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FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03391817
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborators:
Helsinki University
Helsinki University Central Hospital
Information provided by (Responsible Party):
Joint Authority for Päijät-Häme Social and Health Care

Brief Summary:
40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Active Comparator: Intervention arm
Fecal transplant from a thin donor
Other: Fecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy

Placebo Comparator: Placebo arm
Fecal transplant made from patients own feces
Other: Fecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy




Primary Outcome Measures :
  1. Reduction of weight [ Time Frame: 1,5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Candidates for the bariatric surgery

BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.

  • Availability of consecutive fecal samples during one year
  • Compliance to attend gastroscopy and FMT
  • 18-65 years

Exclusion Criteria:

  • Unable to provide informed consent
  • Pregnancy
  • Type I Diabetes Mellitus
  • Severe renal insufficiency, GFR<30%
  • Chronic or recurrent bacterial infection needing antimicrobial treatment
  • Large hiatal hernia

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): NCT03391817


Contacts
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Contact: Perttu Lahtinen, MD +358447195256 perttu.lahtinen@phhyky.fi

Locations
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Finland
Helsinki University Hospital Recruiting
Helsinki, Finland
Contact: Perttu Lahtinen, MD    +358447195256    perttu.lahtinen@phhyky.fi   
Päijät-Häme Central Hospital Recruiting
Lahti, Finland
Contact: Perttu Lahtinen, MD    +358447195256    perttu.lahtinen@phhyky.fi   
Sponsors and Collaborators
Joint Authority for Päijät-Häme Social and Health Care
Helsinki University
Helsinki University Central Hospital
Investigators
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Study Director: Perttu Arkkila, PhD MD Helsinki University Central Hospital

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Responsible Party: Joint Authority for Päijät-Häme Social and Health Care
ClinicalTrials.gov Identifier: NCT03391817     History of Changes
Other Study ID Numbers: FMTOBE
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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