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NCT Number: NCT02170467

Study of Intestinal Permeability in Patients With Anorexia Nervosa

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.

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Key information

Conditions

Anorexia Nervosa Feeding and Eating Disorders Mental Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Croix Rouge, Bois-Guillaume, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

assessment of the intestinal permeability

Other

Primary outcomes

  1. % of Sugar urinary excretion

    Time frame: From day 1 to Day 17, assessment after a 10% weight gain under renutrition

    intestinal permeability test - oral intake of lactulose - mannitol - sucralose

Secondary outcomes

  1. sucralose urinary sampling

    Time frame: From day 1 to Day 17, assessment after a 10% weight gain under renutrition

    colon permeability assessement

Other outcomes

  1. Evolution of auto-antibodies level ((a-MSH) after re-feeding in patients with anorexia nervosa

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: PIANO

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jun 23, 2014
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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