, these must have been completed not less than 90 days for drugs and 30 days for supplements prior to this study.
- 9. Current participation or planned participation in a weight loss program during the study period 10. Known hypersensitivity to >4 first-line antimicrobial therapies against Akkermansia muciniphila: Penicillin, Piperacillin, Amoxicillin, Ampicillin, Tetracycline 11. Known hypersensitivity to >4 first-line antimicrobial therapies against Clostridium butyricum: Penicillin, Piperacillin, Amoxicillin, Ampicillin, Tetracycline, Vancomycin, Cefoxitin 12. Known hypersensitivity to >4 first-line antimicrobial therapies against Bifidobacterium infantis Bi-26TM: Gentamicin, Kanamycin, Streptomycin, Tetracycline, Erythromycin, Clindamycin, Ampicillin, Vancomycin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Phase Study on the Safety and Tolerance of a Novel Probiotic in Healthy Adults: Open-Label and Double-Blind, Placebo-Controlled Study
This Phase I \& II study evaluates the safety and tolerability of 8 weeks of daily supplementation with high-dose versus standard-dose of a novel three-strain probiotic. Safety and tolerability will be assessed by adverse events, safety blood profile, and vital signs. Secondary assessments include food cravings, gastrointestinal outcomes, sleep, quality of life, subjective ratings of hunger and satiety and associated hormone responses including plasma GLP-1, glucose, and insulin.
Read the detailed description
A Two-Phase Study safety and tolerance study:
Phase I: Open-Label Study Phase II: Randomised Double-Blind, Placebo-Controlled Study
- Conditions
- Healthy Adults
- Being tested
- Three-Strain Probiotic, Phase 2 - Placebo
- Keywords
- Probiotics, Akkermansia Muciniphila, Food Cravings, GLP-1, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Strain ProbioticDietary supplement
≥ 500 million AFU of Clostridium butyricum strain WB-STR-0006, Akkermansia muciniphila strain WB-STR-0001, Bifidobacterium infantis Bi-26TM, 174 mg chicory inulin (prebiotic), 19mg Microcrystalline Cellulose MCC, 4mg L-Leucine, and 3mg Silica (excipients) to be taken once daily with food
Phase 2 - PlaceboDietary supplement
Phase 2 - Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 - Standard Dose | Active comparator | 1 capsule Receives: Dietary Supplement: Three-Strain Probiotic |
| Phase 1 - High Dose | Active comparator | 2 capsules Receives: Dietary Supplement: Three-Strain Probiotic |
| Phase 2 - Active | Active comparator | Dose selected from Phase 1 Receives: Dietary Supplement: Three-Strain Probiotic |
| Phase 2 - Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Phase 2 - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events
Phase I: To evaluate the safety and tolerability of 8-week daily supplementation of high-dose versus standard dose Three-Strain Probiotic as assessed by Occurrence of any Adverse Events Change from baseline to week 8.
Measured: 8 weeks
Phase 2 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events
Phase 2: To evaluate the safety and tolerability of 8-week daily supplementation of the selected dose (from Phase I) Three-Strain Probiotic as assessed by Occurrence of any Adverse Events Change from baseline to week 8
Measured: 8 weeks
Secondary outcomes (63)
Phase 1 - Safety - Blood Biomarkers - Red Blood Cell Count
(10e12/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - White Blood Cell Count
(10e9/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Hemoglobin
(g/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Alanine Aminotransferase
(IU/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Aspartate Aminotransferase
(IU/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Serum Creatinine
(umol/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - eGFR
(mL/min/1.73 m²)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Sodium
(mmol/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Potassium
(mmol/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Total Cholesterol
(mmol/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - LDL Cholesterol
(mmol/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - HDL Cholesterol
(mmol/L)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - LDL:HDL Cholesterol Ratio
(no units)
Measured: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Fasting Glucose
(mmol/L)
Measured: 8 weeks
Phase 1 - Vital signs - Systolic Blood Pressure
mmHG
Measured: 8 weeks
Phase 1 - Vital signs - Diastolic Blood Pressure
mmHG
Measured: 8 weeks
Phase 1 - Vital signs - Heart Rate
bpm
Measured: 8 weeks
Phase 1 - Vital signs - Temperature
˚C
Measured: 8 weeks
Phase 1 - Total Food Cravings - Food Cravings Inventory (FCI-UK)
The Food Craving Inventory (FCI-UK) is a UK-specific version of the Food Craving Inventory designed to measure the frequency of cravings for specific foods over the past month. The questionnaire lists 27 food items and generates total food cravings scores.
