NCT02170467

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

January 5, 2015

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2018

Completed
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

3.3 years

First QC Date

April 3, 2014

Last Update Submit

April 13, 2026

Conditions

Anorexia Nervosa

Keywords

Intestinal permeability - Anorexia nervosa- Re feeding - auto-antibodies α-MSH

Outcome Measures

Primary Outcomes (1)

  • % 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 Outcomes (1)

  • sucralose urinary sampling

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

Other Outcomes (1)

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

    Day 1

Study Arms (2)

Control

EXPERIMENTAL

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

patients with anorexia nervosa

EXPERIMENTAL

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

Interventions

assessment of the intestinal permeabilityOTHER
Controlpatients with anorexia nervosa

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • +17 more criteria

You may not qualify if:

  • 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,
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital de la Croix Rouge

Bois-Guillaume, 76233, France

Location

CHU- Hôpitaux de Rouen

Rouen, 76031, France

Location

Related Publications (1)

  • Grigioni S, Achamrah N, Chan P, Guerin C, Bole-Feysot C, Delay J, Colange G, Quillard M, Coquard A, Bubenheim M, Jesus P, Tavolacci MP, Dechelotte P, Coeffier M. Intestinal permeability and appetite regulating peptides-reactive immunoglobulins in severely malnourished women with anorexia nervosa. Clin Nutr. 2022 Aug;41(8):1752-1758. doi: 10.1016/j.clnu.2022.06.036. Epub 2022 Jun 30.

    PMID: 35810568RESULT

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Sebastien GRIGIONI, MD

    CHU-Hôpitaux de Rouen

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

June 23, 2014

Study Start

January 5, 2015

Primary Completion

May 3, 2018

Study Completion

May 3, 2018

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

FR(2)