Trial schedule with data capture of patient-reported outcomes
| Screening period | Treatment period | Follow-up period | ||||
| First meeting/inclusion | Treatment day | 1 month | 3 months | 6 months | 12 months | |
| Informed consent and inclusion/exclusion evaluation | X | |||||
| Physical examination and vital signs | X* | X* | X* | X* | ||
| 15 min of continuous ECG for HRV measurement† | X‡ | X‡ | ||||
| Short Difficult Childhood Questionnaire | X | |||||
| Binge Eating Questionnaire | X | X | ||||
| RAND-36 | X | X | ||||
| HSCL-25 | X | X | ||||
| IPAQ | X | X | X | |||
| CTQ | X | |||||
| Questions about COVID-19 vaccination and infection§ | X | X | X | X | X | |
| Questions regarding the lockdown due to COVID-19¶ | X | X | X | X | X | |
| Patient-Reported Adverse Event | X | X | X | |||
| FFQ | X | X | X | X | ||
| iDXA total body | X | X | ||||
| Blood samples | X**†† | X†† | X†† | X†† | ||
| Fecal sample | X‡‡§§ | X§§ | X§§ | X§§ | X§§ | |
| Fecal microbiota transplantation | X | |||||
Data capture in the electronic case report form. Data capture on paper.
*Blood pressure, pulse, weight loss in per cent and anthropometric measurement.
†The HRV measurement will only be performed on the last 20 participants in the study.
‡Will be measured by the participant at home as instructed by the study personnel.
§Included participants, and participants still in the follow-up period, were asked questions about COVID-19 vaccination and COVID-19 infection from June 21.
¶Will only be given to participants who were in the follow-up period from March 20 to July 20.
**Haemoglobin (Hb), leucocytes, thrombocytes, folate, iron, ferritin, total iron-binding capacity, vitamin B12 and vitamin D.
††High-sensitive C reactive protein, erythrocyte sedimentation rate, Hb, hematocrit, white blood cell count, platelets, sodium, potassium, creatinine, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, low-density lipoprotein, high-density lipoprotein (including subgroups), triglycerides, thyroid-stimulating hormone, free thyroxine 4, HbA1c, C-peptide, cholesterol, amylase, fasting glucose level, insulin, quantifying the sensitivity and beta-cell function (Homeostatic Model Assessment of Insulin Resistance and Homeostatic Model Assessment of beta cell function) using calculators, cytokines, Tempus RNA for storage.
‡‡Short-chain fatty acid (SCFA), microbiota, possible placebo and storage.
§§SCFA, microbiota and storage.
CTQ, Childhood Trauma Questionnaire; FFQ, Food Frequency Questionnaire; HRV, heart rate variability; HSCL-25, Hopkins Symptoms Checklist-25; iDXA, dual-energy X-ray absorptiometry; IPAQ, International Physical Activity Questionnaire.