Measured: 8 weeks
Phase 1 - Food Cravings - Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)
The Food Cravings Questionnaire- Trait- reduced (FCQ-T-r) is a 15-item reduced version of the Food Cravings Questionnaire (FCQ). Items included in the FCQ-T-r from the original version subscales include lack of control overeating (5 items), thoughts or preoccupation with food (5 items), intentions and plans to consume food (2 items), emotions before or during food craving (2 items), and cues that may trigger food craving (1 item). Participants indicate on a 6-point scale from 'never/not applicable to always' how frequently each of the 15 statements relating to food cravings is true for them.
Measured: 8 weeks
Phase 1 - Meal Tolerance Test - Plasma GLP-1 (Total)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in pg/ml.
Measured: 8 weeks
Phase 1 - Meal Tolerance Test - Plasma Glucose
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in mmol/L.
Measured: 8 weeks
Phase 1 - Meal Tolerance Test - Satiety (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 1 - Meal Tolerance Test - Hunger (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 1 - Meal Tolerance Test - Fullness (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 1 - Meal Tolerance Test - Desire to eat (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 1 - Weight
kg
Measured: 8 weeks
Phase 1 - BMI
kg/m2
Measured: 8 weeks
Phase 2 - Vital signs - Systolic Blood Pressure
mmHG
Measured: 8 weeks
Phase 2 - Vital signs - Diastolic Blood Pressure
mmHG
Measured: 8 weeks
Phase 2 - Vital signs - Heart Rate
bpm
Measured: 8 weeks
Phase 2 - Vital signs - Temperature
˚C
Measured: 8 weeks
Phase 2 - Total Food Cravings - Food Cravings Inventory (FCI-UK)
The Food Craving Inventory (FCI-UK) is a UK-specific version of the Food Craving Inventory designed to measure the frequency of cravings for specific foods over the past month. The questionnaire lists 27 food items and generates total food cravings scores.
Measured: 8 weeks
Phase 2 - Food Cravings - Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)
The Food Cravings Questionnaire- Trait- reduced (FCQ-T-r) is a 15-item reduced version of the Food Cravings Questionnaire (FCQ). Items included in the FCQ-T-r from the original version subscales include lack of control overeating (5 items), thoughts or preoccupation with food (5 items), intentions and plans to consume food (2 items), emotions before or during food craving (2 items), and cues that may trigger food craving (1 item). Participants indicate on a 6-point scale from 'never/not applicable to always' how frequently each of the 15 statements relating to food cravings is true for them.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma GLP-1 (Total)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in pg/ml.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma Glucose
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in mmol/L
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma GLP-2
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in pg/ml.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Peptide YY
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in pg/ml.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma Insulin
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. Measured in pg/ml.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Satiety (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Hunger (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Fullness (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 2 - Meal Tolerance Test - Desire to eat (VAS)
Meal Tolerance Test - initiated in the fasting state with samples collected at T0 (fasting), T30, T60, T90, T120 \& T180 mins following a standardised meal. VAS scales follow 0-100 measurement.
