Irritable Bowel SyndromeNCT03035799
Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
A study testing Paleolithic diet and General Healthful Diet in people with Irritable Bowel Syndrome, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Paleolithic diet and General Healthful Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
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.
Read the 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.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Paleolithic diet, General Healthful Diet
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paleolithic dietOther
Paleolithic diet
General Healthful DietOther
General Healthful Diet
| Study group | Role | What they receive |
|---|---|---|
| Paleolithic Diet | Experimental | Paleolithic Diet Receives: Other: Paleolithic diet |
| General Healthful Diet | Active comparator | General Healthful Diet Receives: Other: General Healthful Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitality
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Secondary outcomes (7)
Anxiety
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Depression
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Activity level
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Gastrointestinal symptoms
Gastrointestinal symptoms as measured by the NIH-Promis Gastrointestinal Symptom Scale
- 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.
Measured: The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Overall health status (Short Health Scale)
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Overall health status (EQ-5D)
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.
Measured: The change between baseline and 4 weeks (post-intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start24 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pankaj Pasricha, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035799
- Sponsor's protocol ID
- IRB00082222
- Status last verified
- May 2020
- First submitted
- 18 Jan 2017
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing Two Types of Diets on Psychological and Gastrointestinal Symptoms
- ClinicalTrials.gov ID
- NCT03035799
- Acronym / sponsor ID
- IRB00082222
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 24 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paleolithic Diet | Experimental | Other: Paleolithic dietPaleolithic Diet |
| General Healthful Diet | Active comparator | Other: General Healthful DietGeneral Healthful Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paleolithic dietPaleolithic diet | Other | Paleolithic Diet |
| General Healthful DietGeneral Healthful Diet | Other | General Healthful Diet |
Primary outcome
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.
7 secondary outcomes
Anxiety
Time frame: The change between baseline and 4 weeks (post-intervention).
Depression
Time frame: The change between baseline and 4 weeks (post-intervention).
Activity level
Time frame: The change between baseline and 4 weeks (post-intervention).
Gastrointestinal symptoms
Time frame: The change between baseline and 4 weeks (post-intervention).
Visceral sensitivity
Time frame: The change between baseline and 4 weeks (post-intervention).
Overall health status (Short Health Scale)
Time frame: The change between baseline and 4 weeks (post-intervention).
Overall health status (EQ-5D)
Time frame: The change between baseline and 4 weeks (post-intervention).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pankaj Pasricha, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paleolithic diet and General Healthful Diet in people with Irritable Bowel Syndrome, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitality (time frame: The change between baseline and 4 weeks (post-intervention).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.