Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05607745 |
| Other study ID # |
13.02.00 1448/2021 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 30, 2022 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
November 2022 |
| Source |
University of Eastern Finland |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
