Irritable Bowel Syndrome (IBS)ENDOLORIINCT07337707
New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.
A study testing urine intestinal permeability test or lactulose/mannitol test, Blood test and food diary in people with Irritable Bowel Syndrome (IBS), run by University Hospital, Rouen at 1 site in France.
Trial summary
Irritable bowel syndrome (IBS) affects around 4% of the general population and remains the most common functional bowel disorder. It is defined by the Rome criteria as the presence of abdominal pain associated with transit disorders. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome (IBS)
- What is being tested?
- urine intestinal permeability test or lactulose/mannitol test, Blood test and food diary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For all groups:
- Patients with IBS defined by current Rome criteria (currently IV)
- Adult, aged 18 to 75
- Regulatory criteria :
- Membership of a social security scheme
- Adult having read and understood the information letter and signed the consent form
Show all 21Show fewer
- Woman of childbearing age with effective contraception for the duration of the study such as oestroprogestins, intrauterine device, tubal ligation, vasectomised partner or sexual abstinence (no heterosexual intercourse for 1 month and a negative urine pregnancy test at inclusion).
- Postmenopausal women: confirmatory diagnosis (non-medically induced amenorrhoea for at least 12 months prior to the inclusion visit or biologically documented)
- Women of childbearing age who have been rendered surgically infertile (e.g. hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
- For the IBS group with fructose malabsorption and visceral hypersensitivity (named group of interest, MalF-HyperSens) (1):
- 25g fructose breath test in favour of fructose malabsorption
- Rectal barostat finding visceral hypersensitivity
- For the IBS group with fructose malabsorption and without visceral hypersensitivity (known as the MalF-NormoSens group) (2):
- Fructose breath test at 25g dose in favour of fructose malabsorption
- Rectal barostat finding no visceral hypersensitivity
- For the IBS group without fructose malabsorption and visceral hypersensitivity (named NormoF-HyperSens group) (3):
- Fructose breath test at 25g dose in favour of no fructose malabsorption
- Rectal barostat finding visceral hypersensitivity
- For the IBS group without fructose malabsorption or visceral hypersensitivity (called the NormoF-NormoSens group) (4):
- Fructose breath test at a dose of 25g in favour of the absence of fructose malabsorption
- Rectal barostat finding no visceral hypersensitivity
Who cannot join
- Patient who has not undergone a fructose breath test or a barostat in our department in the last 10 years.
- Patient with organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis, digestive cancer, celiac disease)
- Systemic antibiotic use (oral, IV or IM) in the month prior to inclusion
- Regulatory criteria :
- Pregnant or parturient or breast-feeding woman or proven absence of contraception,
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship,
- Person undergoing research participating in another trial / having participated in another trial within a period of 2 weeks,
- History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or preventing him/her from giving informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mylene HERVET contact
France1 site
CHU de Rouen
Rouen
Chloe MELCHIOR, PUPH, +332 32 88 67 07, chloe.melchior@chu-rouen.fr
About this study
Irritable bowel syndrome (IBS) affects around 4% of the general population and remains the most common functional bowel disorder. It is defined by the Rome criteria as the presence of abdominal pain associated with transit disorders. The impact on quality of life and the associated costs make it a public health problem.
Visceral hypersensitivity is one of the functional markers of the disease and plays a part in the genesis of symptoms. It could therefore also be a therapeutic target to be explored. Diet and the intestinal microbiota are also part of the recognised pathophysiological mechanisms of this disease. Carbohydrates malabsorbed by the intestine are metabolised by the microbiota, which may contribute to the genesis of symptoms. Among these carbohydrates, fructose appears to be of particular interest. Its absorption capacity is limited, yet fructose consumption is increasing. Fructose malabsorption at a dose of 25 g is present in 22% of IBS patients. Fructose malabsorption is also associated with visceral hypersensitivity. However, the mechanism of this association remains unknown. In models of malabsorbed mice with visceral hypersensitivity, an increase in cholecystokinin was found in the terminal ileum and cecum, suggesting a potential role for this hormone in this model of IBS. However, the underlying mechanism remains poorly understood.
Read more
The objective is to determine if microbiota signature is specific of visceral hypersensitivity associated with fructose malabsorption in IBS patients.
