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Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

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ClinicalTrials.gov Identifier: NCT03035799
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This pilot study proposes to gain a better understanding of the health benefits of the popular "paleo-diet" in patients with irritable bowel syndrome (IBS) and explore underlying mechanisms of benefit.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Paleolithic diet Other: General Healthful Diet Not Applicable

Detailed Description:
In the proposed study, the primary hypothesis is that, compared with a customary diet, consumption of a paleo-diet will improve psychological and gastrointestinal symptoms in patients with irritable bowel syndrome. Investigators also hypothesize consumption of the Paleolithic diet will result in decreased intestinal permeability, decreased inflammatory markers, and changes in the gut microbiome and microbiologic profiles.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Actual Study Start Date : April 24, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: Paleolithic Diet
Paleolithic Diet
Other: Paleolithic diet
Paleolithic diet

Active Comparator: General Healthful Diet
General Healthful Diet
Other: General Healthful Diet
General Healthful Diet




Primary Outcome Measures :
  1. Vitality [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Vitality as measured on the vitality subscale of the short form health survey (SF36). This instrument assesses vitality (energy level and fatigue) and is a subscale of SF36, a general health survey designed for use in clinical practice and research, health policy evaluation and general population surveys. The Vitality Subscale score is determined by responses to 4 items: Did you feel full of life? Did you have a lot of energy? Did you feel worn out? Did you feel tired? The lower the score the more disability. The higher the score the less disability.


Secondary Outcome Measures :
  1. Anxiety [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]

    Anxiety as measured by the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire.

    GAD-7 Questionnaire: This is a 7 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate detection of anxiety as well as for longitudinal anxiety symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.


  2. Depression [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]

    Depression as measured by the Patient Health Questionnaire-9' (PHQ-9) questionnaire.

    PHQ-9: This is a 9 item inventory rated on a 4 point Likert-type scale. Its purpose is to allow for brief and accurate diagnosis of depression as well as for longitudinal depression symptom evaluation. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.


  3. Activity level [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Activity level/amount of exercise as measured by the Godin Leisure-Time Exercise Questionnaire. The Godin Leisure-Time Exercise Questionnaire is a simple questionnaire to measure a person's leisure time exercise. It is designed to be reliable valid and easy to complete quickly without a need for detailed review. Lower scores indicate less activity and higher scores equal more activity.

  4. Gastrointestinal symptoms [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]

    Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale

    a. NIH-Promis Gastrointestinal Symptom Scales for 8 domains: Gastroesophageal reflux (13 items), disrupted swallowing (7 items), diarrhea (5 items), bowel incontinence/soilage (4 items), nausea and vomiting (4 items), constipation (9 items), belly pain (6 items), and gas/bloat/flatulence (12 items). Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.


  5. Visceral sensitivity [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Visceral sensitivity as measured by the Visceral Sensitivity Index. Visceral Sensitivity Index assesses gastrointestinal-specific anxiety, the cognitive, affective, and behavioral response to fear of gastrointestinal sensations, symptoms, and the context in which these visceral sensations and symptoms occur. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.

  6. Overall health status (Short Health Scale) [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Overall health status as measured by the Short Health Scale questionnaires. The "Short Health Scale" is a 4-item questionnaire covering aspects of subjective health. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.

  7. Overall health status (EQ-5D) [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Overall health status (global health outcomes measure) as measured by the EuroQol 5 Dimension (EQ-5D) The EQ-5D descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Scores range from 5-25, with higher scores indicating more severe symptoms/decreased quality of life.descriptive system consists of five dimensions: Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression. Lower scores indicate less severe symptoms and higher scores equal more severe symptoms.


Other Outcome Measures:
  1. Intestinal permeability [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Change in intestinal permeability as measured by plasma zonulin levels

  2. Change in inflammatory markers [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Change in inflammatory markers as measured by serum C-reactive protein levels

  3. Change in stool metabolomics [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Change in stool metabolomics as measured by stool metabolite testing.

  4. Change in stool microbiome profile [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Change in stool microbiota profile as measured by 16S DNA sequencing of stool samples.

  5. Biobank specimen collection of urine. [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

  6. Biobank specimen collection of stool. [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

  7. Biobank specimen collection of saliva. [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies

  8. Biobank specimen collection of blood. [ Time Frame: The change between baseline and 4 weeks (post-intervention). ]
    Biobank specimen collection of stool, blood, urine, and saliva to be studied in future studies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with mild to moderate Irritable Bowel Syndrome (IBS) and mild to moderate anxiety or depression
  • Other causes of bowel symptoms excluded to the satisfaction of the Study Team
  • Age at least 18 years at initial screening visit
  • Patients who are able to sign and understand the study's informed consent form
  • Patients able to complete all screening evaluations and procedures

Exclusion Criteria:

  • Patients in inpatient hospital care
  • Severe or refractory bowel or psychological symptoms
  • Current consumption of a Paleolithic diet
  • Known Celiac disease
  • Uncontrolled thyroid disease as indicated by an abnormal thyroid stimulating hormone (TSH) level
  • Uncontrolled diabetes as indicated by a HbA1c equal to 6.5 or greater
  • Patients unable to speak English
  • Inability to obtain informed consent
  • Pregnant or nursing women
  • Any condition, which in the opinion of the investigator, would interfere with study requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035799


Contacts
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Contact: Kristen Weaver, PhD 410-550-6871 kweave22@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Pankaj Pasricha    443-866-3693      
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Pankaj Pasricha, MD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03035799     History of Changes
Other Study ID Numbers: IRB00082222
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases