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Completed

NCT Number: NCT02186743

Irritable Bowel Syndrome and Food Sensitivity

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).

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Food Intolerance Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Dietary Advice

Other

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.

Primary outcomes

  1. Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)

    Time frame: Baseline

    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.

  2. Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)

    Time frame: 4 weeks

    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.

  3. Irritable Bowel Syndrome Global Improvement Scale (IBS-GIS)

    Time frame: 8 weeks

    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.

Secondary outcomes

  1. Irritable Bowel Syndrome Adequate Relief (IBS-AR)

    Time frame: Baseline

    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."

  2. Irritable Bowel Syndrome Adequate Relief (IBS-AR)

    Time frame: 4 weeks

    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."

  3. Irritable Bowel Syndrome Adequate Relief (IBS-AR)

    Time frame: 8 weeks

    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. Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)

    Time frame: Baseline

    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.

  5. Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)

    Time frame: 4 weeks

    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.

  6. Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)

    Time frame: 8 weeks

    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.

  7. Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)

    Time frame: Baseline

    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. Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)

    Time frame: 4 weeks

    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.

  9. Irritable Bowel Syndrome Quality of Life Questionnaire (IBS-QoL)

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Cell Science Systems, Corp.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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