Osteopathic Approach in Inflammatory Bowel Diseases

Efficacy of Visceral Osteopathic Approach to Relieve Recurring Digestive Symptoms in Subjects With Inflammatory Bowel Diseases (IBS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Bowel Diseases (IBD)
• Intervention / Treatment: Other: Manual Therapy: osteopathy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Valérie Conway, PhD; Phone Number: 1-418-658-2341; Email: info@valerieconway.com
• Study Contact Backup: Name: Reyhan El Kares, PhD; Phone Number: 1-514-647-8465; Email: relkares@epoqosteopathie.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Osteopathic manipulation; Spinal Mobilisation / Cranial Osteopathy therapy / Circulatory Techniques / Visceral osteopathic therapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from baseline in Irritable Bowel Syndrome (IBS) like symptoms	Irritable Bowel Severity Scoring System (IBS-SSS)* The maximum severity of symptom score achievable is 500; Normal score <75 (remission); Mild score: 75-174; Moderate score:175-300; Severe score: >300Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997;11(2):395-402.	Week 0 (baseline); Week 2; Week 4
Mean Change from baseline in Quality of Life Score	Irritable Bowel Syndrome Quality Of Life assessment (IBS-QOL)* 34 items (scale 1 to 5) consisting of 8 subscale domains. The maximum score achievable is 175 Sub-scale domains: Dysphoria: 8 items; maximum score = 40; Interference with activity: 7 items; maximum score = 35; Body image: 4 items; maximum score= 20; Health worry: 3 items; maximum score = 15; Food avoidance 3 items; maximum score = 15; Social reaction 4 items; maximum score = 20; Sexual: 2 items; maximum score = 10; Relationship: 3 items; maximum score = 15Patrick DL, Drossman DA, Frederick IO, DiCesare J, Puder KL. Quality of life in persons with irritable bowel syndrome: development and validation of a new measure. Dig Dis Sci. 1998;43(2):400-11.	Week 0 (baseline); Week 2; Week 5
Mean Change from baseline in Anxiety and Depression Score	Anxiety and depression levels according to the Hospital Anxiety And Depression Scale questionnaire (HADS)* 0-7 = Normal 8-10 = Borderline abnormal (borderline case) 11-21 = Abnormal (case) *Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003;1:29.	Week 0 (baseline); Week 4

Collaborators and Investigators

• Sponsor: Ecole Professionnelle des Osteopathes du Quebec
• Investigators: Principal Investigator: Valérie Conway, PhD, Clinique Expertise Santé

Study record dates

Study Major Dates

• Study Start (Anticipated): April 15, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 17, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: OSTEO in subjects with IBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No