60 patients with IBS will be included in the study in 4 groups:
- n=15 patients with visceral hypersensitivity and fructose malabsorption
- n=15 patients with visceral hypersensitivity and without fructose malabsorption
- n=15 patients without visceral hypersensitivity and with fructose malabsorption
- n=15 patients without visceral hypersensitivity and without fructose malabsorption
All patients will filled validated questionnaires and 4-days food diary. They will also have a urinary permeability test (lactulose/mannitol test) and collected stools samples for microbiota analysis.
- Conditions
- Irritable Bowel Syndrome (IBS)
- Being tested
- urine intestinal permeability test or lactulose/mannitol test, Blood test, food diary, stool samples, Microbiota analysis
- Keywords
- visceral hypersensitivity, fructose malabsorption, microbiota
- Medical subject headings
- Irritable Bowel Syndrome, Fructose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine intestinal permeability test or lactulose/mannitol testBiological
Patients will be required to fast for 12 hours and, after emptying their bladder, patients will be asked to drink 100 mL of water containing 10 g of lactulose and 5 g of mannitol. At the patient's inclusion visit, and before the test at the V1 follow-up visit, the patient will be given an explanation with recommendations on their food intake in the 24 hours before and 24 hours during the test (urine collection). Patients will be asked not to drink for 2 hours and not to eat for 5 hours after taking the lactulose and mannitol. An exhaustive urine collection will then be carried out at the patient's home over the 24 hours following the intake of the sugars. The 24-hour urine will be collected in a plastic 24-hour urine container suitable for hospital use. This urine collection will be brought back for visit 2 the following day. On receipt of the urine, the volume of urine will be noted and the appearance of the urine recorded and stored before analysis.
Blood testBiological
A fasting blood sample will be taken in 1 x 4ml EDTA-Aprotinin tube on the morning of the urine test (V1 follow-up visit). The tube will be centrifuged within 15 minutes at 4°C and then aliquoted into 3 x 500μL tubes which will be immediately frozen at -80°C for storage in a biocollection with a view to later measuring gastrointestinal peptides such as CCK, neurotensin and GLP-1.
food diaryOther
On the day of inclusion, all patients were given a food diary to fill in. They will have to fill it in over a period of 4 days, including 1 weekend day. They will be asked to note down all the food they eat during this period, as well as the quantities. The diary will be collected at the V1 visit and will then be analysed by a dietician, who will assess the average daily consumption of fructose in g/d (total fructose consumption, consumption of fructose in excess of glucose, dietary origin of fructose).
stool samplesOther
All patients will have their stools collected. Patients will have their stool collected at home using a collector given to them at the inclusion visit. They will have to bring back the stool within 6 hours for preparation and storage at -80°C.
Microbiota analysisOther
Stools will be used to analyse the composition of the intestinal microbiota by sequencing amplicons from the V3-V4 region of bacterial 16S rRNA.
| Study group | Role | What they receive |
|---|---|---|
| MalF-HyperSens | Experimental | Patients with IBS with fructose malabsorption and with visceral hypersensitivity Receives: Biological: urine intestinal permeability test or lactulose/mannitol test; Biological: Blood test; Other: food diary; Other: stool samples; Other: Microbiota analysis |
| MalF-NormoSens | Experimental | Patients with IBS with fructose malabsorption and without hypersensitivity Receives: Biological: urine intestinal permeability test or lactulose/mannitol test; Biological: Blood test; Other: food diary; Other: stool samples; Other: Microbiota analysis |
| NormoF-HyperSens | Experimental | Patients with IBS without fructose malabsorption and with visceral hypersensitivity Receives: Biological: urine intestinal permeability test or lactulose/mannitol test; Biological: Blood test; Other: food diary; Other: stool samples; Other: Microbiota analysis |
| NormoF-NormoSens | Experimental | Patients with IBS without fructose malabsorption and without visceral hypersensitivity Receives: Biological: urine intestinal permeability test or lactulose/mannitol test; Biological: Blood test; Other: food diary; Other: stool samples; Other: Microbiota analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
microbiota analysis
16S RNA gene sequencing
Measured: from enrollment up to 18 months
metabolites analysis
Mass spectrometry-based metabolomics
Measured: from enrollment up to 18 months
Secondary outcomes (8)
Intestinal permeability
lactulose-mannitol test
Measured: from enrollment up to 18 months
low grade inflammation
fecal calprotectin
Measured: from enrollment up to 18 months
fructose consumption
delay fructose consumption (g/D)
Measured: from enrollment up to 18 months
IBS severity
IBS-SSS
Measured: from enrollment up to 18 months
Stool consistency
Bristol stool form
Measured: from enrollment up to 18 months
anxiety
STAI
Measured: from enrollment up to 18 months
psychological distress
HAD
Measured: from enrollment up to 18 months
impact on quality of life
IBSQOL
Measured: from enrollment up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome (IBS)Studies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- ANR AAPG2023, INRAE-Micalis AMIPEM, INRAE-Micalis FINE
- Responsible party
- Sponsor
- Investigators
- MELCHIOR Pr MELCHIOR, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337707
- Sponsor's protocol ID
- 2023/0252/HP
- Acronym
- ENDOLORII
- Status last verified
- Jan 2026
- First submitted
- 2 Jul 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Microbiota-endocrine Axis in Fructose Malabsorption-caused Visceral Hypersensitivity in Irritable Bowel Syndrome.
