Irritable Bowel SyndromeMISSISIIPINCT06291038
Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel Syndrome With Impaired Intestinal Permeability
A study testing • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 4 sites in France.
Trial summary
Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high. One of the functional abnormalities described during IBS is increased intestinal permeability. 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?
- • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 3 Oct 2024to 1 Mar 2029
- 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
- Adult aged 18 to 75
- Diarrheal irritable bowel syndrome (IBS-D), according to the Rome IV criteria (appendix 2)
- Francis score > 175/500 at inclusion (corresponding to moderate to severe IBS)
- Treatments for IBS stable for >1 month
- Affiliation to a social security system
- Adult person having read and understood the information letter and signed the consent form
- Woman of childbearing age having effective/very effective contraception (Cf. CTFG) (estrogen-progestins or intrauterine device or tubal ligation) for 1 month and a negative urine pregnancy test
- Postmenopausal woman: confirmatory diagnosis (amenorrhea not medically induced for at least 12 months before the inclusion visit or biologically documented)
Who cannot join
- Taking probiotics, anti-inflammatories, corticosteroids or antibiotics systemically (oral or injectable) in the month preceding the study and during the duration of the study treatment,
- Known diagnosis of active autoimmune disease (type 1 diabetes, lupus, multiple sclerosis, thyroiditis, ankylosing spondylitis, rheumatoid arthritis or psoriasis)
- Known allergy to glutamine,
- Contraindication to taking glutamine, protein powder, lactulose or mannitol (including sugar-free chewing gum),
- Use of osmotic laxatives and/or taking lactulose and/or protein supplementation (including taking glutamine) in the 4 weeks preceding the start of the study,
- Renal insufficiency (GFR<40mL/min), hepatic insufficiency (PT<70) or known heart disease,
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- ATCD of digestive disease (celiac disease, chronic inflammatory bowel disease, abdominal surgery other than appendectomy or cholecystectomy),
- Occlusive or subocclusive syndrome,
- Digestive perforation or suspicion of perforation,
- Abdominal pain syndrome of undetermined cause,
- Chronic alcohol consumption (>14 units/week),
- Pregnant or parturient or breastfeeding woman or proven absence of contraception,
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection/under guardianship or curatorship,
- Person participating in research participating in another trial / having participated in another trial within 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 them from giving informed consent.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Chu Amiens
Amiens, 80054
Céline Ledoux, 03 22 08 83 72, ledoux.celine@chu-amiens.fr
Céline Rouze, 03 22 08 83 71, rouze.celine@chu-amiens.fr
- Recruiting
CHU CAEN
Caen, 14033
Arnaud Leroux, 02-31-06-52-94, promotion-ext@chu-caen.fr
Marie-Astrid Piquet, Pr
- Recruiting
Ch Le Havre
Le Havre, 76290
Angelique Picard, 02.32.73.48.56, angelique.picard@ch-havre.fr
Caroline Lemaitre, Dr
- Recruiting
Chu Rouen
Rouen, 76031
Chloe Melchior, Dr, 02 32 88 67 07, chloe.melchior@chu-rouen.fr
Chloe Melchior, Dr
About this study
Official title: Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel
Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Read more
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.
Read the detailed description
Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks, • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.
- 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.
• Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeksDietary supplement
treatment with glutamine at a dose of 5g 3 times a day for 8 weeks
• Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.Dietary supplement
treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Glutamine | Experimental | • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks. Receives: Dietary Supplement: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks |
| Protifar | Placebo comparator | • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. Receives: Dietary Supplement: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability
the change in Francis score measured before and after glutamine or placebo supplementation for 8 weeks in patients suffering from IBS-D with increased intestinal permeability. Rated from 0 et 500, 500 is the worst case with a severe form
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start3 Oct 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric; prospective; randomized; double blind; interregional
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291038
- Sponsor's protocol ID
- 2021/0381/HP
- Acronym
- MISSISIIPI
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2024
- Last updated
- 20 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 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Glutamine Supplementation in Patients Suffering From Irritable Bowel
- ClinicalTrials.gov ID
- NCT06291038
- Acronym / sponsor ID
- MISSISIIPI / 2021/0381/HP
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 4 Mar 2024 (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 approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.
Detailed description
Irritable bowel syndrome (IBS) affects approximately 5% of the general population and remains a daily problem in the practice of clinicians with inconsistent effectiveness of treatments while patients' expectations are high.
One of the functional abnormalities described during IBS is increased intestinal permeability. This increase in intestinal permeability is primarily present in the diarrheal subtype (IBS-D) and can be measured using the lactulose/mannitol test.
Glutamine is a non-essential amino acid which regulates numerous metabolic pathways, and which plays a key role in the intestine because it is the preferential substrate of enterocytes and immune cells. Ex vivo, glutamine is able to restore the expression of tight junction proteins in patients suffering from IBS-D. On the other hand, glutamine supplementation is capable of reducing abdominal pain and restoring intestinal permeability disorders in a subgroup of patients with intestinal permeability disorder (post-infectious IBS-D).
The working hypothesis would be that all patients suffering from IBS with permeability disorder, measured by the lactulose/mannitol test, could benefit from oral glutamine supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentric; prospective; randomized; double blind; interregional
| Arm | Type | Receives |
|---|---|---|
| Glutamine | Experimental | Dietary Supplement: • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks• Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks. |
| Protifar | Placebo comparator | Dietary Supplement: • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.• Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult aged 18 to 75
- Diarrheal irritable bowel syndrome (IBS-D), according to the Rome IV criteria (appendix 2)
- Francis score > 175/500 at inclusion (corresponding to moderate to severe IBS)
- Treatments for IBS stable for >1 month
- Affiliation to a social security system
Key exclusion criteria (15 listed)
- Taking probiotics, anti-inflammatories, corticosteroids or antibiotics systemically (oral or injectable) in the month preceding the study and during the duration of the study treatment,
- Known diagnosis of active autoimmune disease (type 1 diabetes, lupus, multiple sclerosis, thyroiditis, ankylosing spondylitis, rheumatoid arthritis or psoriasis)
- Known allergy to glutamine,
- Contraindication to taking glutamine, protein powder, lactulose or mannitol (including sugar-free chewing gum),
- Use of osmotic laxatives and/or taking lactulose and/or protein supplementation (including taking glutamine) in the 4 weeks preceding the start of the study,
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 |
|---|---|---|
| • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weekstreatment with glutamine at a dose of 5g 3 times a day for 8 weeks | Dietary supplement | Glutamine |
| • Control group: treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks.treatment with a protein powder (Protifar) (Placébo) 5g 3 times a day for 8 weeks. | Dietary supplement | Protifar |
Primary outcome
Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability
Time frame: 8 weeks
the change in Francis score measured before and after glutamine or placebo supplementation for 8 weeks in patients suffering from IBS-D with increased intestinal permeability. Rated from 0 et 500, 500 is the worst case with a severe form
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 20 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing • Experimental group: treatment with glutamine at a dose of 5g 3 times a day for 8 weeks in people with Irritable Bowel Syndrome, run by University Hospital, Rouen at 4 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 8 inclusion and 15 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 20 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 4 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. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the symptomatic effectiveness of glutamine supplementation in patients suffering from IBS-D with increased intestinal permeability (time frame: 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 20 Feb 2026.