Anorexia NervosaPIANONCT02170467
Study of Intestinal Permeability in Patients With Anorexia Nervosa
A study testing assessment of the intestinal permeability in people with Anorexia Nervosa, run by University Hospital, Rouen at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- assessment of the intestinal permeability
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesFrance
- Study dates
- 5 Jan 2015to 3 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 32Show fewer
- 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
Who cannot join
- 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,
Show all 22Show fewer
- 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,
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital de la Croix Rouge
Bois-Guillaume, 76233
CHU- Hôpitaux de Rouen
Rouen, 76031
About this study
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.
Read more
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.
- Conditions
- Anorexia Nervosa
- Being tested
- assessment of the intestinal permeability
- Keywords
- Intestinal permeability - Anorexia nervosa- Re feeding - auto-antibodies α-MSH
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
assessment of the intestinal permeabilityOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Assessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in controls and camparison with pateints with anorexia nervosa. Receives: 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. Receives: Other: assessment of the intestinal permeability |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of Sugar urinary excretion
intestinal permeability test - oral intake of lactulose - mannitol - sucralose
Measured: From day 1 to Day 17, assessment after a 10% weight gain under renutrition
Secondary outcomes (1)
sucralose urinary sampling
colon permeability assessement
Measured: From day 1 to Day 17, assessment after a 10% weight gain under renutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start5 Jan 2015
- Primary completion3 May 2018
- Study completion3 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastien GRIGIONI, MD, Study chair, CHU-Hôpitaux de Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170467
- Sponsor's protocol ID
- 2012/174/HP
- Acronym
- PIANO
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2014
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35810568
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Intestinal Permeability in Patients With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02170467
- Acronym / sponsor ID
- PIANO / 2012/174/HP
- Conditions
- Anorexia Nervosa
- Keywords
- Intestinal permeability - Anorexia nervosa- Re feeding - auto-antibodies α-MSH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 Jan 2015
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 3 May 2018 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: assessment of the intestinal permeabilityAssessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in controls and camparison with pateints with anorexia nervosa. |
| patients with anorexia nervosa | Experimental | Other: assessment of the intestinal permeabilityAssessment of intestinal permeability in small intestine (Lactulose/ Mannitol ratio) in patients with anorexia nervosa before and after re-feeding. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (32 listed)
- 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
Key exclusion criteria (22 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| assessment of the intestinal permeability | Other | Control, patients with anorexia nervosa |
Primary outcome
% 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
1 secondary outcome
sucralose urinary sampling
Time frame: From day 1 to Day 17, assessment after a 10% weight gain under renutrition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 35810568Grigioni 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastien GRIGIONI, MD study chair
CHU-Hôpitaux de Rouen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing assessment of the intestinal permeability in people with Anorexia Nervosa, run by University Hospital, Rouen at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% of Sugar urinary excretion (time frame: From day 1 to Day 17, assessment after a 10% weight gain under renutrition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.