Effectiveness of a Dietary Supplement in Irritable Bowel Syndrome
ConditionIrritable Bowel Syndrome
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity Hospital, Rouen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
treatment with DIELEN® Protect
Drugtreatment with DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day
treatment with placebo of DIELEN® Protect
Drugtreatment with placebo of DIELEN® Protect for 8 weeks at a dose of 5 grams, 3x a day
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: treatment with DIELEN® ProtectExperimental treatment 1 intervention
Group B: control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
from enrollment up to 8 weeksSecondary outcomes
1
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.
Time frame
from enrollment up to 8 weeks2
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).
Time frame
from enrollment up to 8 weeks3
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.
Time frame
from enrollment up yto 8 weeks4
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.
Time frame
from enrollment up to 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Rouen
Lead sponsor
Laboratoire Dielen
Collaborator
Source ClinicalTrials.gov