IBS - Irritable Bowel SyndromeNCT05178017
Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
A study testing Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program in people with IBS - Irritable Bowel Syndrome, run by Oxford Biomedical Technologies, Inc. at 1 site in United States.
Trial summary
A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBS - Irritable Bowel Syndrome
- What is being tested?
- Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria
- Have IBS of at least moderate severity
- Must be on a stable dose regimen for at least 1 month prior to enrollment
- Willing to follow the LEAP program for 3 months
- Able to give informed consent
- Willing to complete the study
Who cannot join
- Individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, cancer patients under treatment, and kidney failure
- BMI of 40 or higher
- Pregnancy or planned pregnancy or lactation
- Any serious illness that will interfere with the study procedures or results
- Enrollment in active clinical trial/ experimental therapy within the last 30 days
- Currently on another dietary treatment approach
Trial locations and contacts
1 site in 1 country.
United States1 site
Oxford Biomedical Technologies, Inc.
Riviera Beach, Florida, 33404
About this study
Official title: Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.
Read the detailed description
This study will have 60 participants with Irritable bowel syndrome (IBS) for a duration of three months. The procedures will consist of anthropometric measures, blood pressure, questionnaires, and a blood sample. There will be seven visits with one including a virtual meeting with a registered dietitian involved in the Lifestyle Eating and Performance (LEAP) program. With these procedures the investigators will test the effectiveness of the LEAP program for the treatment of irritable bowel syndrome by improving inflammatory markers, symptoms, and quality of life.
- Conditions
- IBS - Irritable Bowel Syndrome
- Being tested
- Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program
- 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.
Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) programDiagnostic test
The LEAP program is based on the in-vitro Leukocyte Activation Assay (LAA-MRT) results and initially prepared with the least immune reactive foods and chemicals, and subsequent foods will be added depending on the degree of immune reactivity in a nutritionally balanced manner.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Individuals with Irritable Bowel Syndrome (IBS) Receives: Diagnostic Test: Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory blood markers
To evaluate the cytokines levels (IL-I b; IL-6; IL-8; IL-10; IL-12; IL-17; TNF-a) of participants with irritable bowel syndrome from baseline levels to 12 weeks by using a Bio-Plex 200 System (Bio-Rad, California, USA).
Measured: 3 months
Secondary outcomes (2)
Gastrointestinal symptoms severity
To evaluate gastrointestinal symptoms severity of participants with irritable bowel syndrome from baseline to 12 weeks by using the IBS-Symptom Severity Scale (IBS-SSS). Items relate to gastrointestinal pain, bowel dysfunction, and overall wellbeing will be used to evaluate IBS severity. A higher score indicating worse condition.
Measured: 3 months
The quality of life
To evaluate the quality of life of participants with irritable bowel syndrome from baseline to 12 weeks using the IBS-36 Quality of Life (IBS-36): The self-administrated IBS-36 questionnaire consists of 36 individual questions. Each question's response is scored on a 7-point Likert scale where 0 = never and 6 = always. A final score is a sum of the scores of the 36 questions. The highest possible score on the IBS-36 is 216, and the lowest is 0.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Sep 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBS - Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oxford Biomedical Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gustavo Zarini, Ph.D., RD, Principal investigator, Oxford Biomedical Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178017
- Sponsor's protocol ID
- Pro00048988
- Status last verified
- May 2025
- First submitted
- 25 Oct 2021
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Lifestyle Eating and Performance (LEAP) Program for the Treatment of Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT05178017
- Acronym / sponsor ID
- Pro00048988
- Conditions
- IBS - Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oxford Biomedical Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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.
A three month follow-up study to evaluate the effectiveness of a tailored anti-inflammatory eating plan guided by a registered dietitian to treat irritable bowel syndrome.
Detailed description
This study will have 60 participants with Irritable bowel syndrome (IBS) for a duration of three months. The procedures will consist of anthropometric measures, blood pressure, questionnaires, and a blood sample. There will be seven visits with one including a virtual meeting with a registered dietitian involved in the Lifestyle Eating and Performance (LEAP) program. With these procedures the investigators will test the effectiveness of the LEAP program for the treatment of irritable bowel syndrome by improving inflammatory markers, symptoms, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Diagnostic Test: Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) programIndividuals with Irritable Bowel Syndrome (IBS) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients with an established diagnosis of IBS-D as determined by Rome III or IV Criteria
- Have IBS of at least moderate severity
- Must be on a stable dose regimen for at least 1 month prior to enrollment
- Willing to follow the LEAP program for 3 months
- Able to give informed consent
Key exclusion criteria (6 listed)
- Individuals with a history of inflammatory bowel disease, celiac disease, abdominal surgeries, cancer patients under treatment, and kidney failure
- BMI of 40 or higher
- Pregnancy or planned pregnancy or lactation
- Any serious illness that will interfere with the study procedures or results
- Enrollment in active clinical trial/ experimental therapy within the last 30 days
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 |
|---|---|---|
| Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) programThe LEAP program is based on the in-vitro Leukocyte Activation Assay (LAA-MRT) results and initially prepared with the least immune reactive foods and chemicals, and subsequent foods will be added depending on the degree of immune reactivity in a nutritionally balanced manner. | Diagnostic test | Participants |
Primary outcome
Inflammatory blood markers
Time frame: 3 months
To evaluate the cytokines levels (IL-I b; IL-6; IL-8; IL-10; IL-12; IL-17; TNF-a) of participants with irritable bowel syndrome from baseline levels to 12 weeks by using a Bio-Plex 200 System (Bio-Rad, California, USA).
2 secondary outcomes
Gastrointestinal symptoms severity
Time frame: 3 months
The quality of life
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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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.
Gustavo Zarini, Ph.D., RD principal investigator
Oxford Biomedical Technologies, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leukocyte Activation Assay (LAA-MRT) / Lifestyle Eating and Performance (LEAP) program in people with IBS - Irritable Bowel Syndrome, run by Oxford Biomedical Technologies, Inc. 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 25 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Inflammatory blood markers (time frame: 3 months). 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 25 May 2025.