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

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.

Conditions

• NAFLD
• Fecal Microbiota
• Gut Microbiota
• Obesity
• Dietary Habits
• Diet
• Fecal Microbiota Transplantation
• Glucose Metabolism Disorders
• Nutrition, Healthy

Interventions

OTHER

FMT and placebo

Similar healthy diet counseling is given to all participants in both FMT and placebo group. FMT to placebo is given in 2:1.

Sponsors & Collaborators

• Helsinki University Central Hospital

  collaborator OTHER

• Päijänne Tavastia Central Hospital

  collaborator OTHER

• University of Helsinki

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Kuopio Research Institute of Exercise Medicine

  collaborator OTHER

• University of Eastern Finland

  lead OTHER

Principal Investigators

• Milla-Maria Tauriainen, MD · Kuopio University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-10-30

Primary Completion

2024-06-30

Completion

2026-12-31

Countries

• Finland

Study Locations