Clinical trial NCT03035799: Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Official title: A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-01-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Vitality
timeFrame: The change between baseline and 4 weeks (post-intervention).
Secondary outcomes:
measure: Anxiety
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Depression
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Activity level
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Gastrointestinal symptoms
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Visceral sensitivity
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Overall health status (Short Health Scale)
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Overall health status (EQ-5D)
timeFrame: The change between baseline and 4 weeks (post-intervention).
Other outcomes:
measure: Intestinal permeability
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Change in inflammatory markers
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Change in stool metabolomics
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Change in stool microbiome profile
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Biobank specimen collection of urine.
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Biobank specimen collection of stool.
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Biobank specimen collection of saliva.
timeFrame: The change between baseline and 4 weeks (post-intervention).
measure: Biobank specimen collection of blood.
timeFrame: The change between baseline and 4 weeks (post-intervention).
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Pankaj Pasricha, MD
role: PRINCIPAL_INVESTIGATOR
References: