Effect of fecal transplantation on satiety and energy metabolism in female patients with anorexIa nervosa;

Completed

Conditions: Anorexia and satiety
10003018
10014067

Registration Number: NL-OMON46839

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 24

Inclusion Criteria

Recipients:
- Caucasian female
- Older than 18 years
- BMI <17 kg/m2
- Stable medication use
- Meeting the DSM V criteria for anorexia nervosa, restricting type (addendum 1). ;Donors:
- Healthy Caucasian female
- Older than 18 years
- BMI between 22-25 kg/m2

Exclusion Criteria

Recipients:
- Medication use, including PPI and antibiotics 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;Donors:
- Use of any medication including PPI and antibiotics
- Diarrhoea
- Cholecystectomy
- HIV, HAV, HBV, HCV, active CMV, active EBV, IBD
- Unsafe sex practice (questionnaire)
- Presence of fecal bacterial pathogens (salmonella, Shigella, Campylobacter, Yersinia) or parasites
- Positive C. difficile stool test

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Fecal gut microbiota composition (morning stool samples)<br /><br>- Response to food pictures. The primary outcome is the difference in BOLD<br /><br>signal, i.e. in CNS activation, in predefined regions in the CNS in response to<br /><br>viewing food pictures.<br /><br>- Satiety and Appetite, measured by visual analog scale (VAS), Satiety Labeled<br /><br>Intensity Magnitude (SLIM) scale and plasma markers for satiety and appetite<br /><br>(tryptophan, ghrelin, leptin, neuropeptide Y and orexin levels) upon Mixed Meal<br /><br>Test (MMT).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Energy metabolism, measured by resting energy expenditure (REE) and physical<br /><br>activity energy expenditure (PAEE)<br /><br>- Serotonin levels (platelet/serum serotonin and 24 hour collected urine for<br /><br>5-HIAA.<br /><br>- Dietary intake (https://mijn.voedingscentrum.nl/nl/eetmeter), weight and body<br /><br>composition (Body Impedance Analysis, BIA).<br /><br>- Psychological response: Score on the Yale-Brown-Cornell Eating Disorder Scale<br /><br>(YBC-EDS) and obsessive compulsive symptoms and/or compulsivity about feeding<br /><br>will be measured with the Yale Brown Obsessive Compulsive Scale)<br /><br>- Quality of life (Eating Disorders Quality of Life, EDQOL) and assessment of<br /><br>eating behaviour with the Eating Disorder Inventory (EDI-II) and the Eating<br /><br>Disorder Examination Questionnaire (EDE-Q) and the). </p><br>