Irritable Bowel SyndromePhase 2ACALMINCT07039747
Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome
A Phase 2 study testing treatment with DIELEN® Protect in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 1 site in France.
Trial summary
Irritable bowel syndrome (IBS) affects around 5% of the general population and remains a daily problem in clinicians' practices, with inconsistent efficacy of treatments despite patients' high expectations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- treatment with DIELEN® Protect
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Apr 2025to Feb 2027
- Phase
- Phase 2
- 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
- Irritable bowel syndrome according to Rome IV criteria
- Aged between 18 and 75 years
- IBS-SSS > 175 at inclusion
- For women of childbearing age, use of effective contraception (progestins or oestroprogestins or intrauterine device or tubal ligation) for 1 month unless postmenopausal (amenorrhoea of at least 12 months or biologically confirmed diagnosis) or woman who has had a hysterectomy or salpingectomy.
- Irritable bowel syndrome treatments that have been stable for more than one month
- Membership of a social security scheme
- Patient has read and understood the information letter and signed the consent form
Who cannot join
- Taking probiotics, food supplements containing glutamine, anti-inflammatory drugs or antibiotics in the month preceding the study.
- Allergy to fish and glutamine
- Known renal insufficiency (Glomerular Filtration Rate (GFR)<30mL/min/1.73m2), known hepatic insufficiency (Prothrombin Time (PT)<70%) or known cardiac disease.
- History of organic digestive disease (coeliac disease, inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy)
- Pregnant women, women in labour or breastfeeding mothers
- Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub-guardianship or guardianship
- Patient taking part in another trial / having taken part in another trial within a 4-week period
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, 1 recruiting
- Recruiting
CHU de Rouen
Rouen, France
Pr MELCHIOR, 00332 32 88 89 90, Chloe.Melchior@chu-rouen.fr
About this study
Irritable bowel syndrome (IBS) affects around 5% of the general population and remains a daily problem in clinicians' practices, with inconsistent efficacy of treatments despite patients' high expectations. Intestinal hyperpermeability and visceral hypersensitivity are the two major components of IBS, and both can disrupt gastrointestinal function and ultimately impair patients' quality of life.
Glutamine is a non-essential amino acid that regulates numerous metabolic pathways and plays a key role in the intestine as it is the preferred substrate for enterocytes and immune cells. A decrease in intestinal glutamine synthetase has been found in IBS, suggesting its involvement in the intestinal permeability and visceral hypersensitivity observed in patients. Ex vivo, glutamine is capable of restoring the expression of tight junction proteins in IBS-D patients. Furthermore, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a sub-group of patients with intestinal permeability disorders (post-infectious IBS-D).
Read more
The marine peptides Gabolysat® produced by the Dielen Laboratory have demonstrated their efficacy on intestinal permeability and inflammation in a preclinical model of IBS (Langlois et al. 2023), similar to glutamine supplementation in these animals. The Dielen® Protect product formulated on the basis of the results of this study combines glutamine and Gabolysat® to provide a comfort solution for IBS patients.
Our working hypothesis is that patients suffering from moderate or severe IBS could benefit from oral supplementation with DIELEN Protect to improve the symptoms associated with IBS.
100 patients with IBS (according to Rome IV criteria) will be included in our study.
All patients will test the treatment for 8 weeks (dielen protect or placebo). The efficacy will be compared between the 2 groups before and after the treatments using validated questionnaires. Therefore, all participants will fill questionnaire before and after 8 weeks of treatments : IBS severity (IBS-SSS), quality of life (GIQLI), Anxiety and depression (HAD), GI symptom related anxiety (VSI), stool frequency and consistancy (BSF scale). Microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- treatment with DIELEN® Protect, treatment with placebo of DIELEN® Protect
- Keywords
- glutamine
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with DIELEN® ProtectDrug
Also called Dielen
treatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day
treatment with placebo of DIELEN® ProtectDrug
Also called placebo
treatment with placebo of DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day
| Study group | Role | What they receive |
|---|---|---|
| treatment with DIELEN® Protect | Experimental | experimental group: treatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day Receives: Drug: treatment with DIELEN® Protect |
| control group | Placebo comparator | Control group: treatment with placebo (pea protein) for 8 weeks at a dose of 5 grams, 3x a day Receives: Drug: treatment with placebo of DIELEN® Protect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic efficacy of DIELEN® Protect supplementation
change in IBS severity score (IBS-SSS) measured before and after 8 weeks of DIELEN® Protect or placebo supplementation in patients The IBS-SSS is a questionnaire used to assess the severity of irritable bowel syndrome. Rated from 0 to 50, 50 is the worst case with a severe case
Measured: from enrollment up to 8 weeks
Secondary outcomes (8)
impact of DIELEN® Protect on the composition of the intestinal microbiota
variation in the composition of faecal microbiota measured before and after supplementation with DIELEN® Protect or placebo for 8 weeks.
