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Osteopathic Approach in Inflammatory Bowel Diseases

E

Ecole Professionnelle des Osteopathes du Quebec

Status

Unknown

Conditions

Inflammatory Bowel Diseases (IBD)

Treatments

Other: Manual Therapy: osteopathy

Study type

Interventional

Funder types

Other

Identifiers

NCT04805749
OSTEO in subjects with IBD

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

Osteopathic manipulation
Experimental group
Description:
Spinal Mobilisation / Cranial Osteopathy therapy / Circulatory Techniques / Visceral osteopathic therapy
Treatment:
Other: Manual Therapy: osteopathy

Trial contacts and locations

0

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Central trial contact

Reyhan El Kares, PhD; Valérie Conway, PhD

Data sourced from clinicaltrials.gov

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