Effectiveness of Fecal Microbiota Transplantation for Weight Loss in Patients With Obesity Undergoing Bariatric Surgery: A Randomized Clinical Trial.

Importance: Severe obesity is a major health concern. However, a few patients remain resistant to bariatric surgery and other treatments. Animal studies suggest that weight may be altered by fecal microbiota transplantation (FMT) from a lean donor. Objective: To determine whether FMT from a lean donor reduces body weight and further improves the results of bariatric surgery. Design, Setting, and Participants: This double-blinded, placebo-controlled, multicenter, randomized clinical trial was conducted in 2018 to 2021 among adult individuals with severe obesity treated at 2 bariatric surgery centers in Finland and included 18 months of follow-up. Patients eligible for bariatric surgery were recruited for the study. Data were analyzed from March 2021 to May 2022. Interventions: FMT from a lean donor or from the patient (autologous placebo) was administered by gastroscopy into the duodenum. Bariatric surgery was performed 6 months after the baseline intervention using laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG). Main Outcomes and Measures: The main outcome was weight reduction measured as the percentage of total weight loss (TWL). Results: Forty-one patients were recruited to participate in the study and were included in the final analysis (29 women [71.1%]; mean [SD] age, 48.7 [8.7] years; mean [SD] body mass index, 42.5 [6.0]). A total of 21 patients received FMT from a lean donor, and 20 received an autologous placebo. Six months after FMT, 34 patients underwent LRYGB and 4 underwent LSG. Thirty-four patients (82.9%) attended the last visit 18 months after the baseline visit. The percentage of TWL at 6 months was 4.8% (95% CI, 2.7% to 7.0%; P < .001) in the FMT group and 4.6% (95% CI, 1.5% to 7.6%; P = .006) in the placebo group, but no difference was observed between the groups. At 18 months from the baseline (ie, 12 months after surgery), the percentage of TWL was 25.3% (95% CI, 19.5 to 31.1; P < .001) in the FMT group and 25.2% (95% CI, 20.2 to 30.3; P < .001) in the placebo group; however, no difference was observed between the groups. Conclusions and Relevance: FMT did not affect presurgical and postsurgical weight loss. Further studies are needed to elucidate the possible role of FMT in obesity. Trial Registration: ClinicalTrials.gov Identifier: NCT03391817.

Type 2 diabetes prevention in the "real world": one-year results of the GOAL Implementation Trial.

OBJECTIVE: "Real-world" implementation of lifestyle interventions is a challenge. The Good Ageing in Lahti Region (GOAL) Lifestyle Implementation Trial was designed for the primary health care setting, with lifestyle and risk reduction objectives derived from the major diabetes prevention efficacy trials. We report on the program's effectiveness as well as findings related to the program's reach, adoption, and implementation. RESEARCH DESIGN AND METHODS: A total of 352 middle-aged participants with elevated type 2 diabetes risk were recruited from the health care centers in Päijät-Häme Province in Finland. The intervention included six group counseling sessions, delivered by trained public health nurses. Measurement was conducted at baseline and 12 months. Clinical risk factors were measured by study nurses, and lifestyle outcomes were analyzed from self-reports. Lifestyle outcomes were compared with the outcomes achieved in relevant efficacy trials, and within-subject changes were tested for risk reduction. RESULTS: At baseline, mean BMI was >32 kg/m2, and 25% of the participants had impaired glucose tolerance. At 12 months, 20% of participants achieved at least four of five key lifestyle outcomes, with these results being comparable with the reference trials. However, physical activity and weight loss goals were achieved significantly less frequently (65 vs. 86% and 12 vs. 43%, respectively). Several clinical risk factors decreased, more so among men than women. CONCLUSIONS: This trial demonstrates that lifestyle counseling can be effective and is feasible in real-world settings for individuals with elevated risk of type 2 diabetes. To increase program impact, program exposure and treatment intensity need to be increased.