Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 603 for:    "Obesity, Morbid"
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Other: Fecal microbiota transplantation Other: Placebo: fecal microbiota transplantation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Intervention
Active Comparator. Transplant from either Donor A or Donor B, 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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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


  16. 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


Other Outcome Measures:
  1. Childhood experience [ Time Frame: At baseling ]
    Questions of childhood trauma.

  2. 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

  3. Eating behaviour [ Time Frame: Change from baseline binge eating questionnaore score 12 months after FMT ]
    Binge eating questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273855


Locations
Layout table for location information
Norway
University Hospital of North Norway
Harstad, Troms, Norway, 9406
Sponsors and Collaborators
University Hospital of North Norway
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
Layout table for investigator information
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

Layout table for additonal information
Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT03273855     History of Changes
Other Study ID Numbers: 2017/1655
First Posted: September 6, 2017    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms