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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04047537
Other study ID # AFCRO-104
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 6, 2019
Est. completion date May 30, 2020

Study information

Verified date May 2022
Source Pendulum Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.


Description:

The medical food formulations being tested in this study contain butyrate-producing organisms plus a microbial strain that contributes to the integrity of the colonic mucin barrier. The microbes have been fully characterized, certified as Generally Recognized As Safe (GRAS) and manufactured to Good Manufacturing Practice (GMP) standards using excipients that are also GRAS qualified. Subjects will receive their randomized formulation twice a day for 12 weeks.The target population will be patients with Type 2 Diabetes who are not treated with anti-diabetic agents or are treated with metformin alone.


Recruitment information / eligibility

Status Terminated
Enrollment 41
Est. completion date May 30, 2020
Est. primary completion date April 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Be able to give written informed consent - Have type 2 diabetes treated with diet and exercise alone or in combination with metformin - If treated with metformin, must have been on a stable dose of the drug for a minimum of 3 months with a stable A1c value - If treated with diet and exercise alone, must have A1c value =6.5% - If treated with diet and exercise + metformin, must have a stable A1c between 7.0% and 8.5% for at least 3 months - BMI >25 but <45 - If female, must meet all the following criteria: 1. Not pregnant or breastfeeding 2. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control during the entire duration of the study - Must be able to communicate with the investigator, and understand and comply with protocol requirements Exclusion Criteria: - Subjects who have received an antibiotic, antifungal, antiparasitic, or antiviral treatment within 30 days prior to study entry - Subjects who plan to use antibiotic, antifungal, antiparasitic, or antiviral treatment during the study - Subjects using a proton pump inhibitor must be on a consistent dose that will be maintained throughout the study period - Present use of probiotics/nutritional supplements. (Note: The use of replacement doses of Vitamin D, calcium supplements, and a single daily multi-vitamin tablet is allowed) - Subjects who have participated in a structured weight-loss program within the past 3 months - Subjects who have changed body weight =3% within the past month - Excess alcohol consumption; with an alcoholic drink defined as 284 ml of beer, lager, stout , 100 ml of wine or 35.5 ml spirits 1. Women: More than 11 standard drinks/week 2. Men: More than 17 standard drinks/week - Subjects who have received an experimental drug within 30 days prior to study entry - Hospitalization for any reason within the 3 months prior to study entry (Same day surgery centre visits/procedures allowed) - Active GI disease - History of any surgery on the gastrointestinal tract except appendectomy and cholecystectomy - Cystic fibrosis - Significant renal Impairment defined as estimated Glomerular Filtration Rate <45 ml/min - Subjects receiving systemic corticosteroid therapy - Subjects receiving Immunosuppression therapy - Subjects with any condition that the investigator deems as a sound reason for disqualification from enrollment into the study

Study Design


Intervention

Other:
Medical Food Formulation 1
WBF-0011
Medical Food Formulation 2
WBF-0011 (0.2X concentration)
Placebo
Placebo Capsules identical to those containing Formulation 1 and 2

Locations

Country Name City State
Ireland Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park Cork

Sponsors (1)

Lead Sponsor Collaborator
Pendulum Therapeutics

Country where clinical trial is conducted

Ireland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hemoglobin A1c Change from baseline to Week 12 in each of the treatment groups as compared to placebo in A1c levels From Baseline to Week 12
Secondary 3-hour blood glucose Area Under the Curve (AUC) as measured by the Continuous Glucose Monitor (CGM) device in clinic during standardized 3-hour Meal Tolerance Test (MTT) Baseline to Weeks 2, 6, 9 and 12
Secondary 3-hour plasma glucose AUC as measured by laboratory plasma glucose measurements during standardized 3-hour Meal Tolerance Test (MTT) Baseline to Weeks 2, 6, 9 and 12
Secondary 3-hour blood glucose AUC as measured by the CGM device at home during standardized 3-hour Meal Tolerance Test (MTT) Baseline to Weeks 1, 3, 4, 5, 7, 8, 10, and 11.
Secondary 24-hour CGM Time in range (70 to 180 mg/dL)/24-hour period From Baseline to Week 12
Secondary Fasting Lipid Panel Change in fasting serum concentrations of total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides From Baseline to Week 12
Secondary Body weight Change in body weight in kilograms From Baseline to Week 12
Secondary Adverse Events Number of participants with adverse events related to therapy From Baseline to Week 12
Secondary Change from baseline in Laboratory Chemistry Values Number of Participants With Abnormal Laboratory Values Related to Therapy From Baseline to Week 12
Secondary Change from baseline in Laboratory Complete Blood count Values Number of Participants With Abnormal Laboratory Values Related to Therapy From Baseline to Week 12
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