Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity (RCTFMTOb)

January 18, 2023 updated by: University Hospital of North Norway
This is a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. We will also collect data that possibly could give a better understanding of mechanisms of this correlation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Obesity is a main threat to public health in western countries. This condition increases the risk of developing type 2 diabetes, cardiovascular diseases, physical stress disorders, dispose for cancer and contributes to increased overall morbidity and mortality. However sustained weight loss lead to the reduction of risk factors and improvement of several obesity related co-morbidities.

Currently there are mainly two established treatments for severe obesity: a conservative approach through lifestyle intervention and a surgical approach with bariatric surgery. The gut microbiota is recognized as an environmental modulator of nutritional uptake and body weight. This has led to the hypothesis that the gut microbiota could be a therapeutic target fighting obesity. Fecal microbiota transplantation (FMT) has been applied for more than 50 years, and is a established treatment for refractory recurrent infection with Clostridium Difficile (CDI). Recent scientific studies have also applied FMT as treatment for other diseases like inflammatory bowel disease, irritable bowel disease and even metabolic syndrome and the results are promising.

The sample size is determined based on data from the outpatient clinic at UNN Harstad medical department. Patients here have an average weight loss of 2,5 % with conservative treatment. This will therefore be the expected result in the control group (receiving placebo). A weight reduction of 5-10% leads to significant improvement of health and quality of life, and a weight change of this magnitude is therefore the hypothesis. The difference between the two groups is estimated to 7,5 %. With these historical results, the sample size is estimated to be 19 patients in each group. Extreme values will be eliminated; more than 3 SD out of the average in the group. In this patient group, we must also be prepared to high degree loss of follow-up near one third, which is also the experience from the clinic. We will include totally 60 patients, 30 in each group.

The investigators are planning a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. In the trial there will also be collected data that possibly could give a better understanding of mechanisms of this correlation; with insulin resistance, blood pressure, complete body scan, inflammation and biochemical parameters of hepatic steatosis, changes in the patients microbiota and the development in quality of life as secondary outcome measures.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Troms
      • Harstad, Troms, Norway, 9406
        • University Hospital of North Norway

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI > 40 or BMI > 35 kg/m2 combined with comorbidity related to obesity.

Exclusion Criteria:

  • Symptomatic cardiovascular disease, lung disease, cirrhosis or significant renal failure.
  • Patients who are pregnant or breastfeeding
  • Patients who have a confirmed malignancy or cancer
  • Patients who are immunocompromised
  • Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileoectomy
  • Established drug- or alcohol abuse or particularly unstable psychosocial circumstances.
  • History of cholecystektomy (gut microbiota composition could be affected by bile acid composition)
  • New drugs the last three months or during the follow-up period that can impact on metabolism or body weight
  • Antibiotic treatment the last three months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Intervention
Active Comparator. Transplant from Donor A or Donor B, or Donor C or Donore D, one transplant consist of 50-80g of feacal matter.
Other: Fecal microbiota transplantation
The intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.
Placebo Comparator: Placebo
Placebo. Patient will recieve an autologous fecal microbiota transplantation.
Other: Placebo: fecal microbiota transplantation
The placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in individual weight loss (kg).
Time Frame: Change from baseline body weight at 12 months post FMT

Partisipants will be measured at the outpatient clinic, medical department UNN Harstad, and weight in kilograms (kg) will be recorded. The data will be represented both as average weight change and as bar charts with >10%, with comparison between the intervention and control group.

Chi Square or Fischer exact test will be used to present responders and non-responders in the active and controll group. We will use odds ratio to present responders in the active group.
Change from baseline body weight at 12 months post FMT

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in individual weight loss (kg)
Time Frame: Change from baseline body weight at 3, 6 and 12 months after FMT

Partisipants will be measured at the outpatient clinic, medical department UNN Harstad, and weight in kilograms (kg) will be recorded. The data will be represented both as average weight change and as bar charts with >5%, >15% and >20% weight loss, with comparison between the intervention and control group at each controll point.

Chi Square or Fischer exact test will be used to present responders and non-responders in the active and controll group. We will use odds ratio to present responders in the active group.
Change from baseline body weight at 3, 6 and 12 months after FMT
Change in waist circumference (cm)
Time Frame: Change from baseline waist circumferense at 3, 6 and 12 months after FMT
Participants will be measured at the outpatient clinic, medical department UNN Harstad, and waist circumference (cm) will be recorded.
Change from baseline waist circumferense at 3, 6 and 12 months after FMT
Changes in HbA1c (mmol/mol)
Time Frame: Change from baseline HbA1c at 3, 6 and 12 months after FMT
Together with C-peptide, fasting glucose and insuline it will be used to research insuline resistance.
Change from baseline HbA1c at 3, 6 and 12 months after FMT
Changes in fasting glucose (mmol/L)
Time Frame: Change from baseline fasting glucose at 3, 6 and 12 months after FMT
Together with HbA1c, C-peptide, and insuline it will be used to research insuline resistance and calculate HOMA-IR and HOMA-B
Change from baseline fasting glucose at 3, 6 and 12 months after FMT
Changes in insuline (pmol/L)
Time Frame: Change from baseline insuline at 3, 6 and 12 months after FMT
Together with HbA1c, C-peptide, and fasting glucose it will be used to research insuline resistance and calculate HOMA-IR and HOMA-B
Change from baseline insuline at 3, 6 and 12 months after FMT
Changes in C-peptide (pmol/L)
Time Frame: Change from baseline C-peptide at 3, 6 and 12 months after FMT
Together with HbA1c, fasting glucose and insuline it will be used to research insuline resistance.
Change from baseline C-peptide at 3, 6 and 12 months after FMT
Change in blood pressure
Time Frame: Change from baseline blood pressure at 3, 6 and 12 months after FMT
Participants blood pressure (mmHg) will be measured at the outpatient clinic, medical department UNN Harstad. Blood pressure is collected as the average of the last two out of three measurements, at the end of 5 min resting period in supine position.
Change from baseline blood pressure at 3, 6 and 12 months after FMT
Change in sedimentation rate (mm/t)
Time Frame: Change from baseline sedimentation rate at 3, 6 and 12 months after FMT
We will measure sedimentation rate, and together with hs-CRP and cytokine panel we will investigate inflamation between the group recieving placebo and the group recieving active transplant.
Change from baseline sedimentation rate at 3, 6 and 12 months after FMT
Change in hs-CRP (mg/L)
Time Frame: Change from baseline hs-CRP at 3, 6 and 12 months after FMT
We will measure hs-CRP, and together with sedimentation rate and cytokine panel we will investigate inflamation between the group recieving placebo and the group recieving active transplant.
Change from baseline hs-CRP at 3, 6 and 12 months after FMT
Changes in multiplex cytokine panel (pg/mL)
Time Frame: Change from baseline cytokine panel at 3, 6 and 12 months after FMT
We will run a multiplex cytokinepanel consiting of 27 different cytokines to see if the consentration of blood cytokines changes in participants after active treatment/placebo. The cytokine panel consists of TNF-a, IFN-g, IL-1b, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12(p70), IL-13, IL-15, IL-17A, MCP-1(MCAF), IP-10, Eotaxin, MIP-1a, MIP-1b, RANTES, G-CSF, GM-CSF, Basic FGF, PDGF-BB, VEGF.
Change from baseline cytokine panel at 3, 6 and 12 months after FMT
Changes in biochemical parameters of hepatic steatosis (U/L)
Time Frame: Change from baseline biochemical parameters at 3, 6 and 12 months after FMT
Photometric analysis. We will measue AST, ALT, ALP, ɣGT and amylase to look at changes in biochemical parameters of hepatic steatosis between the group recieving placebo and the group recieving active transplant
Change from baseline biochemical parameters at 3, 6 and 12 months after FMT
Changes in lipid profile based on HDL/LDL (mmol/L) and cholesterol (mmol/L)
Time Frame: Change from baseline lipid profile at 3, 6 and 12 months afterFMT
Photometric analysis. Changes in cholesterol and HDL/LDL be used to look at changes in lipid profile between the group recieving placebo and the group recieving active transplant
Change from baseline lipid profile at 3, 6 and 12 months afterFMT
Changes in life quality measured using RAND-36 questionnaire
Time Frame: Change from baseline RAND-36 score 12 months after FMT
RAND-36- Item Short Form Health Survey. The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. By an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) we will compare change in global score. We will apply last value forward for missing values
Change from baseline RAND-36 score 12 months after FMT
Changes in psychiatric comorbidity measured by HSCL-25
Time Frame: Change from baseline HSCL-25 score 12 months after FMT
HSCL-25. Consists of 25 questions. Each answer to a question has a value of 1-4. A total score over 1,75 points to psychological issues or impaired mental health
Change from baseline HSCL-25 score 12 months after FMT
Changes in dietary intake measured by FFQ
Time Frame: Change from baseline FFQ score at 3, 6 and 12 months after FMT

