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

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ClinicalTrials.gov Identifier: NCT03273855
Recruitment Status : Enrolling by invitation
First Posted : September 6, 2017
Last Update Posted : July 26, 2019
Sponsor:
Collaborators:
Norwegian University of Science and Technology
Lovisenberg Diakonale Hospital
Nordlandssykehuset HF
Helse Nord
University of Tromso
Norwegian University of Life Sciences
University of Oslo
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE September 6, 2017
Last Update Posted Date July 26, 2019
Estimated Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
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 waterfall presentation with blocks with >5%, >10%, >15% and >20% weight loss, with comparison between the intervention and control group
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
Changes in body weight [ Time Frame: 3, 6 and 12 months ]
Weight (kg); presented both as average and as waterfall presentation in categoric groups.
Change History Complete list of historical versions of study NCT03273855 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Change in visceral fat [ Time Frame: Change from baseline visceral fat at 3, 6 and 12 months after FMT ]
    Changes in body visceral fat (cm3), evaluated with DXA (Dual-energy absorptiometry) GE Lunar Prodigy. Participants will be measured under the same conditions (fasting/non fasting, light chloting, pillow/no pillow) at every measurment point
  • 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.
  • 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.
  • 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
  • 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
  • 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 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 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 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2017)
  • Body composition [ Time Frame: 3, 6 and 12 months ]
    Changes in body composition with data from bioelectrical impedance analysis (%)
  • Waist circumference [ Time Frame: 3, 6 and 12 months ]
    Changes in waist circumference (cm)
  • Insulin resistance [ Time Frame: 6 and 12 months ]
    HbA1c, C-peptide and fasting glucose level, calculating HOMA-IR and HOMA-B
  • Blood pressure [ Time Frame: 6 and 12 months ]
    Changes in blood pressure (mmHg)
  • Changes in inflammation parameters [ Time Frame: 6 and 12 months ]
    Inflammation parameters: hs-CRP, erythrocyte sedimentation rate (ESR), IL-6
  • Biochemical parameters of hepatic steatosis [ Time Frame: 6 and 12 months ]
    Liver parameters: AST, ALT, ALP, ɣGT and amylase
  • Changes in lipid profile [ Time Frame: 6 and 12 months ]
    Lipid profile: cholesterol, LDL, HDL including subgroups, triglycerides
  • Subjective appetite feelings (hunger, fullness, desire to eat and prospective food consumption) [ Time Frame: 6 months ]
    Questionnaire
  • Plasma levels of appetite related hormones (ghrelin, CCK, PYY and GLP-1) [ Time Frame: 6 months ]
    Only done in a randomized sample of ten patients. Ghrelin, CCK, GLP-1, PYY in fasting and every 30 minutes after a standard meal for 2.5h
  • Gut microbiota composition and function [ Time Frame: 6 and 12 months ]
    Simplified microbiota analysis and SCFA in feces
  • Quality of life [ Time Frame: 6 and 12 months ]
    EQ-5D
Current Other Pre-specified Outcome Measures
 (submitted: June 20, 2019)
  • Childhood experience [ Time Frame: At baseling ]
    Questions of childhood trauma.
  • Gut microbiota composition and function [ Time Frame: Change from baseline microbiota composition at 3, 6 and 12 months after FMT ]
    Simplified microbiota analysis and SCFA in faeces
  • Eating behaviour [ Time Frame: Change from baseline binge eating questionnaore score 12 months after FMT ]
    Binge eating questionnaire
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity
Official Title  ICMJE Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blinded
Primary Purpose: Treatment
Condition  ICMJE Obesity, Morbid
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Intervention
    Active Comparator. Transplant from either Donor A or Donor B, one transplant consist of 50-80g of feacal matter.
    Intervention: Other: Fecal microbiota transplantation
  • Placebo Comparator: Placebo
    Placebo. Patient will recieve an autologous fecal microbiota transplantation.
    Intervention: Other: Placebo: fecal microbiota transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: September 4, 2017)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 69 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03273855
Other Study ID Numbers  ICMJE 2017/1655
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE
  • Norwegian University of Science and Technology
  • Lovisenberg Diakonale Hospital
  • Nordlandssykehuset HF
  • Helse Nord
  • University of Tromso
  • Norwegian University of Life Sciences
  • University of Oslo
Investigators  ICMJE
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
PRS Account University Hospital of North Norway
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP