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FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

Primary Purpose

Obesity, Morbid

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Fecal microbiota transplantation
Sponsored by
Joint Authority for Päijät-Häme Social and Health Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University HospitalRecruiting
  • Päijät-Häme Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Intervention arm

Placebo arm

Arm Description

Fecal transplant from a thin donor

Fecal transplant made from patients own feces

Outcomes

Primary Outcome Measures

Reduction of weight

Secondary Outcome Measures

Full Information

First Posted
December 30, 2017
Last Updated
August 14, 2019
Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
University of Helsinki, Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03391817
Brief Title
FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY
Official Title
FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
February 28, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Joint Authority for Päijät-Häme Social and Health Care
Collaborators
University of Helsinki, Helsinki University Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention arm
Arm Type
Active Comparator
Arm Description
Fecal transplant from a thin donor
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
Fecal transplant made from patients own feces
Intervention Type
Other
Intervention Name(s)
Fecal microbiota transplantation
Intervention Description
Fecal microbiota transplantation administered in gastroscopy
Primary Outcome Measure Information:
Title
Reduction of weight
Time Frame
1,5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Perttu Lahtinen, MD
Phone
+358447195256
Email
perttu.lahtinen@phhyky.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perttu Arkkila, PhD MD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Helsinki University Hospital
City
Helsinki
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perttu Lahtinen, MD
Phone
+358447195256
Email
perttu.lahtinen@phhyky.fi
Facility Name
Päijät-Häme Central Hospital
City
Lahti
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perttu Lahtinen, MD
Phone
+358447195256
Email
perttu.lahtinen@phhyky.fi

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

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