Study of Intestinal Permeability in Patients With Anorexia Nervosa (PIANO)

April 13, 2026 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bois-Guillaume, France, 76233
        • Hôpital de la Croix Rouge
      • Rouen, France, 76031
        • CHU- Hôpitaux de Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in controls and camparison with pateints with anorexia nervosa.
Other: assessment of the intestinal permeability
Experimental: patients with anorexia nervosa
Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in patients with anorexia nervosa before and after re-feeding.
Other: assessment of the intestinal permeability

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% 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
From day 1 to Day 17, assessment after a 10% weight gain under renutrition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sucralose urinary sampling
Time Frame: From day 1 to Day 17, assessment after a 10% weight gain under renutrition
colon permeability assessement
From day 1 to Day 17, assessment after a 10% weight gain under renutrition

Other Outcome Measures

Outcome Measure
Time Frame
Evolution of auto-antibodies level ((a-MSH) after re-feeding in patients with anorexia nervosa
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Study Chair: Sebastien GRIGIONI, MD, CHU-Hôpitaux de Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 5, 2015

Primary Completion (Actual)

May 3, 2018

Study Completion (Actual)

May 3, 2018

Study Registration Dates

First Submitted

April 3, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimated)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/174/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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