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| Name | Class |
|---|---|
| University of Helsinki | OTHER |
| Helsinki University Central Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | Fecal transplant from a thin donor |
|
| Placebo arm | Placebo Comparator | Fecal transplant made from patients own feces |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal microbiota transplantation | Other | Fecal microbiota transplantation administered in gastroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of weight | 1,5 years |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Perttu Lahtinen, MD | Contact | +358447195256 | perttu.lahtinen@phhyky.fi |
| Name | Affiliation | Role |
|---|---|---|
| Perttu Arkkila, PhD MD | Helsinki University Central Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Recruiting | Helsinki | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36525272 | Derived | Lahtinen P, Juuti A, Luostarinen M, Niskanen L, Liukkonen T, Tillonen J, Kossi J, Ilvesmaki V, Viljakka M, Satokari R, Arkkila P. Effectiveness of Fecal Microbiota Transplantation for Weight Loss in Patients With Obesity Undergoing Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2247226. doi: 10.1001/jamanetworkopen.2022.47226. |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| Päijät-Häme Central Hospital | Recruiting | Lahti | Finland |
|
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |