Study of Intestinal Permeability in Patients With Anorexia Nervosa

Anorexia Nervosa Clinical Trial

— PIANO  

Official title:

Study of Intestinal Permeability in Patients With Anorexia Nervosa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02170467
• Other study ID #: 2012/174/HP
• Status: Completed
• Phase: N/A
• Start date: January 5, 2015
• Est. completion date: May 3, 2018

Study information

• Verified date: October 2019
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In healthy humans, the intestinal mucosa acts as an absorption organ and a defensive barrier preventing the passage of toxic substances from the intestinal lumen to the blood stream. Malnutrition and absence of exogenous luminal nutrients in the gastrointestinal tract profoundly affect small bowel morphology and physiology. Many reports have described alterations of ion and nutrient transport, mucosal atrophy and modifications in the intestinal permeability to macromolecules in cases of prolonged intestinal rest, as in severe starvation. These changes may dampen both the absorptive and the barrier functions of intestinal mucosa.

The assessment of intestinal permeability, by measuring the urinary excretion of substances that are not metabolised by human tissues and passively cross the intestinal epithelium, is a reliable and non invasive method to investigate the anatomo-functional integrity of the intestinal mucosa. Previous studies have shown an increase of permeability in malnourished humans . The increase of may also increase the risk for inappropriate passage of food antigens and other noxious substances across the mucosal barrier. To this regard, the enhanced susceptibility of malnourished subjects to systemic infections and postoperative sepsis has long been recognised.

Anorexia nervosa is a psychiatric disorder characterised by abnormal eating behaviours aiming to decrease body weight. Typically, women with anorexia nervosa restrict food ingestion up to severe starvation. These behaviours usually lead to malnutrition and a more or less prolonged absence of luminal nutrients in the gastrointestinal tract. Therefore, alterations in the integrity and functioning of intestinal mucosa are likely to occur in this condition. There is no information on intestinal permeability in patients with eating disorders. We hypothesised that, as it occurs in simple starvation and malnutrition, intestinal permeability should be increased in fasted undernourished people with anorexia nervosa and decrease after re feeding. Therefore, in the present study, we explored intestinal permeability of 23 subjects with anorexia nervosa by means of the lactulose-mannitol test and urinary sucralose excretion and compare them to 46 controls.

Moreover, auto-antibodies (α-MSH ) have been found in patients with anorexia nervosa. The origin of these auto-antibodies is still unknown , but some studies suggested a digestive origin. Moreover, modifications of intestinal flora have been described in patients with anorexia nervosa. Actually, a study of the intestinal barrier of patients with anorexia nervosa is necessary. In this study, a comparaison of intestinal permeability and autoantibodies (α-MSH) rate is proposed before and after re-feeding in patients with anorexia nervosa.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 3, 2018
• Est. primary completion date: May 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Patients with anorexia nervosa :

• female,

• living in Upper Normandy since 1 year at least,

• between 18 and 50 years of age

• with a BMI between 14 and 16 kg/m²,

• diagnosed as anorexia nervosa according to the DSM IV criteria

• hospitalised for the first time in the Nutrition Unit

• not being pregnant (effective contraception and negative pregnancy test)

• not breast-feeding,

• HIV-1 negative ,

• HIV-2 negative,

• HBV negative (hépatitis B virus),

• HCV negative (hépatitis C virus),

• Affiliated to the National Health Service,

• Giving a filled informed consent,

• Not included in other studies

Controls :

• female,

• living in Upper Normandy since 1 year at least,

• between 18 and 50 years of age,

• with a BMI between 20 and 24,9 kg/m²,

• without antecedent or current diagnosis of eating disorders (DSM IV criteria),

• without dyspepsia or irritable bowel syndrom for 6 month,

• not being pregnant (effective contraception and negative pregnancy test)

• not breast-feeding,

• HIV-1 negative ,

• HIV-2 negative,

• HBV negative (hépatitis B virus),

• HCV negative (hépatitis C virus),

• Affiliated to the National Health Service,

• Giving a filled informed consent,

• Not included in other studies

Exclusion Criteria:

Patients with anorexia nervosa :

• Adult under guardianship,

• Patient with inflammatory bowel disease and/or psychotic disorders,

• Antecedent of digestive surgery,

• Drug addiction for the last 6 month,

• Alcohol and/or other substance use disorder,

• Current immunological treatment, and/or non steroidal anti inflamatory and/or corticosteroids and/or anticoagulants and/or platelet antiaggregants

• galactosemia

• Lactulose intolerance,

• Laxatives intake in the last 3 days

• Antecedent of digestive surgery,

Controls :

• Adult under guardianship,

• Patient with inflammatory bowel disease and/or psychotic disorders,

• Antecedent of digestive surgery,

• Drug addiction for the last 6 month,

• Alcohol and/or other substance use disorder,

• Current immunological treatment, and/or non steroidal anti inflamatory and/or corticosteroids and/or anticoagulants and/or platelet antiaggregants

• galactosemia

• Lactulose intolerance,

• Laxatives intake in the last 3 days

• Antecedent of digestive surgery,

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• assessment of the intestinal permeability

Locations

Country	Name	City	State
France	Hôpital de la Croix Rouge	Bois Guillaume
France	CHU- Hôpitaux de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evolution of auto-antibodies level ((a-MSH) after re-feeding in patients with anorexia nervosa		Day 1
Primary	% of Sugar urinary excretion	intestinal permeability test - oral intake of lactulose - mannitol - sucralose	From day 1 to Day 17, assessment after a 10% weight gain under renutrition
Secondary	sucralose urinary sampling	colon permeability assessement	From day 1 to Day 17, assessment after a 10% weight gain under renutrition