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

Primary Purpose

Anorexia Nervosa

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
assessment of the intestinal permeability
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anorexia Nervosa focused on measuring Intestinal permeability - Anorexia nervosa- Re feeding - auto-antibodies α-MSH

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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,

Sites / Locations

  • Hôpital de la Croix Rouge
  • CHU- Hôpitaux de Rouen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Control

patients with anorexia nervosa

Arm Description

Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in controls and camparison with pateints with anorexia nervosa.

Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in patients with anorexia nervosa before and after re-feeding.

Outcomes

Primary Outcome Measures

% of Sugar urinary excretion
intestinal permeability test - oral intake of lactulose - mannitol - sucralose

Secondary Outcome Measures

sucralose urinary sampling
colon permeability assessement

Full Information

First Posted
April 3, 2014
Last Updated
October 23, 2019
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT02170467
Brief Title
Study of Intestinal Permeability in Patients With Anorexia Nervosa
Acronym
PIANO
Official Title
Study of Intestinal Permeability in Patients With Anorexia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2015 (undefined)
Primary Completion Date
May 3, 2018 (Actual)
Study Completion Date
May 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa
Keywords
Intestinal permeability - Anorexia nervosa- Re feeding - auto-antibodies α-MSH

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in controls and camparison with pateints with anorexia nervosa.
Arm Title
patients with anorexia nervosa
Arm Type
Experimental
Arm Description
Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in patients with anorexia nervosa before and after re-feeding.
Intervention Type
Other
Intervention Name(s)
assessment of the intestinal permeability
Primary Outcome Measure Information:
Title
% of Sugar urinary excretion
Description
intestinal permeability test - oral intake of lactulose - mannitol - sucralose
Time Frame
From day 1 to Day 17, assessment after a 10% weight gain under renutrition
Secondary Outcome Measure Information:
Title
sucralose urinary sampling
Description
colon permeability assessement
Time Frame
From day 1 to Day 17, assessment after a 10% weight gain under renutrition
Other Pre-specified Outcome Measures:
Title
Evolution of auto-antibodies level ((a-MSH) after re-feeding in patients with anorexia nervosa
Time Frame
Day 1

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien GRIGIONI, MD
Organizational Affiliation
CHU-Hôpitaux de Rouen
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital de la Croix Rouge
City
Bois Guillaume
ZIP/Postal Code
76233
Country
France
Facility Name
CHU- Hôpitaux de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France

12. IPD Sharing Statement

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Study of Intestinal Permeability in Patients With Anorexia Nervosa

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