Measured: from enrollment up to 8 weeks
Impact of DIELEN® Protect on quality of life
change in GIQLI score measured before and after 8 weeks' supplementation with DIELEN® Protect or placebo GILQLI : self-administered questionnaire completed by the patient, comprising 36 questions relating to digestive symptoms, their social and emotional impact, and general condition over the last few days. The answer to each question is scored from 0 (permanent symptoms) to 4 (no symptoms). The individual score is calculated by adding up all the points obtained for all the items. The overall score varies from 0 (worst possible quality of life) to 144 (best possible quality of life).
Measured: from enrollment up to 8 weeks
impact of DIELEN® Protect on gastrointestinal related anxiety
change in VSI score measured before and after DIELEN® Protect or placebo supplementation for 8 weeks
VSI : 'gastrointestinal related anxiety' scale. This scale is based on 15 questions, all with answers ranging from 0 to 5. At the end of the questionnaire, a score out of 75 is obtained. Scores close to 0 indicate no gastrointestinal anxiety, while scores close to 75 indicate severe gastrointestinal anxiety.
Measured: from enrollment up yto 8 weeks
impact of DIELEN® Protect on anxiety and/or depression
variation in HAD score measured before and after 8 weeks' supplementation with DIELEN® Protect or placebo
The HAD scale detects the presence of anxiety or depression. Each symptom is scored on 21 points. A score below 8 eliminates anxiety or depression, a score between 8 and 10 defines a doubtful state of anxiety or depression, and a score above 10 a definite state of anxiety or depression.
Measured: from enrollment up to 8 weeks
impact of DIELEN® Protect on stool frequency
variation in the mean number of stools per day before and after 8 weeks' supplementation with DIELEN® Protect or placebo (stool calendar)
Measured: from enrollment up to 8 weeks
impact of DIELEN® Protect on stool consistency
variation in the Bristol stool form before and after 8 weeks' supplementation with DIELEN® Protect or placebo
the Bristol stool form (Score de Bristol) class stools in 7 types from type 1 = constipation to type 7 = diarrhoea
Measured: from enrollment up to 8 weeks
treatment compliance rate
Compliance will be assessed by measuring the number of sachets of DIELEN® Protect or placebo not taken after 8 weeks of treatment. The patient will be considered non-compliant if the uptake of DIELEN® Protect or placebo over the 8 weeks is < 70%.
Measured: from enrollment up tu 8 weeks
Number and severity of adverse reactions
Tolerance will be assessed by the number and severity of adverse reactions at the end of treatment.
Measured: from enrollment up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start22 Apr 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 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 SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire Dielen
- Responsible party
- Sponsor
- Investigators
- Chloé MELCHIOR, PUPH, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07039747
- Sponsor's protocol ID
- 2024/0178/HP
- Acronym
- ACALMI
- Status last verified
- Jun 2025
- First submitted
- 18 Jun 2025
- Last updated
- 23 Feb 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 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT07039747
- Acronym / sponsor ID
- ACALMI / 2024/0178/HP
- Conditions
- Irritable Bowel Syndrome
- Keywords
- glutamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Laboratoire Dielen
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Jun 2025 (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 5% of the general population and remains a daily problem in clinicians' practices, with inconsistent efficacy of treatments despite patients' high expectations. Intestinal hyperpermeability and visceral hypersensitivity are the two major components of IBS, and both can disrupt gastrointestinal function and ultimately impair patients' quality of life.
Glutamine is a non-essential amino acid that regulates numerous metabolic pathways and plays a key role in the intestine as it is the preferred substrate for enterocytes and immune cells. A decrease in intestinal glutamine synthetase has been found in IBS, suggesting its involvement in the intestinal permeability and visceral hypersensitivity observed in patients. Ex vivo, glutamine is capable of restoring the expression of tight junction proteins in IBS-D patients. Furthermore, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a sub-group of patients with intestinal permeability disorders (post-infectious IBS-D).
