Safety and Tolerance of a Novel Three-Strain Probiotic in Healthy Adults

NCT07566884 | Active Not Recruiting

• 1 other identifier: PDL-25-01P - AFCRO-181
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Otherwise Healthy Adults, Aged Between 18-65 Years With Phase I BMI ≤29.9kg/m2 and Phase II BMI ≤34.9kg/m2

Keywords

Probiotics; Akkermansia Muciniphila; Food Cravings; GLP-1; Insulin

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  8 weeks

Secondary Outcomes (63)

• Phase 1 - Safety - Blood Biomarkers - Red Blood Cell Count

  8 weeks

• Phase 1 - Safety - Blood Biomarkers - White Blood Cell Count

  8 weeks

• Phase 1 - Safety - Blood Biomarkers - Hemoglobin

  8 weeks

• Phase 1 - Safety - Blood Biomarkers - Alanine Aminotransferase

  8 weeks

• Phase 1 - Safety - Blood Biomarkers - Aspartate Aminotransferase

  8 weeks

Study Arms (4)

Phase 1 - Standard Dose

ACTIVE COMPARATOR

1 capsule

Dietary Supplement: Three-Strain Probiotic

Phase 1 - High Dose

ACTIVE COMPARATOR

2 capsules

Dietary Supplement: Three-Strain Probiotic

Phase 2 - Active

ACTIVE COMPARATOR

Dose selected from Phase 1

Dietary Supplement: Three-Strain Probiotic

Phase 2 - Placebo

PLACEBO COMPARATOR

Dietary Supplement: Phase 2 - Placebo

Interventions

Three-Strain Probiotic DIETARY_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 1 - High Dose; Phase 1 - Standard Dose; Phase 2 - Active

Phase 2 - Placebo DIETARY_SUPPLEMENT

Phase 2 - Matching Placebo

Phase 2 - Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \. Willing to consume the Study Product daily for the duration of the study.

You may not qualify if:

• 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.
• 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)
• \. 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.

Sponsors & Collaborators

• Pendulum Therapeutics: lead
• APC Microbiome Ireland: collaborator
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, Ireland

Location

Related Publications (5)

• Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev. 2007 Oct;87(4):1409-39. doi: 10.1152/physrev.00034.2006.

  BACKGROUND

• Belzer 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

• Huber 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

• Yoon 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):563573. doi: 10.1038/s41564-021-00880-5. Epub 2021 Apr 5.

  BACKGROUND

• Perraudeau 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.

  BACKGROUND

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Adam Perlman, MD, MPH, FACP

  Pendulum Therapeutics, Inc

  STUDY DIRECTOR

• Noel Caplice, MD

  APC Microbiome Ireland

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: May 5, 2026
• Study Start: September 23, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

IE (1)