Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

Completed · Not applicable

Conditions studied: Irritable Bowel Syndrome

In brief

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.

Key facts

Study ID

NCT03035799

Run by

Johns Hopkins University

People needed

40

Starts

2018-04-24

Expected to finish

2020-04-01

Last updated by the study team

2020-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Johns Hopkins University — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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