Osteopathic Approach in Inflammatory Bowel Diseases

NCT04805749 | Unknown

• 1 other identifier: OSTEO in subjects with IBD
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Diseases (IBD)

Outcome Measures

Primary Outcomes (3)

• Mean Change from baseline in gut permeability marker

  Zonulin (pre-Haptoglobin 2) on dried blood spot will be performed by FLUIDS iQ's analytical testing services (Intestinal iQ™ test kit). Zonulin (Pre-Haptoglobin 2) is a protein found in intestinal cells, with production and release mimicking the effect of certain bacterial toxins on the tight junctions of the small intestine. Zonulin binds to a specific receptor only on the luminal surface of the intestinal epithelia and triggers a cascade of biochemical processes that induces tight junction (TJ) disassembly and a subsequent permeability increase of the intestinal epithelia. The Zonulin range is from 1 to 20 ng/ml. Values between 1 and 6 ng/ml are considered as optimal Values between 6 and 10 ng/ml are considered as borderline Values from 10 to 20 ng/ml are considered as elevated

  Week 0 (baseline); Week 4

• Mean Change from baseline in intestinal inflammation markers

  Histamine (ng/ml), Diamine Oxidase (DAO) on dried blood spot will be performed by FLUIDS iQ's analytical testing services (Intestinal iQ™ test kit). HISTAMINE * Normal reference range: 0.2 to 2.4 ng/ml * Below reference range: \< 0.2 ng/ml * Above reference range: \> 2.4 ng/ml DAO * Normal reference range: 12.5 to 3.75 ng/ml * Below reference range, \< 3.75 ng/ml * Above reference range, \> 12.5 ng/ml

  Week 0 (baseline); Week 4

• Mean Change from baseline in vagally mediated Heart Rate Variability (HRV)

  The root mean square of successive differences between normal heartbeats (RMSSD) and Heart Rate Variability (HRV) will be recorded using Ultra-Short-Term measurement protocol (1-min resting). HRV and RMSSD will be measured at the start and at the end of each session. \*Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Frontiers in Public Health. 2017;5(258).

  Week 0 ; Week 1; Week 2; Week 3

Secondary Outcomes (3)

• Mean Change from baseline in Irritable Bowel Syndrome (IBS) like symptoms

  Week 0 (baseline); Week 2; Week 4

• Mean Change from baseline in Quality of Life Score

  Week 0 (baseline); Week 2; Week 5

• Mean Change from baseline in Anxiety and Depression Score

  Week 0 (baseline); Week 4

Study Arms (1)

Osteopathic manipulation

EXPERIMENTAL

Spinal Mobilisation / Cranial Osteopathy therapy / Circulatory Techniques / Visceral osteopathic therapy

Other: Manual Therapy: osteopathy

Interventions

Manual Therapy: osteopathy OTHER

Osteopathic protocol applied at week 0, 1, 2 and 3: 1. Spinal mobilisation of L1, L2 and L3 vertebrae to stimulate the arterial supply of mesenteric attachments of the colon and small intestine. 2. Visceral osteopathic therapy to address adhesions/ fixations in the presacral fascia, Toldt fascia, posterior peritoneum and caudal peritoneum. 3. Circulatory techniques to stimulate the celiac plexus, the superior and inferior ganglia. 4. Cranial osteopathy techniques to address the vagus parasympathetic nerves.

Osteopathic manipulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ecole Professionnelle des Osteopathes du Quebec: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Valérie Conway, PhD

  Clinique Expertise Santé

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valérie Conway, PhD

CONTACT

1-418-658-2341; info@valerieconway.com

Reyhan El Kares, PhD

CONTACT

1-514-647-8465; relkares@epoqosteopathie.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The gut inflammation and gut permeability laboratory analysis will be performed by a independent laboratory testing services (FLUIDS iQ® Inc.,Ontario, Canada)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Osteopath and Naturopath at Clinique Expertise Santé, PhD in food sciences

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 18, 2021
• Study Start: April 15, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share