Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms

Johns Hopkins University

Status

Completed

Conditions

Irritable Bowel Syndrome

Treatments

Other: General Healthful Diet

Other: Paleolithic diet

Study type

Interventional

Funder types

Other

Identifiers

NCT03035799

IRB00082222

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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