Clinical trial NCT04805749: Osteopathic Approach in Inflammatory Bowel Diseases
Official title: Efficacy of Visceral Osteopathic Approach to Relieve Recurring Digestive Symptoms in Subjects With Inflammatory Bowel Diseases (IBS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inflammatory Bowel Diseases (IBD)
Lead sponsor: Ecole Professionnelle des Osteopathes du Quebec
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Crohn's disease (CD) and ulcerative colitis are bowel disease (IBS) with an autoimmune component believed to affect approximately 1 in 140 Canadians. Despite this high prevalence, more than 30% patients with IBD have to live with recurrent gastrointestinal symptoms that is poorly relieved by allopathic medicine. Numerous studies have shown that the quality of life of individuals with IBS is lower than that of the general population. Since visceral manipulations have been shown to be effective in reducing the main discomforts associated with IBS during clinical interventions, it seems likely that it may provide similar relief to patients with IBD. To our best knowledge, no study has evaluated the impact of osteopathic manual therapy on neuro-immuno-vascular modulation of intestine to reduce IBS symptoms.

The aim of this study is to assess the relevance of an osteopathic approach addressing the brain-intestine axis in order to improve symptomatology in subject suffering from IBD by modulating inflammation and vagal tone.

Detailed description: For this study, 10 to 12 participant (18 to 65 years) with Inflammatory Bowel Disease (in remission state) will be recruited to receiving visceral osteopathic therapy. Participant will received four standardized osteopathic session of 45 minutes (1 session every 7 days: week 0, 1, 2 and 3) and a follow up visit at week 4. The osteopathic protocol will specifically address the gut-to-brain neuro-immuno-vascular axis.

Global quality of life and severity of IBS-like symptoms will be a assess at week 0, 2 and 4 using three standardized questionnaires. Gut permeability and intestinal inflammation will be assessed at week 0 and 4 by measuring Zonulin (pre-Haptoglobin 2), Histamine and Diamine Oxidase (DO) levels respectively. Vagal tone at the beginning and at the end of each osteopathic session will be evaluate using heart rate variability (HRV) measurements.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with inflammatory bowel disease (IBD) in remission state;
* Subjects must suffer form recurrent digestive symptoms fulfilling the Rome III criteria;
* Subjects' eating habits should be stable prior to the study.

Exclusion Criteria:

* Concomitant diagnosis of celiac disease or multiple food intolerance;
* Concomitant diagnosis of rheumatologic disease;
* Obesity (BMI ≥ 30);
* Concomitant diagnosis of severe depression or severe anxiety;
* Unstable thyroid or kidney condition;
* Subjects on antidepressant, anti-inflammatory (steroids) or analgesic (paracetamol, aspirin) will be excluded from the study;
* Smokers, patients with problematic alcohol consumption or consuming drugs will be excluded from the study;
* High performance athletes will be excluded from the study.

Primary outcomes:
measure: Mean Change from baseline in gut permeability marker
timeFrame: Week 0 (baseline); Week 4
measure: Mean Change from baseline in intestinal inflammation markers
timeFrame: Week 0 (baseline); Week 4
measure: Mean Change from baseline in vagally mediated Heart Rate Variability (HRV)
timeFrame: Week 0 ; Week 1; Week 2; Week 3
Secondary outcomes:
measure: Mean Change from baseline in Irritable Bowel Syndrome (IBS) like symptoms
timeFrame: Week 0 (baseline); Week 2; Week 4
measure: Mean Change from baseline in Quality of Life Score
timeFrame: Week 0 (baseline); Week 2; Week 5
measure: Mean Change from baseline in Anxiety and Depression Score
timeFrame: Week 0 (baseline); Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Clinique Expertise Santé
name: Valérie Conway, PhD
role: PRINCIPAL_INVESTIGATOR
References: