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Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study (DIFTOB)

Primary Purpose

NAFLD, Fecal Microbiota, Gut Microbiota

Status
Active
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
FMT and placebo
Sponsored by
University of Eastern Finland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for NAFLD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Body mass index (BMI) ≥30 kg/m2 Age 18-75 years Signed informed consent Ability to take part in a group-based nutrition advice Adequate Finnish comprehension (since all advice and materials are in Finnish) Exclusion Criteria: Unable to provide written consent Attending another trial or having on-going dietary counseling at the same time Pregnancy, breast feeding Type I diabetes Inflammatory disease Liver disease other than NAFLD Excess alcohol consumption (more than 20 g/day in females and more than 30 g/day in males, on average) Dysmotility of upper GI-tract (e.g. gastroparesis) Big hiatal hernia History of a severe (anaphylactic) food allergy Active, serious medical disease with likely life expectancy less than 5 years Severe renal insufficiency (glomerular filtration rate <30%) Procedures that have changed the anatomy of GI-tract, including obesity surgery Remarkable psychiatric disorders, dementia and other diseases or conditions that could affect to the study subject´s compliance to the study Systemic antibacterial treatments three months before the study or during the study chronic or recurrent bacterial infection for which antimicrobial medications are repeatedly used Contraindication for gastroscopy Central anesthesia needed for gastroscopy Medications for losing weight (bupropion/naltrexon, orlistat, liraglutide) Intention to obesity surgery. Eligibility is evaluated by a doctor in each research unit.

Sites / Locations

  • Helsinki University Hospital
  • University of Eastern Finland
  • Lahti Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

FMT

Placebo

Arm Description

Fecal transplantation is given 2:1 compared to placebo transplantation via gastroscopy as a fluid of 100-150ml. Similar healthy diet counseling is given to all participants in both FMT and placebo group.

Placebo is brown-colored water and given the same way than fecal transplantation fluid. All study subjects receive similar dietary advice based on healthy diet. Similar healthy diet counseling is given to all participants in both FMT and placebo group.

Outcomes

Primary Outcome Measures

A change in HOMA-IR
A change in HOMA-IR at week 12 and week 52 in both study groups and hypothetically more in those with FMT compared to those with placebo.

Secondary Outcome Measures

Full Information

First Posted
November 2, 2022
Last Updated
November 2, 2022
Sponsor
University of Eastern Finland
Collaborators
Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, University of Helsinki, Kuopio University Hospital, Kuopio Research Institute of Exercise Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05607745
Brief Title
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
Acronym
DIFTOB
Official Title
Dietary Counseling Coupled With Fecal Microbiota Transplantation in the Treatment of Obesity and Non-alcoholic Fatty Liver Disease - the DIFTOB Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Eastern Finland
Collaborators
Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, University of Helsinki, Kuopio University Hospital, Kuopio Research Institute of Exercise Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
There are several studies performed to reveal the linkage between diet, fecal microbiota, and obesity. Human fecal microbiota transplantations in this asset are still scarce. Therefore, this pilot study of FMT from lean to obese people with dietary counseling will increase the knowledge, whether FMT could play a role in the treatment of obesity and NAFLD. Our primary outcome is the changes in glucose metabolism by HOMA-IR.
Detailed Description
The prevalence of obesity is rising. In 2015 39% of adults globally, and in 2017 25% of adults in Finland were obese (BMI ≥30kg/m2). Obesity increases the incidence of type 2 diabetes (T2D) and non-alcoholic fatty liver disease (NAFLD). Obesity associates with decreased gut bacterial diversity, and low microbial gene richness. The diversity of fecal microbiota composition has been shown to alter in human NAFLD. Fecal microbiota transplantation (FMT) from lean vegan donors to those with NAFLD changed fecal microbiota composition and associated with beneficial changes in plasma metabolites in a pilot randomized controlled trial. Radiological liver imagining for NAFLD is usually performed by ultrasound. Liver elastography evaluates liver stiffness and fibrosis stage. Liver steatosis and fibrosis are known to decrease along weight loss. To our knowledge, only one small study has yet combined FMT and liver imagining in a concept of NAFLD. Diet influences the gut microbiota. In obesity, the composition of fecal microbiota is altered. Alterations in plasma metabolites derived from gut microbiota and diet have been linked to NAFLD development. The composition of gut microbiome predicts the metabolic response to different dietary interventions in obese individuals. The key food items of the Healthy Nordic Diet are vegetables, fruit, berries, whole grain products, fish, and rapeseed oil. Abdominal obesity was less abundant in those consuming the Healthy Nordic Diet. Dietary fiber has been associated with metabolically beneficial changes in fecal microbiome. High fat diet has been associated with worsening of fecal microbial composition. At this moment, the only clinically approved treatment of fecal transplantation (FMT) is recurrent Clostridioides difficile infection. FMT has been studied in asset of obesity and metabolic syndrome in rats, mice and humans. Fecal transplantation from lean donors has been shown to improve insulin sensitivity in obese subjects. Bariatric surgery has been shown to increase fecal microbiota diversity. Giving FMT from bariatric surgery undergone mice or humans lead to weight reduction in the receiver mice. There are studies that have shown no change in glucose metabolism after FMT from lean donor, but also studies with favorable effect on the recipient´s insulin sensitivity and energy expenditure. The investigators will conduct the randomized controlled one year lasting intervention of dietary advice, where 2:1 participants will be given FMT from lean donor or placebo via gastroscopy to the duodenum. The aim is to investigate the effect of FMT from healthy lean individuals in obese participants receiving dietary counseling. This study is national multicenter pilot study, where we aim to recruite 54 participants in three different study centers in Kuopio, Lahti and Helsinki.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Fecal Microbiota, Gut Microbiota, Obesity, Dietary Habits, Diet, Fecal Microbiota Transplantation, Glucose Metabolism Disorders, Nutrition, Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
National multicenter placebo-controlled randomized pilot study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
FMT is given blinded for the participant. The dieticians giving the nutritional advice are also blinded.
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FMT
Arm Type
Active Comparator
Arm Description
Fecal transplantation is given 2:1 compared to placebo transplantation via gastroscopy as a fluid of 100-150ml. Similar healthy diet counseling is given to all participants in both FMT and placebo group.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is brown-colored water and given the same way than fecal transplantation fluid. All study subjects receive similar dietary advice based on healthy diet. Similar healthy diet counseling is given to all participants in both FMT and placebo group.
Intervention Type
Other
Intervention Name(s)
FMT and placebo
Intervention Description
Similar healthy diet counseling is given to all participants in both FMT and placebo group. FMT to placebo is given in 2:1.
Primary Outcome Measure Information:
Title
A change in HOMA-IR
Description
A change in HOMA-IR at week 12 and week 52 in both study groups and hypothetically more in those with FMT compared to those with placebo.
Time Frame
at week 12 and at week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Body mass index (BMI) ≥30 kg/m2 Age 18-75 years Signed informed consent Ability to take part in a group-based nutrition advice Adequate Finnish comprehension (since all advice and materials are in Finnish) Exclusion Criteria: Unable to provide written consent Attending another trial or having on-going dietary counseling at the same time Pregnancy, breast feeding Type I diabetes Inflammatory disease Liver disease other than NAFLD Excess alcohol consumption (more than 20 g/day in females and more than 30 g/day in males, on average) Dysmotility of upper GI-tract (e.g. gastroparesis) Big hiatal hernia History of a severe (anaphylactic) food allergy Active, serious medical disease with likely life expectancy less than 5 years Severe renal insufficiency (glomerular filtration rate <30%) Procedures that have changed the anatomy of GI-tract, including obesity surgery Remarkable psychiatric disorders, dementia and other diseases or conditions that could affect to the study subject´s compliance to the study Systemic antibacterial treatments three months before the study or during the study chronic or recurrent bacterial infection for which antimicrobial medications are repeatedly used Contraindication for gastroscopy Central anesthesia needed for gastroscopy Medications for losing weight (bupropion/naltrexon, orlistat, liraglutide) Intention to obesity surgery. Eligibility is evaluated by a doctor in each research unit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milla-Maria Tauriainen, MD
Organizational Affiliation
Kuopio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Facility Name
University of Eastern Finland
City
Kuopio
Country
Finland
Facility Name
Lahti Central Hospital
City
Lahti
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
RedCap will be used across different research sites.

Learn more about this trial

Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study

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