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

NCT05607745 | Active Not Recruiting

• 1 other identifier: 13.02.00 1448/2021
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  at week 12 and at week 52

Study Arms (2)

FMT

ACTIVE COMPARATOR

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.

Other: FMT and placebo

Placebo

PLACEBO COMPARATOR

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.

Other: FMT and placebo

Interventions

FMT and placebo OTHER

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

FMT; Placebo

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Eastern Finland: lead
• Helsinki University Central Hospital: collaborator
• Päijänne Tavastia Central Hospital: collaborator
• University of Helsinki: collaborator
• Kuopio University Hospital: collaborator
• Kuopio Research Institute of Exercise Medicine: collaborator

Study Sites (3)

Helsinki University Hospital

Helsinki, Finland

Location

University of Eastern Finland

Kuopio, Finland

Location

Lahti Central Hospital

Lahti, Finland

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Obesity; Feeding Behavior; Glucose Metabolism Disorders

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior, Animal; Behavior; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Milla-Maria Tauriainen, MD

  Kuopio University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: FMT is given blinded for the participant. The dieticians giving the nutritional advice are also blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, specialized doctor in gastroenterology and internal medicine

Model Details: National multicenter placebo-controlled randomized pilot study

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 7, 2022
• Study Start: October 30, 2022
• Primary Completion: June 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (3)