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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46839
Enrollment
24
Registered
2018-02-21
Start date
2016-12-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorexia and satiety

Interventions

Patients will be treated with infusion allogenic (feces from femal donor with a BMI 22-25 kg/m2) microbial transplantation by duodenal tube after bowel lavage. Bowel lavage is performed by infusion
Anorexia nervosa
Gut microbiota
Satiety

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Recipients: - Caucasian female - Older than 18 years - BMI

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

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

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)