NAFLDDIFTOBNCT05607745
Dietary Counseling Coupled With FMT in the Treatment of Obesity and NAFLD - the DIFTOB Study
A study of NAFLD and Fecal Microbiota, run by University of Eastern Finland at 3 sites in Finland.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Fecal Microbiota, Gut Microbiota
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 3 sitesFinland
- Study dates
- 30 Oct 2022to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
Finland3 sites
Helsinki University Hospital
Helsinki
University of Eastern Finland
Kuopio
Lahti Central Hospital
Lahti
About this study
Official title: Dietary Counseling Coupled With Fecal Microbiota Transplantation in the Treatment of Obesity and Non-alcoholic Fatty Liver Disease - the DIFTOB Study
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.
Read the 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.
- Conditions
- NAFLD, Fecal Microbiota, Gut Microbiota, Obesity, Dietary Habits, Diet
- Being tested
- FMT and placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Feeding Behavior, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMT and placeboOther
Similar healthy diet counseling is given to all participants in both FMT and placebo group. FMT to placebo is given in 2:1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: FMT and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at week 12 and at week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start30 Oct 2022
- Primary completionJun 2024 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- National multicenter placebo-controlled randomized pilot study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, University of Helsinki, Kuopio University Hospital, Kuopio Research Institute of Exercise Medicine
- Responsible party
- Principal investigator, Milla Tauriainen, University of Eastern Finland
- Investigators
- Milla-Maria Tauriainen, MD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607745
- Sponsor's protocol ID
- 13.02.00 1448/2021
- Acronym
- DIFTOB
- Status last verified
- Nov 2022
- First submitted
- 2 Nov 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: RedCap will be used across different research sites.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Counseling Coupled With Fecal Microbiota Transplantation in the Treatment of Obesity and Non-alcoholic Fatty Liver Disease - the DIFTOB Study
- ClinicalTrials.gov ID
- NCT05607745
- Acronym / sponsor ID
- DIFTOB / 13.02.00 1448/2021
- Conditions
- NAFLD, Fecal Microbiota, Gut Microbiota, Obesity, Dietary Habits, Diet
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Päijänne Tavastia Central Hospital, University of Helsinki, Kuopio University Hospital, Kuopio Research Institute of Exercise Medicine
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- National multicenter placebo-controlled randomized pilot study
| Arm | Type | Receives |
|---|---|---|
| FMT | Active comparator | Other: FMT and placeboFecal 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 | Placebo comparator | Other: FMT and placeboPlacebo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMT and placeboSimilar healthy diet counseling is given to all participants in both FMT and placebo group. FMT to placebo is given in 2:1. | Other | FMT, Placebo |
Primary outcome
A change in HOMA-IR
Time frame: at week 12 and at week 52
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: No. RedCap will be used across different research sites.
Related trials for NAFLD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Milla-Maria Tauriainen, MD principal investigator
Kuopio University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of NAFLD and Fecal Microbiota, run by University of Eastern Finland at 3 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A change in HOMA-IR (time frame: at week 12 and at week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.