Measured: 8 weeks
Phase 2 - Weight
kg
Measured: 8 weeks
Phase 2 - BMI
kg/m2
Measured: 8 weeks
Phase 2 - Hormonal Health - Leptin
pg/ml
Measured: 8 weeks
Phase 2 - Hormonal Health - Ghrelin
pg/ml
Measured: 8 weeks
Phase 2 - Inflammation - IL-6
pg/ml
Measured: 8 weeks
Phase 2 - Inflammation - IL-17
pg/ml
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Red Blood Cell Count
(10e12/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - White Blood Cell Count
(10e9/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Hemoglobin
(g/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Alanine Aminotransferase
(IU/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Aspartate Aminotransferase
(IU/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Serum Creatinine
(umol/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - eGFR
(mL/min/1.73 m²)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Sodium
(mmol/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Potassium
(mmol/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Total Cholesterol
(mmol/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - LDL Cholesterol
(mmol/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - HDL Cholesterol
(mmol/L)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - LDL:HDL Cholesterol Ratio
(no units)
Measured: 8 weeks
Phase 2 - Safety - Blood Biomarkers - Fasting Glucose
(mmol/L)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start23 Sep 2024
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pendulum Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, APC Microbiome Ireland
- Responsible party
- Sponsor
- Investigators
- Adam Perlman, MD, MPH, Study director, Pendulum Therapeutics, IncNoel Caplice, MD, Principal investigator, APC Microbiome Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566884
- Sponsor's protocol ID
- PDL-25-01P - AFCRO-181
- Status last verified
- May 2026
- First submitted
- 1 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.
PubMed 17928588Belzer C, de Vos WM. Microbes inside--from diversity to function: the case of Akkermansia. ISME J. 2012 Aug;6(8):1449-58. doi: 10.1038/ismej.2012.6. Epub 2012 Mar 22.
PubMed 22437156Huber H, Schieren A, Holst JJ, Simon MC. Dietary impact on fasting and stimulated GLP-1 secretion in different metabolic conditions - a narrative review. Am J Clin Nutr. 2024 Mar;119(3):599-627. doi: 10.1016/j.ajcnut.2024.01.007. Epub 2024 Jan 11.
PubMed 38218319Yoon HS, Cho CH, Yun MS, Jang SJ, You HJ, Kim JH, Han D, Cha KH, Moon SH, Lee K, Kim YJ, Lee SJ, Nam TW, Ko G. Akkermansia muciniphila secretes a glucagon-like peptide-1-inducing protein that improves glucose homeostasis and ameliorates metabolic disease in mice. Nat Microbiol. 2021 May;6(5):563-573. doi: 10.1038/s41564-021-00880-5. Epub 2021 Apr 5.
PubMed 33820962Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
PubMed 32675291
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Phase Study on the Safety and Tolerance of a Novel Probiotic in Healthy Adults: Open-Label and Double-Blind, Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT07566884
- Acronym / sponsor ID
- PDL-25-01P - AFCRO-181
- Conditions
- Healthy Adults
- Keywords
- Probiotics, Akkermansia Muciniphila, Food Cravings, GLP-1, Insulin
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pendulum TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, APC Microbiome Ireland
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I \& II study evaluates the safety and tolerability of 8 weeks of daily supplementation with high-dose versus standard-dose of a novel three-strain probiotic. Safety and tolerability will be assessed by adverse events, safety blood profile, and vital signs. Secondary assessments include food cravings, gastrointestinal outcomes, sleep, quality of life, subjective ratings of hunger and satiety and associated hormone responses including plasma GLP-1, glucose, and insulin.
Detailed description
A Two-Phase Study safety and tolerance study:
Phase I: Open-Label Study Phase II: Randomised Double-Blind, Placebo-Controlled Study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1 - Standard Dose | Active comparator | Dietary Supplement: Three-Strain Probiotic1 capsule |
| Phase 1 - High Dose | Active comparator | Dietary Supplement: Three-Strain Probiotic2 capsules |
| Phase 2 - Active | Active comparator | Dietary Supplement: Three-Strain ProbioticDose selected from Phase 1 |
| Phase 2 - Placebo | Placebo comparator | Dietary Supplement: Phase 2 - Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be able to give written informed consent.
