Osteopathic Approach in Inflammatory Bowel Diseases
Primary Purpose
Inflammatory Bowel Diseases (IBD)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual Therapy: osteopathy
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Bowel Diseases (IBD)
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Osteopathic manipulation
Arm Description
Spinal Mobilisation / Cranial Osteopathy therapy / Circulatory Techniques / Visceral osteopathic therapy
Outcomes
Primary Outcome Measures
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
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
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).
Secondary Outcome Measures
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: >300
Francis 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.
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 = 15
Patrick 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.
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.
Full Information
NCT ID
NCT04805749
First Posted
March 11, 2021
Last Updated
March 17, 2021
Sponsor
Ecole Professionnelle des Osteopathes du Quebec
1. Study Identification
Unique Protocol Identification Number
NCT04805749
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2021 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ecole Professionnelle des Osteopathes du Quebec
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Diseases (IBD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
The gut inflammation and gut permeability laboratory analysis will be performed by a independent laboratory testing services (FLUIDS iQ® Inc.,Ontario, Canada)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Osteopathic manipulation
Arm Type
Experimental
Arm Description
Spinal Mobilisation / Cranial Osteopathy therapy / Circulatory Techniques / Visceral osteopathic therapy
Intervention Type
Other
Intervention Name(s)
Manual Therapy: osteopathy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Change from baseline in gut permeability marker
Description
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
Time Frame
Week 0 (baseline); Week 4
Title
Mean Change from baseline in intestinal inflammation markers
Description
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
Time Frame
Week 0 (baseline); Week 4
Title
Mean Change from baseline in vagally mediated Heart Rate Variability (HRV)
Description
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).
Time Frame
Week 0 ; Week 1; Week 2; Week 3
Secondary Outcome Measure Information:
Title
Mean Change from baseline in Irritable Bowel Syndrome (IBS) like symptoms
Description
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: >300
Francis 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.
Time Frame
Week 0 (baseline); Week 2; Week 4
Title
Mean Change from baseline in Quality of Life Score
Description
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 = 15
Patrick 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.
Time Frame
Week 0 (baseline); Week 2; Week 5
Title
Mean Change from baseline in Anxiety and Depression Score
Description
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.
Time Frame
Week 0 (baseline); Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valérie Conway, PhD
Phone
1-418-658-2341
Email
info@valerieconway.com
First Name & Middle Initial & Last Name or Official Title & Degree
Reyhan El Kares, PhD
Phone
1-514-647-8465
Email
relkares@epoqosteopathie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valérie Conway, PhD
Organizational Affiliation
Clinique Expertise Santé
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Osteopathic Approach in Inflammatory Bowel Diseases
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