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Effect of Intestinal microbiota transplantation on Satiety and energy metabolism in female patients with Anorexia Nervosa


- candidate number26441
- NTR NumberNTR6336
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-jan-2017
- Secondary IDs2016_180  METC
- Public Title Effect of Intestinal microbiota transplantation on Satiety and energy metabolism in female patients with Anorexia Nervosa
- Scientific TitleEffect of Intestinal microbiota transplantation on Satiety and energy metabolism in female patients with Anorexia Nervosa
- ACRONYMINSTANT trial
- hypothesisAnorexia nervosa (AN) is a psychiatric disease resulting in severely reduced food intake partly due to altered appetite/satiety balance resulting in very low BMI and the highest mortality rate of all mental illnesses1. Several forms of psychological therapies, with or without medication, have been tried, but have not been very successful. The pathophysiology of AN is incompletely understood, but disturbed intestinal microbiota composition might be involved. Since we have previously shown that fecal microbial transplantation (FMT) has an effect on metabolism, we aim to test this intervention in anorexia nervosa patients.
- Healt Condition(s) or Problem(s) studiedAnorexia nervosa
- Inclusion criteria- Caucasian female
- Older than 18 years
- BMI <17 kg/m2
- Stable medication use
- Meeting the DSM V criteria for anorexia nervosa, restricting type
- able to give informed consent
- Exclusion criteria- PPI and antibiotics use in last 3 months
- Smoking, XTC, amphetamine or cocaine abuse
- Alcohol abuse (>3/day)
- A concomitant severe psychiatric disorder, such as psychosis, severe depression or a personality disorder that renders them unsuitable for the trial as judged by a psychiatrist
- Participation in a research protocol involving radiation exposure in the last 2 years.
- Contraindication MRI (pregnancy, pacemaker and metals contraindicated for MRI).
- Cholecystectomy
- Expected prolonged compromised immunity (due to recent cytotoxic chemotherapy or HIV infection with a CD4 count < 240)
- Treatable underlying cause of anorexia/underweight
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 20-dec-2016
- planned closingdate31-dec-2018
- Target number of participants24
- Interventionssingle donor fecal transplantation from female donor with BMI of 25 kg/m2 (allogenic) or own (autologous)
- Primary outcomethe effect of FMT on different microbiota composition in relation to weight, appetite/satiety (fMRI/questionnaires) and Nutrient Drink Test ( incl plasma hormones)
- Secondary outcomethe effect of FMT on difference in resting energy expenditure (REE), physical activity energy expenditure (PAEE) , serotonin metabolism, body composition (Body Impedance Analysis, BIA) and Psychological questionnaires
- Timepointsbaseline ,6 and 12 weeks
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. PhD. M. Nieuwdorp
- CONTACT for SCIENTIFIC QUERIESMD. PhD. M. Nieuwdorp
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summarywe aim to identify driving (microbiota related) factors that can improve metabolic control, food intake and subsequent weight gain in anorexia nervosa patients by infusion donor feces
- Main changes (audit trail)
- RECORD9-jan-2017 - 31-mei-2017


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