- Be between 18 and 65 years, inclusive.
- Has a BMI: Phase I ≤29.9kg/m2. Phase II ≤34.9kg/m2.
- Mean total food craving score (FCI-UK) of ≥2.5 at screening visit. (Phase I only) 5. Stable weight for the past 30 days (defined as ± 2.3kg).
- 6. Willing to consume the Study Product daily for the duration of the study.
Key exclusion criteria (17 listed)
- Participants who are pregnant or wish to become pregnant during the study or who are lactating and/or currently breastfeeding.
- Participants currently of biological childbearing potential, but not using a continuous effective method of contraception, as outlined below:
- Has food allergies or other issues with foods that would preclude intake of the Study Products.
- Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results. Excluded health conditions include: a. Gastrointestinal condition (including GI bleeding in the past 3 months) b. Major gastrointestinal surgery or explorations (cholecystectomy and appendectomy are allowed) c. Cancer (in the past 1 year) d. Active autoimmune condition e. Cardiovascular disease (in the past 3 months) 5. Current or recent use of a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include: a. Oral antibiotics or Antifungals (in the past 1 month) b. Medications impacting gut motility (in the 2 weeks prior to baseline) c. GLP-1 receptor agonists (in the past 6 months) d. Sulfonylureas (in the past 6 months) e. Proton Pump Inhibitors (in the past 1 month) f. Laxatives (in the past 1 month)
- 6. Current or recent (in the past 1 month) use of prohibited nutritional or non-nutritional supplements, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-Strain Probiotic≥ 500 million AFU of Clostridium butyricum strain WB-STR-0006, Akkermansia muciniphila strain WB-STR-0001, Bifidobacterium infantis Bi-26TM, 174 mg chicory inulin (prebiotic), 19mg Microcrystalline Cellulose MCC, 4mg L-Leucine, and 3mg Silica (excipients) to be taken once daily with food | Dietary supplement | Phase 1 - High Dose, Phase 1 - Standard Dose, Phase 2 - Active |
| Phase 2 - PlaceboPhase 2 - Matching Placebo | Dietary supplement | Phase 2 - Placebo |
Primary outcome
Phase 1 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events
Time frame: 8 weeks
Phase I: To evaluate the safety and tolerability of 8-week daily supplementation of high-dose versus standard dose Three-Strain Probiotic as assessed by Occurrence of any Adverse Events Change from baseline to week 8.
Phase 2 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events
Time frame: 8 weeks
Phase 2: To evaluate the safety and tolerability of 8-week daily supplementation of the selected dose (from Phase I) Three-Strain Probiotic as assessed by Occurrence of any Adverse Events Change from baseline to week 8
63 secondary outcomes
Phase 1 - Safety - Blood Biomarkers - Red Blood Cell Count
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - White Blood Cell Count
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Hemoglobin
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Alanine Aminotransferase
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Aspartate Aminotransferase
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Serum Creatinine
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - eGFR
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Sodium
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Potassium
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Total Cholesterol
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - LDL Cholesterol
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - HDL Cholesterol
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - LDL:HDL Cholesterol Ratio
Time frame: 8 weeks
Phase 1 - Safety - Blood Biomarkers - Fasting Glucose
Time frame: 8 weeks
Phase 1 - Vital signs - Systolic Blood Pressure
Time frame: 8 weeks
Phase 1 - Vital signs - Diastolic Blood Pressure
Time frame: 8 weeks
Phase 1 - Vital signs - Heart Rate
Time frame: 8 weeks
