Irritable Bowel Syndrome and Food Sensitivity

Irritable Bowel Syndrome Clinical Trial

Official title:

Irritable Bowel Syndrome and Food Sensitivity: Assessing Clinical Outcomes and Inflammatory Cellular Pathways

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186743
• Other study ID #: 1404013784
• Status: Completed
• Phase: N/A
• First received: July 7, 2014
• Last updated: October 16, 2017
• Start date: July 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of the clinical trial portion of this study is to assess whether an individualized dietary plan based on a commercial food sensitivity assay provides specific benefit in a randomized controlled trial in adults with irritable bowel syndrome (IBS).

Description:

This is a parallel group, randomized control trial, powered to assess changes in validated outcomes in adult patients with symptomatic irritable bowel syndrome. Subjects will receive dietary counseling and be asked to adhere to dietary instructions for 4 weeks. Assessments will occur at baseline, 4-weeks, and 8-weeks post-baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Between 18-70 years of age.

• Irritable Bowel Syndrome by Rome III criteria.

• Stable dose (30 days) of concurrent IBS medications

• Agree not to make significant changes to their diet during the study

• IBS-SSS score of >150

Exclusion Criteria:

• History of major abdominal surgeries

• History of inflammatory bowel disease

• Antibiotic use within 1 month of enrollment

• Radiation proctitis or other known poorly controlled medical conditions that could interfere with bowel function

• Current use of opioid pain medications (except for NSAIDs)

• Previous experience participating in dietary studies for IBS

• Current use of medications which are known to be affected by modest dietary changes

• Vitamin C use of >2000 mg/day

• Quercetin use of >500 mg/day

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome
• Syndrome

Intervention

Other:
• Personalized Dietary Advice
Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Cell Science Systems, Corp.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ali A, Weiss TR, McKee D, Scherban A, Khan S, Fields MR, Apollo D, Mehal WZ. Efficacy of individualised diets in patients with irritable bowel syndrome: a randomised controlled trial. BMJ Open Gastroenterol. 2017 Sep 20;4(1):e000164. doi: 10.1136/bmjgast- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)	The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.	Baseline
Primary	Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)	The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.	4 weeks
Primary	Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)	The IBS-GIS is a single item assessment of overall IBS symptoms. It poses the question to study participants "Compared to the way you felt before you entered the study, have your IBS symptoms over the past 7 days been:" Subjects respond on a scale of 1-7 where: 1 = Substantially Worse, 2 = Moderately Worse, 3 = Slightly Worse, 4 = No Change, 5 = Slightly Improved, 6 = Moderately Improved, 7 = Substantially Improved.	8 weeks
Secondary	Irritable Bowel Syndrome Adequate Relief (IBS-AR)	The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."	Baseline
Secondary	Irritable Bowel Syndrome Adequate Relief (IBS-AR)	The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."	4 weeks
Secondary	Irritable Bowel Syndrome Adequate Relief (IBS-AR)	The IBS-AR is a single item assessment of IBS symptom relief. It poses the question to study participants "Over the past week have you had adequate relief of your IBS symptoms?" Subjects respond either "yes" or "no."	8 weeks
Secondary	Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)	The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.	Baseline
Secondary	Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)	The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.	4 weeks
Secondary	Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)	The IBS-SSS contains five questions that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distention, dissatisfaction with bowel habits, and interference with quality of life.	8 weeks
Secondary	Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)	The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.	Baseline
Secondary	Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)	The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.	4 weeks
Secondary	Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)	The IBS-QoL is a 34-item measure assessing the degree to which IBS interferes with patient quality of life. Each item is rated on a 5-point Likert scale and a linear transformation yields a summed score with a theoretical range of 0 to 100, with a higher score indicating better quality of life.	8 weeks

External Links

•   BMJ Open Gastroenterology