- ClinicalTrials.gov ID
- NCT07337707
- Acronym / sponsor ID
- ENDOLORII / 2023/0252/HP
- Conditions
- Irritable Bowel Syndrome (IBS)
- Keywords
- visceral hypersensitivity, fructose malabsorption, microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- ANR AAPG2023, INRAE-Micalis AMIPEM, INRAE-Micalis FINE
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- 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.
Irritable bowel syndrome (IBS) affects around 4% of the general population and remains the most common functional bowel disorder. It is defined by the Rome criteria as the presence of abdominal pain associated with transit disorders. The impact on quality of life and the associated costs make it a public health problem.
Visceral hypersensitivity is one of the functional markers of the disease and plays a part in the genesis of symptoms. It could therefore also be a therapeutic target to be explored. Diet and the intestinal microbiota are also part of the recognised pathophysiological mechanisms of this disease. Carbohydrates malabsorbed by the intestine are metabolised by the microbiota, which may contribute to the genesis of symptoms. Among these carbohydrates, fructose appears to be of particular interest. Its absorption capacity is limited, yet fructose consumption is increasing. Fructose malabsorption at a dose of 25 g is present in 22% of IBS patients. Fructose malabsorption is also associated with visceral hypersensitivity. However, the mechanism of this association remains unknown. In models of malabsorbed mice with visceral hypersensitivity, an increase in cholecystokinin was found in the terminal ileum and cecum, suggesting a potential role for this hormone in this model of IBS. However, the underlying mechanism remains poorly understood.
The objective is to determine if microbiota signature is specific of visceral hypersensitivity associated with fructose malabsorption in IBS patients.
60 patients with IBS will be included in the study in 4 groups:
- n=15 patients with visceral hypersensitivity and fructose malabsorption
- n=15 patients with visceral hypersensitivity and without fructose malabsorption
- n=15 patients without visceral hypersensitivity and with fructose malabsorption
- n=15 patients without visceral hypersensitivity and without fructose malabsorption
All patients will filled validated questionnaires and 4-days food diary. They will also have a urinary permeability test (lactulose/mannitol test) and collected stools samples for microbiota analysis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MalF-HyperSens | Experimental | Biological: urine intestinal permeability test or lactulose/mannitol test, Biological: Blood test, Other: food diary, Other: stool samples, Other: Microbiota analysisPatients with IBS with fructose malabsorption and with visceral hypersensitivity |
| MalF-NormoSens | Experimental | Biological: urine intestinal permeability test or lactulose/mannitol test, Biological: Blood test, Other: food diary, Other: stool samples, Other: Microbiota analysisPatients with IBS with fructose malabsorption and without hypersensitivity |
| NormoF-HyperSens | Experimental | Biological: urine intestinal permeability test or lactulose/mannitol test, Biological: Blood test, Other: food diary, Other: stool samples, Other: Microbiota analysisPatients with IBS without fructose malabsorption and with visceral hypersensitivity |
| NormoF-NormoSens | Experimental | Biological: urine intestinal permeability test or lactulose/mannitol test, Biological: Blood test, Other: food diary, Other: stool samples, Other: Microbiota analysisPatients with IBS without fructose malabsorption and without visceral hypersensitivity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients with IBS defined by current Rome criteria (currently IV)
- Adult, aged 18 to 75
- Regulatory criteria :
- For the IBS group with fructose malabsorption and visceral hypersensitivity (named group of interest, MalF-HyperSens) (1):
- 25g fructose breath test in favour of fructose malabsorption
Key exclusion criteria (8 listed)
- Patient who has not undergone a fructose breath test or a barostat in our department in the last 10 years.
