Secondary endpoints, objectives and assessments
| Objectives | Endpoints | Assessments |
| Secondary | ||
| Weight reduction | Changes in % body weight | We will report participants who have a weight loss of ≥5%, >15% and 20%, using chi-square |
| Waist circumference | Measured in centimetres at inclusion and all follow-up visits | |
| Gut microbiota composition and function | Identify bacterial flora using metagenome sequencing16 | |
| Lipid profile will be analysed in blood samples taken 3, 6 and 12 months post FMT | Cholesterol, LDL, HDL including subgroups, triglycerides (collaboration with Nordlands Hospital in Bodø) | |
| A cytokine panel will be analysed in blood samples taken 3, 6 and 12 months post FMT | 27 different cytokines (TNF-a, IFN-g, IL-1b, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, MCP1, IP-10, eotaxin, MIP-1a, MIP-1b, RANTES, G-CSF, GM-CSF, basic FGF, PDGF-BB and VEGF) | |
| Content of short-chain fatty acid in faeces will be analysed in fecal samples taken 1, 3, 6 and 12 months post FMT | Measurement of SCFA in faeces (collaboration with Lovisenberg Diaconal Hospital, Oslo) | |
| Insulin resistance will be measured at inclusion, 3, 6 and 12 months post FMT | s-Glucose, HbA1c, C peptide, insulin and fasting glucose levels | |
| Blood pressure will be measured at inclusion, 3, 6 and 12 months post FMT | Collected as the average of the last two out of three measurements, at the end of 5 min resting period in supine position | |
| Inflammation will be evaluated using blood sample analysis | hs-CRP, erythrocyte sedimentation rate, IL-6 | |
| Biochemical parameters of hepatic steatosis will be evaluated using blood sample analysis | ASAT, ALAT, ALP, ɣGT and amylase | |
| Quality of life will be evaluated using RAND-36 questionnaire | Short-Form Health Survey Questionnaire (RAND-36): quality of life will be assessed by RAND-36, which is a validated instrument for general quality of life.18 A score of 100 is equivalent to perfect health | |
| Traumatic childhood and mental health disorder, share, correlation and relation to weight gain | Hopkins Symptoms Checklist-25: measures general psychological distress such as anxiety and depression19. A score of 1.75 or above indicated a clinically relevant level of symptoms of depression or anxiety Binge eating scale: subjective self-reporting on binge eating symptom pressure. Non-binge, less than 17; moderate binge, 18–26; severe binge, 27 and greater Short Difficult Childhood Questionnaire: measures whether the study participants have experienced difficulties in their childhood, by non-intrusive items including subjective evaluations of their childhood.20 The questionnaire has a maximal score of 20 Childhood Trauma Questionnaire: assesses a broad range of traumatic experiences in childhood. The questionnaire allows us to evaluate emotional, physical and sexual abuse, together with physical and emotional neglect.21 The questionnaire will be scored in categories of physical abuse (≥8), emotional abuse (≥8), sexual abuse (≥6), physical neglect (≥8) and emotional neglect (≥10) | |
| Heart rate variability | Heart rate variability will be measured using Firstbeat Lifestyle Assessment at inclusion and at 3-month follow-up. The measurement will be done at home by the study participants, as instructed by the study personnel. This will allow us to investigate if recovery of normal gut microbiota by treatment with FMT from a healthy donor restores the equilibrium between the sympathetic and parasympathetic nervous system responsible for the maintenance of autonomic homeostasis | |
| Patient-Reported Adverse Event Questionnaire | Questions regarding adverse events, allowing us to detect if any of the participants have any adverse reactions during the study period | |
| International Physical Activity Questionnaire | Collects data on health-related physical activity22 |
ALAT, alanine aminotransferase; ALP, alkaline phosphatase; ASAT, aspartate aminotransferase; FGF, fibroblast growth factors; FMT, fecal microbiota transplantation; G-CSF, Granulocyte-Colony Stimulating Factor; GM-CSF, Granulocyte-Macrophage Colony-Stimulating Factor; GT, gamma-glutamyltransferase; HbA1c, haemoglobin A1c; HDL, high-density lipoprotein; hs-CRP, high-sensitive C reactive protein; IFN, interferon; IL, interleukin; IP-10, interferon gamma-induced protein 10; LDL, low-density lipoprotein; MCP1, monocyte chemoattractant protein-1 ; MIP, Macrophage Inflammatory Proteins; PDGF-BB, platelet-derived growth factor - two B subunits; SCFA, short-chain fatty acid; TNF, tumuor necrosis factor; VEGF, vascular endothelial growth factor.