Irritable Bowel Syndrome and Osteopathic Manipulative Therapy (IBSOMT)
Irritable Bowel Syndrome
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring IBS, Osteopathic manipulative treatment, pain
Eligibility Criteria
Inclusion Criteria:
- Patients of both sexes ≥18 years.
- Patient suffering from IBS according to the Rome III criteria:
- IBS SSS must be ≥ 175 at inclusion. Patients who received over the past 5 years a colonoscopy.
- Physical examination without clinically relevant abnormalities during the Screening period.
- Patient is willing to be compliant with study procedures.
- Patient who signed the informed consent before carrying out any procedure related to the study.
- Mentally competent, able to give written informed consent prior to any study-related procedure and compliant to undergo all visits and procedures scheduled in the study
- Medical Insurance
Exclusion Criteria:
- Patient has had surgery that meets any of the following criteria:
- Patient has any elective major surgery planned or expected at any time during the study.
- Use of new drugs indicated in treatment the IBS
- Patient has a history of inflammatory bowel diseases, complicated diverticulosis (i.e. diverticulitis), ischaemic colitis, microscopic colitis.
- Patient has a history of organic abnormalities of the GI tract, intestinal: obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aorto-iliac disease).
- Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
- Patient has an active biliary duct disease or a history of Sphincter of Oddi dysfunction.
- Patient has a history of gluten enteropathy.
- Patient has a history of lactose intolerance as assessed by response to diet.
- Patient has a small intestinal bacterial overgrowth.
- Patient has a current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
- Patient has a history of ectopic endometriosis.
- Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
- Patient has a history of human immunodeficiency virus infection.
- Patient has insulin-dependent diabetes mellitus.
- Patient has a major psychiatric or neurological disorder.
- Patient has an unstable medical condition, which may compromise the efficacy and safety assessments as required in the study and/or require change in concomitant medication.
- Patient has a history of abnormal thyroid function. Patient is candidate for the study if thyroid hormone replacement therapy is stable from at least 2 months.
- Patient has evidence of anemia as confirmed by hemoglobin <9 g/dl during the Screening period.
- Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. (dietary habits, lifestyle and exercise regimen should be maintained for the duration of the study).
- Use of prohibited concurrent medication within the previous month
- Pregnancy.
- Patient is not able to understand or collaborate throughout the study.
- Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.
- Concomitant participation in a biomedical research trial.
Sites / Locations
- Avicenne Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Osteopathic session
Placebo manipulative session
The osteopath put fingers on abdominal projection of the junction and sinks deeply into the abdomen until it perceives the trigger zone. Once in contact with the sphincter, it performs friction in the hourly sense, vibration, inhibitions or rebounds.
The Osteopath will touch the patient's limbs at the same place of osteopathic manipulative treatment, but without any intention of treatment and without any known and indexed reproduction techniques to simulate an osteopathic treatment, without its benefits.