Effect of F. Prausnitzii on Glycemic Control

NCT ID: NCT04938843

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 176 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-16
• Study Completion Date: 2023-12-31

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.

Detailed Description

This is a randomized, double blind, placebo-controlled study. Subjects with impaired glucose control will after signing the informed consent and fulfilling the study criteria be randomized to study product or placebo. The randomization ratio between the study product (F. prausnitzii 1E8-5x1E8 CFU and D. piger) and placebo is 1:1. In total 176 subjects will be randomized in the study.

The study will start with a Run-in period i.e. all the subjects will be given placebo capsules. The subjects fulfilling the inclusion and exclusion criteria will be randomized at Visit 2 to either study product or placebo in the ration 1:1. The treatment will last for 12 weeks, from Visit 2 to Visit 6. The study is ended with a 2-week period of follow up after the final dose.

Blood samples are taken at Visits 1-4 and Visits 6-7. Feces samples are collected at Visit 2-7. One additional fecal sample will be sent by mail approximately one week after Visit 1. Glucose monitoring (CGM) will be initiated at Visit 1 and Visit 5 and followed for 10 days.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

F. prausnitzii and D. piger

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

Group Type: EXPERIMENTAL

F. prausnitzii and D. piger

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

F. prausnitzii and D. piger

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Confirmed IBD, irritable bowel syndrome (IBS), bile acid malabsorption, gastrointestinal infections during the last 3 months or any experienced problems from the gastrointestinal tract during the last month that the Investigator expect could influence the participation in the study
• Allergy to metronidazol, the adhesive glue for the CGM sensor, milk protein
• Smoking >10 cigarettes/day
• Alcohol consumption, >7 units/week females, >14 units/week males
• Use of narcotics e.g. cannabis, amphetamine (not medical use), hallucinogens, gamma-hydroxybutyric acid
• Pregnancy, breast-feeding or planned pregnancy
• Participation in other studies except IGT2

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

MetaboGen AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanns-Ulrich Marschall

Role: PRINCIPAL_INVESTIGATOR

Wallenberg Laborotory, University of Gothenburg

Locations

Wallenberg Laboratory, University of Gothenburg

Gothenburg, Västra Götaland County, Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Sara Maclus, PhD

Role: CONTACT

sara.malcus@metabogen.com

+46 705823222

Other Identifiers

META003

Identifier Type: -

Identifier Source: org_study_id