Effect of F. Prausnitzii on Glycemic Control

NCT04938843 | Unknown

• 1 other identifier: META003
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

The microbiota is associated with a wide spectrum of diseases including diabetes and non-alcoholic fatty liver disease. In this study we will investigate if the bacteria F. prausnitzii, which is a part of the human gut microbiota, can improve metabolic parameters in subjects with impaired glucose control.

Conditions

Pre Diabetes; Impaired Glucose Tolerance; Non-Alcoholic Fatty Liver Disease

Keywords

Faecalibacterium prausnitzii; Desulfovibrio piger

Outcome Measures

Primary Outcomes (1)

• Glycemic control

  Change in time (%) glucose concentration range of 3.5-6.0 mmol/L measured with continuous glucose monitoring (CGM)

  From baseline to week 12

Secondary Outcomes (13)

• Fasting plasma glucose levels

  From baseline to week 12

• Hemoglobin A1c

  From baseline to week 12

• Homeostatic Model Assessment (HOMA) for Insulin Resistance (IR)

  From baseline to week 12

• Continuous glucose monitoring (CGM) mean

  From baseline to week 12

• CGM SD

  From baseline to week 12

Study Arms (2)

F. prausnitzii and D. piger

EXPERIMENTAL

1 capsule administered once daily 45 minutes before breakfast for 12 weeks

Dietary Supplement: F. prausnitzii and D. piger

Placebo

PLACEBO COMPARATOR

1 capsule administered once daily 45 minutes before breakfast for 12 weeks

Dietary Supplement: Placebo

Interventions

F. prausnitzii and D. piger DIETARY_SUPPLEMENT

Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks

F. prausnitzii and D. piger

Placebo DIETARY_SUPPLEMENT

Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent to participate in the study
• Man or woman 50-75 years of age
• Impaired glucose tolerance (IGT; capillary b-glucose 8.9-12.1 mmol/L, 120 minutes after OGTT), impaired fasting glucose (IFG; capillary b-glucose 6.1-6.9 mmol/L) or combined glucose intolerance (CGI, i.e. IFG and IGT)
• Weight stable ±5 kg for the last 3 months, BMI \>18 kg/m2
• Willingness and possibility to come to the planned study visits, use the Diary and eQuestionnaires as well as follow the study instructions
• Understand Swedish in speech and writing

You may not qualify if:

• Other reasons for liver inflammation e.g. hepatitis A, hepatitis B, hepatitis C, HIV-positive, confirmed or suspected cirrhosis, Wilsons disease, autoimmune hepatitis, hemochromatosis, alcohol related fatty liver or pancreatitis, laboratory screen AST/ALT \>2 (ULN), Bilirubin \>1 (ULN)
• Heart failure NYHA class III, cardiovascular event within 6 months, unstable angina pectoris
• Diabetes mellitus, HbA1c \>47 mmol/mol or fp-Glucose \>6.9 mmol/L on 2 occasions
• Chronic obstructive pulmonary disease and asthma treated with intermittent steroids to be under control
• Blood pressure \>170/105 mmHg
• Blood donation \>500 mL blood \<3 months before screening
• Anemia, Hb \<117 g/L females and Hb \<134 g/L males; leukopenia, LPK \<3.5x1E9/L, ongoing infection CRP \>10 mg/L
• Hyperthyroidism, T4 \>22 nmol/L or hypothyroidism, TSH \>4,2 mIU/L
• Laboratory result of clinical significance meaning that participation in the study is unsuitable according to Investigator
• Calculated glomerular filtration rate (GFR) \<60 mL/min/1.73 m2
• Cancer \<5 years since diagnosis, except for basal-cell carcinoma
• Treatment during the last 3 months with oral steroids, biological drugs, immunosuppressive drugs, e.g. cyklosporin, drugs known to cause liver damage or to be liver toxic
• Bariatric surgery
• Antibiotic treatment during the last 3 months or reoccurring antibiotic treatment \>3 times a year
• Regular or sporadic use of probiotic product (not food containing probiotics) during the last 3 months

Sponsors & Collaborators

• MetaboGen AB: lead
• Göteborg University: collaborator

Study Sites (1)

Wallenberg Laboratory, University of Gothenburg

Gothenburg, Västra Götaland County, 413 50, Sweden

RECRUITING

MeSH Terms

Conditions

Glucose Intolerance; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Hanns-Ulrich Marschall

  Wallenberg Laborotory, University of Gothenburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Maclus, PhD

CONTACT

+46 705823222; sara.malcus@metabogen.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 24, 2021
• Study Start: August 16, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: September 2, 2021

Record last verified: 2021-09

Locations

SE (1)