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Patients with diarrhea-predominant irritable bowel syndrome (IBS) and functional dyspepsia (FD) were examined and received treatment in the study. Severity of complaints and quality of life patients were assessed according to questionnaires. The state of the intestinal barrier (analysis of the protein composition, intestinal mucin levels in biopsies, serum zonulin level in blood), the composition of the gut microbiota (16S rRNA gene sequencing), bacterial metabolic function (short-chain fatty acid levels in feces), and the presence of gut inflammation (levels of lymphocytes and eosinophils in biopsies) were assessed in the patients. Patients were divided into 3 treatment groups: trimebutin + placebo, rebamipide + placebo, trimebutin + rebamipide. The above parameters were compared in patients before and after treatment.
The study included 60 patients with an established diagnosis IBS and FD. Patients were randomized in toone of three groups. Patients in group 1 received Trimedat (trimebutine, marketing authorization number LP-005534/07 of 2007-12-28) for 2 months, patients in group 2 received Trimedat and Rebagit (rebamipide, marketing authorization number LP-001831 of 2012-09-12) for 2 months, patients in group 3 received Rebagit for 2 months. The patients were blinded to the treatment assignment. At inclusion and 1 month after the severity of complaints were assessed, 2 months after starting treatment, the severity of complaints, quality of life, state of tight junction proteins, mucin-2 expression level, serum zonulin level, histological investigation of the mucous membrane of the small and large intestine, state of the intestinal microbiota and short-chain fatty acid levels were assessed. After the end of the study, an interim analysis of the effect of the therapy on the parameters was carried out. In the case of a positive effect, a full analysis of all the aforementioned factors contributing to its development was to be performed.
In addition, all these parameters were also in the control group (15 healthy volunteers without complaints, matched for sex and age with the main group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | a group of patients who, after the examination, were prescribed therapy with trimebutine 600 mg per day for 2 months |
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| Group B | Experimental | a group of patients who, after the examination, were prescribed therapy with rebamipide 300 mg per day for 2 months |
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| Group C | Experimental | a group of patients who, after the examination, were prescribed therapy with trimebutine 600 mg per day + rebamipide 300 mg per day for 2 months |
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| Control | No Intervention | healthy volunteers |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prescribing anapproved drug, examination | Drug |
Then the patients were prescribed therapy with the approved drug trimebutin (trimedat) with placebo or trimebutine with rebamipide or rebamipide with placebo for 2 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of complaints | The severity of complaints is assessed using "7×7" (7 symptoms per 7 days) questionnaire and GSRS (Gastrointestinal Symptom Rating Scale) | change from baseline points of questionnaires at 2 months |
| Low-grade inflammation | In biopsies of the small and large intestine, numbers of eosinophils and lymphocytes in the field of view were assessed by histological examination with hematoxylin-eosin staining | change from baseline numbers of eosinophils and lymphocytes at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tight junction protein level | In biopsies of the small and large intestine, tight junction proteins levels are assessed by two-dimensional electrophoresis | change from baseline tight junction proteins levels at 2 months |
| Mucin-2 expression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Ivashkin | I.M. Sechenov First Moscow State Medical University (Sechenov University) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elena Poluektova | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34115808 | Result | Ivashkin V, Poluektov Y, Kogan E, Shifrin O, Sheptulin A, Kovaleva A, Kurbatova A, Krasnov G, Poluektova E. Disruption of the pro-inflammatory, anti-inflammatory cytokines and tight junction proteins expression, associated with changes of the composition of the gut microbiota in patients with irritable bowel syndrome. PLoS One. 2021 Jun 11;16(6):e0252930. doi: 10.1371/journal.pone.0252930. eCollection 2021. |
| Label | URL |
|---|---|
| Kovaleva A.L., Poluektova E.A., Shifrin O.S. Intestinal Barrier, Permeability and Nonspecific Inflammation in Functional Gastrointestinal Disorders. Russian Journal of Gastroenterology, Hepatology, Coloproctology. 2020;30(4):52-59. (In Russ.) | View source |
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Data disclosure is not permitted by the local ethics committee. For more information about the study, please contact the principal investigator.
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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The level of Mucin-2 expression in biopsies of the small and large intestine is assessed by immunohistochemistry
| change from baseline level of Mucin-2 at 2 months |
| Serum zonulin | The level of the permeability marker, serum zonulin, is assessed by enzyme-linked immunosorbent assay using an ELISA test kit (Immundiagnostik AG, Bensheim, Germany) | change from baseline level of serum zonulin at 2 months |
| Gut microbiome | The composition of the gut microbiota in feces is analyzed by 16S rRNA sequencing | change from baseline composition of the gut microbiota in feces at 2 months |
| Short-chain fatty acids | Short-chain fatty acid levels in feces are assessed by gas chromatography-mass spectrometry | change from baseline short-chain fatty acid levels at 2 months |
| Adverse events | Patients are notified of the need to report any adverse and unintended signs (any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product) | 2 months after the start of the study |
| Quality of life (general health, limitation of activities, physical health problems, emotional health problems, social activities, pain, energy and emotions, social activities, general health) | Quality of life ((general health, limitation of activities, physical health problems, emotional health problems, social activities, pain, energy and emotions, social activities, general health) was assessed using the 36-Item Short Form Survey (SF-36) questionnaire | change from baseline points of questionnaire levels at 2 months |
| Severity of complaints | The severity of complaints is assessed using "7×7" (7 symptoms per 7 days) questionnaire and GSRS (Gastrointestinal Symptom Rating Scale) | baseline |
| Low-grade inflammation | In biopsies of the small and large intestine, numbers of eosinophils and lymphocytes in the field of view were assessed by histological examination with hematoxylin-eosin staining | baseline |
| Tight junction protein level | In biopsies of the small and large intestine, tight junction proteins levels are assessed by two-dimensional electrophoresis | baseline |
| Mucin-2 expression | The level of Mucin-2 expression in biopsies of the small and large intestine is assessed by immunohistochemistry | baseline |
| Serum zonulin | The level of the permeability marker, serum zonulin, is assessed by enzyme-linked immunosorbent assay using an ELISA test kit (Immundiagnostik AG, Bensheim, Germany) | baseline |
| Gut microbiome | The composition of the gut microbiota in feces is analyzed by 16S rRNA sequencing | baseline |
| Short-chain fatty acids | Short-chain fatty acid levels in feces are assessed by gas chromatography-mass spectrometry | baseline |