The marine peptides Gabolysat® produced by the Dielen Laboratory have demonstrated their efficacy on intestinal permeability and inflammation in a preclinical model of IBS (Langlois et al. 2023), similar to glutamine supplementation in these animals. The Dielen® Protect product formulated on the basis of the results of this study combines glutamine and Gabolysat® to provide a comfort solution for IBS patients.
Our working hypothesis is that patients suffering from moderate or severe IBS could benefit from oral supplementation with DIELEN Protect to improve the symptoms associated with IBS.
100 patients with IBS (according to Rome IV criteria) will be included in our study.
All patients will test the treatment for 8 weeks (dielen protect or placebo). The efficacy will be compared between the 2 groups before and after the treatments using validated questionnaires. Therefore, all participants will fill questionnaire before and after 8 weeks of treatments : IBS severity (IBS-SSS), quality of life (GIQLI), Anxiety and depression (HAD), GI symptom related anxiety (VSI), stool frequency and consistancy (BSF scale). Microbiota, metabolomic and short chain fatty acid will be analysed before and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment with DIELEN® Protect | Experimental | Drug: treatment with DIELEN® Protectexperimental group: treatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day |
| control group | Placebo comparator | Drug: treatment with placebo of DIELEN® ProtectControl group: treatment with placebo (pea protein) for 8 weeks at a dose of 5 grams, 3x a day |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Irritable bowel syndrome according to Rome IV criteria
- Aged between 18 and 75 years
- IBS-SSS > 175 at inclusion
- For women of childbearing age, use of effective contraception (progestins or oestroprogestins or intrauterine device or tubal ligation) for 1 month unless postmenopausal (amenorrhoea of at least 12 months or biologically confirmed diagnosis) or woman who has had a hysterectomy or salpingectomy.
- Irritable bowel syndrome treatments that have been stable for more than one month
Key exclusion criteria (7 listed)
- Taking probiotics, food supplements containing glutamine, anti-inflammatory drugs or antibiotics in the month preceding the study.
- Allergy to fish and glutamine
- Known renal insufficiency (Glomerular Filtration Rate (GFR)<30mL/min/1.73m2), known hepatic insufficiency (Prothrombin Time (PT)<70%) or known cardiac disease.
- History of organic digestive disease (coeliac disease, inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy)
- Pregnant women, women in labour or breastfeeding mothers
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 |
|---|---|---|
| treatment with DIELEN® ProtectAlso: Dielentreatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day | Drug | treatment with DIELEN® Protect |
| treatment with placebo of DIELEN® ProtectAlso: placebotreatment with placebo of DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day | Drug | control group |
Primary outcome
Symptomatic efficacy of DIELEN® Protect supplementation
Time frame: from enrollment up to 8 weeks
change in IBS severity score (IBS-SSS) measured before and after 8 weeks of DIELEN® Protect or placebo supplementation in patients The IBS-SSS is a questionnaire used to assess the severity of irritable bowel syndrome. Rated from 0 to 50, 50 is the worst case with a severe case
8 secondary outcomes
impact of DIELEN® Protect on the composition of the intestinal microbiota
Time frame: from enrollment up to 8 weeks
Impact of DIELEN® Protect on quality of life
Time frame: from enrollment up to 8 weeks
impact of DIELEN® Protect on gastrointestinal related anxiety
Time frame: from enrollment up yto 8 weeks
impact of DIELEN® Protect on anxiety and/or depression
Time frame: from enrollment up to 8 weeks
impact of DIELEN® Protect on stool frequency
Time frame: from enrollment up to 8 weeks
impact of DIELEN® Protect on stool consistency
Time frame: from enrollment up to 8 weeks
treatment compliance rate
Time frame: from enrollment up tu 8 weeks
Number and severity of adverse reactions
Time frame: from enrollment up to 8 weeks
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 23 Feb 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
Chloé MELCHIOR, PUPH 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 Phase 2 study testing treatment with DIELEN® Protect in people with Irritable Bowel Syndrome, 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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (00332 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?
Symptomatic efficacy of DIELEN® Protect supplementation (time frame: from enrollment up to 8 weeks). 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 23 Feb 2026.