No registrations found.
ID
Source
Brief title
Health condition
anorexia nervosa
Sponsors and support
Intervention
Outcome measures
Primary outcome
the effect of FMT on different microbiota composition in relation to weight, appetite/satiety (fMRI/questionnaires) and Nutrient Drink Test ( incl plasma hormones)
Secondary outcome
the 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
Background summary
we 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
Study objective
Anorexia 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.
Study design
baseline ,6 and 12 weeks
Intervention
single donor fecal transplantation from female donor with BMI of 25 kg/m2 (allogenic) or own (autologous)
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
MEIBERGDREEF 9, KAMER F4.159.2
M. Nieuwdorp
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666612
m.nieuwdorp@amc.uva.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6181 |
| NTR-old | NTR6336 |
| Other | METC : 2016_180 |