Status:
TERMINATED
Placebo-Controlled Clinical Nutrition Study of the Metabolic Effects of Food Product WBF-0011 in Type 2 Diabetes
Lead Sponsor:
Pendulum Therapeutics
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This 12 week placebo-controlled study evaluates the safety and impact of 2 different strengths of the medical food formulation WBF-0011.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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:
- Not pregnant or breastfeeding
- 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
- 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
- Women: More than 11 standard drinks/week
- 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
Key Trial Info
Start Date :
August 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04047537
Start Date
August 6 2019
End Date
May 30 2020
Last Update
May 6 2022
Active Locations (1)
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1
Atlantia Food Clinical Trials, 1st Floor, Block C, Heron House, Blackpool Retail Park
Cork, Ireland