FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-19

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Intervention arm

Fecal transplant from a thin donor

Group Type ACTIVE_COMPARATOR

Fecal microbiota transplantation

Intervention Type OTHER

Fecal microbiota transplantation administered in gastroscopy

Placebo arm

Fecal transplant made from patients own feces

Group Type PLACEBO_COMPARATOR

Fecal microbiota transplantation

Intervention Type OTHER

Fecal microbiota transplantation administered in gastroscopy

Interventions

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Fecal microbiota transplantation

Fecal microbiota transplantation administered in gastroscopy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No