- Patient with organic digestive pathology (chronic inflammatory bowel disease, microscopic colitis, digestive cancer, celiac disease)
- Systemic antibiotic use (oral, IV or IM) in the month prior to inclusion
- Regulatory criteria :
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 |
|---|---|---|
| urine intestinal permeability test or lactulose/mannitol testPatients will be required to fast for 12 hours and, after emptying their bladder, patients will be asked to drink 100 mL of water containing 10 g of lactulose and 5 g of mannitol. At the patient's inclusion visit, and before the test at the V1 follow-up visit, the patient will be given an explanation with recommendations on their food intake in the 24 hours before and 24 hours during the test (urine collection). Patients will be asked not to drink for 2 hours and not to eat for 5 hours after taking the lactulose and mannitol. An exhaustive urine collection will then be carried out at the patient's home over the 24 hours following the intake of the sugars. The 24-hour urine will be collected in a plastic 24-hour urine container suitable for hospital use. This urine collection will be brought back for visit 2 the following day. On receipt of the urine, the volume of urine will be noted and the appearance of the urine recorded and stored before analysis. | Biological | MalF-HyperSens, MalF-NormoSens, NormoF-HyperSens, NormoF-NormoSens |
| Blood testA fasting blood sample will be taken in 1 x 4ml EDTA-Aprotinin tube on the morning of the urine test (V1 follow-up visit). The tube will be centrifuged within 15 minutes at 4°C and then aliquoted into 3 x 500μL tubes which will be immediately frozen at -80°C for storage in a biocollection with a view to later measuring gastrointestinal peptides such as CCK, neurotensin and GLP-1. | Biological | MalF-HyperSens, MalF-NormoSens, NormoF-HyperSens, NormoF-NormoSens |
| food diaryOn the day of inclusion, all patients were given a food diary to fill in. They will have to fill it in over a period of 4 days, including 1 weekend day. They will be asked to note down all the food they eat during this period, as well as the quantities. The diary will be collected at the V1 visit and will then be analysed by a dietician, who will assess the average daily consumption of fructose in g/d (total fructose consumption, consumption of fructose in excess of glucose, dietary origin of fructose). | Other | MalF-HyperSens, MalF-NormoSens, NormoF-HyperSens, NormoF-NormoSens |
| stool samplesAll patients will have their stools collected. Patients will have their stool collected at home using a collector given to them at the inclusion visit. They will have to bring back the stool within 6 hours for preparation and storage at -80°C. | Other | MalF-HyperSens, MalF-NormoSens, NormoF-HyperSens, NormoF-NormoSens |
| Microbiota analysisStools will be used to analyse the composition of the intestinal microbiota by sequencing amplicons from the V3-V4 region of bacterial 16S rRNA. | Other | MalF-HyperSens, MalF-NormoSens, NormoF-HyperSens, NormoF-NormoSens |
Primary outcome
microbiota analysis
Time frame: from enrollment up to 18 months
16S RNA gene sequencing
metabolites analysis
Time frame: from enrollment up to 18 months
Mass spectrometry-based metabolomics
8 secondary outcomes
Intestinal permeability
Time frame: from enrollment up to 18 months
low grade inflammation
Time frame: from enrollment up to 18 months
fructose consumption
Time frame: from enrollment up to 18 months
IBS severity
Time frame: from enrollment up to 18 months
Stool consistency
Time frame: from enrollment up to 18 months
anxiety
Time frame: from enrollment up to 18 months
psychological distress
Time frame: from enrollment up to 18 months
impact on quality of life
Time frame: from enrollment up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Mylene HERVET contact
MELCHIOR Pr MELCHIOR principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine intestinal permeability test or lactulose/mannitol test, Blood test and food diary in people with Irritable Bowel Syndrome (IBS), run by University Hospital, Rouen at 1 site 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 21 inclusion and 8 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chloé MELCHIOR, PUPH (+332 32 88 67 07, chloe.melchior@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
microbiota analysis (time frame: from enrollment up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.