FFQ Change in dietary intakes measured using Food Frequency Questionnaire at baseline and at 3, 6 and 12 months after FMT will be examined.

Energy measured as kcal, nutrition (gram) and different food groups reported as gram/day
Change from baseline FFQ score at 3, 6 and 12 months after FMT
Changes in life style measured by IPAQ
Time Frame: Change from baseline IPAQ score at 3, 6 and 12 months after FMT

IPAQ Categorical Score

Three levels (categories) of physical activity are proposed:

Category 1: Low This is the lowest level of physical activity. Those individuals who not meet criteria for categories 2 or 3 are considered low/inactive.

Category 2: Moderate

Any one of the following 3 criteria:

  • 3 or more days of vigorous activity of at least 20 minutes per day OR
  • 5 or more days of moderate-intensity activity or walking of at least 30 minutes per day OR
  • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-min/week.

Category 3: High

Any one of the following 2 criteria:

  • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/ week OR
  • 7 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 3000 MET-minutes/week
Change from baseline IPAQ score at 3, 6 and 12 months after FMT
Gut microbiota composition and function
Time Frame: Change from baseline microbiota composition at 3, 6 and 12 months after FMT
Microbiota analysis and SCFA in faeces
Change from baseline microbiota composition at 3, 6 and 12 months after FMT
Short difficult childhood questionnaire
Time Frame: At baseling
Questions of childhood trauma, four or six questions
At baseling
Childhood trauma Questionnaire (CTQ)
Time Frame: Once during the follow up period in the study
A validated questionnaire to collect self-reported data about adverse childhood experiences
Once during the follow up period in the study
Heart rate variability (HRV)
Time Frame: HRV will be measured at inclusion and 3.months post FMT
A dysbiotic gut microbiota that signals with the vagal nerve can cause an exaggerated stress response in obesity characterised by decrease in heart rate variability.
HRV will be measured at inclusion and 3.months post FMT

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Engraftment of donor microbiota at 1, 3, 6 and 12 months.
Time Frame: Inclusion, 2, 3, 6 and 12 months after FMT
Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor microbiota parallels clinical response to active FMT.
Inclusion, 2, 3, 6 and 12 months after FMT
Eating behaviour
Time Frame: Change from baseline binge eating questionnaore score 12 months after FMT
Binge eating questionnaire
Change from baseline binge eating questionnaore score 12 months after FMT
Questionnaire about the impact of covid-19 on life style changes and eating habits
Time Frame: Once during the follow up period in the study
Participants which had undergone intervention and were in the follow up period, had all their appointments at the obesity clinic at UNN Harstad canceled, due to the covid-19 outbreak in the period march-20 to juli-20. This might have impacted their weight loss motivation and life style changes. We therefore asked them five questions, which we hope will shed light on the challenges they might encountered during the period of restrictions implemented by the Norwegian government.
Once during the follow up period in the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital of North Norway

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Oslo
Norwegian University of Science and Technology
University of Tromso
Nordlandssykehuset HF
Lovisenberg Diakonale Hospital
Norwegian University of Life Sciences
Helse Nord

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Per C Valle, PhD, University Hospital of North of Norway
  • Study Chair: Maria S Fjellstad, cand.med, University Hospital of North of Norway
  • Study Chair: Hege M Hanssen, M.Sc, University Hospital of North Norway

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017/1655

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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