Phase 1 - Vital signs - Temperature
Time frame: 8 weeks
Phase 1 - Total Food Cravings - Food Cravings Inventory (FCI-UK)
Time frame: 8 weeks
Phase 1 - Food Cravings - Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)
Time frame: 8 weeks
Phase 1 - Meal Tolerance Test - Plasma GLP-1 (Total)
Time frame: 8 weeks
Phase 1 - Meal Tolerance Test - Plasma Glucose
Time frame: 8 weeks
Phase 1 - Meal Tolerance Test - Satiety (VAS)
Time frame: 8 weeks
Phase 1 - Meal Tolerance Test - Hunger (VAS)
Time frame: 8 weeks
Phase 1 - Meal Tolerance Test - Fullness (VAS)
Time frame: 8 weeks
Phase 1 - Meal Tolerance Test - Desire to eat (VAS)
Time frame: 8 weeks
Phase 1 - Weight
Time frame: 8 weeks
Phase 1 - BMI
Time frame: 8 weeks
Phase 2 - Vital signs - Systolic Blood Pressure
Time frame: 8 weeks
Phase 2 - Vital signs - Diastolic Blood Pressure
Time frame: 8 weeks
Phase 2 - Vital signs - Heart Rate
Time frame: 8 weeks
Phase 2 - Vital signs - Temperature
Time frame: 8 weeks
Phase 2 - Total Food Cravings - Food Cravings Inventory (FCI-UK)
Time frame: 8 weeks
Phase 2 - Food Cravings - Food Cravings Questionnaire-Trait-reduced (FCQ-T-r)
Time frame: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma GLP-1 (Total)
Time frame: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma Glucose
Time frame: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma GLP-2
Time frame: 8 weeks
Phase 2 - Meal Tolerance Test - Peptide YY
Time frame: 8 weeks
Phase 2 - Meal Tolerance Test - Plasma Insulin
Time frame: 8 weeks
Phase 2 - Meal Tolerance Test - Satiety (VAS)
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 17928588Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.
- Background: PubMed 22437156Belzer C, de Vos WM. Microbes inside--from diversity to function: the case of Akkermansia. ISME J. 2012 Aug;6(8):1449-58. doi: 10.1038/ismej.2012.6. Epub 2012 Mar 22.
- Background: PubMed 38218319Huber H, Schieren A, Holst JJ, Simon MC. Dietary impact on fasting and stimulated GLP-1 secretion in different metabolic conditions - a narrative review. Am J Clin Nutr. 2024 Mar;119(3):599-627. doi: 10.1016/j.ajcnut.2024.01.007. Epub 2024 Jan 11.
- Background: PubMed 33820962Yoon HS, Cho CH, Yun MS, Jang SJ, You HJ, Kim JH, Han D, Cha KH, Moon SH, Lee K, Kim YJ, Lee SJ, Nam TW, Ko G. Akkermansia muciniphila secretes a glucagon-like peptide-1-inducing protein that improves glucose homeostasis and ameliorates metabolic disease in mice. Nat Microbiol. 2021 May;6(5):563-573. doi: 10.1038/s41564-021-00880-5. Epub 2021 Apr 5.
- Background: PubMed 32675291Perraudeau F, McMurdie P, Bullard J, Cheng A, Cutcliffe C, Deo A, Eid J, Gines J, Iyer M, Justice N, Loo WT, Nemchek M, Schicklberger M, Souza M, Stoneburner B, Tyagi S, Kolterman O. Improvements to postprandial glucose control in subjects with type 2 diabetes: a multicenter, double blind, randomized placebo-controlled trial of a novel probiotic formulation. BMJ Open Diabetes Res Care. 2020 Jul;8(1):e001319. doi: 10.1136/bmjdrc-2020-001319.
- Individual participant dataSharing planned: Undecided
Related trials for Healthy Adults
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam Perlman, MD, MPH study director
Pendulum Therapeutics, Inc
Noel Caplice, MD principal investigator
APC Microbiome Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Strain Probiotic in people with Healthy Adults, run by Pendulum Therapeutics at 1 site in Ireland.
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 6 inclusion and 17 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: under way, not looking for participants, as of the sponsor's last update on 11 May 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 Ireland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Phase 1 - Safety and Tolerability - As assessed by Occurrence of Adverse of Events (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 NCT07566884, which also lists 5 linked publications.
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 11 May 2026.