Crohn DiseaseNCT03512327
Autoimmune Protocol Diet and Inflammatory Bowel Disease
A study testing Autoimmune protocol (AIP) diet in people with Crohn Disease and Ulcerative Colitis, run by Scripps Health.
Trial summary
There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis, Inflammatory Bowel Diseases
- What is being tested?
- Autoimmune protocol (AIP) diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 10 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age
- Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
- Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
- Confirmation of active CD or UC with recent (within 6 months of consent or prior to study start) objective evidence of endoscopically active disease on colonoscopy or computed tomography/magnetic resonance enterography or video capsule endoscopy
- Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
- Current disease activity defined as a Harvey Bradshaw index ≥ 5 at baseline for CD or Partial Mayo Score ≥ 3 for UC
- Established Facebook account
- Comfortable with internet-based surveys and email
Who cannot join
- If female, is pregnant or is breast feeding
- Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
- Inability to provide informed consent or unwilling to participate
- Evidence of untreated infection (e.g. Clostridium difficile)
- Presence of stoma or J pouch
- Bowel surgery within 12 weeks prior to enrollment and/or has surgery planned or deemed likely for inflammatory bowel disease during the study period
- Use of tube or enteral feeding, elemental diet, or parenteral alimentation within 4 weeks prior to study initiation
About this study
Official title: Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease
There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).
Read the detailed description
The investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune paleo (AIP) diet in patients with Crohn's disease (CD) and ulcerative colitis (UC).
Specific aims:
- To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC,
- To examine changes in inflammatory biomarkers during AIP diet
- To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study.
- To characterize changes in fecal microbiome during diet intervention
- Being tested
- Autoimmune protocol (AIP) diet
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autoimmune protocol (AIP) dietOther
Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune protocol (AIP) diet | Experimental | Adult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy Receives: Other: Autoimmune protocol (AIP) diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Remission for Crohn's Disease
Clinical disease activity scores will be measured by Harvey Bradshaw Index for patients with Crohn's Disease (CD). The Harvey Bradshaw Index measures general well being, abdominal pain severity, number of stools daily, presence of abdominal mass, and complications. The Harvey Bradshaw Index ranges from 0-16, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Harvey Bradshaw Index <5 for CD.
Measured: 11 weeks
Number of Participants With Clinical Remission for Ulcerative Colitis
Clinical disease activity scores will be measured by Mayo score for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. The Mayo score ranges from 0-12, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Mayo score 2 or less for UC.
Measured: 11 weeks
Secondary outcomes (5)
Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis
Number of participants with Crohn's disease or ulcerative colitis who have absence of erosions or ulcers on endoscopy or imaging
Measured: 11 weeks
Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention
Number of Participants with a change in C-reactive Protein Levels (inflammatory biomarker) from baseline to 11 weeks.
Measured: 11 weeks
Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention
Number of Participants with a change in fecal calprotectin levels (inflammatory biomarker) from baseline to 11 weeks.
Measured: 11 weeks
Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
Description of changes in RNA expression from colonic biopsies from patients with ulcerative colitis from baseline to end of study (11 weeks). Specifically, examined top 10 major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
Measured: 11 weeks
Changes in Fecal Microbiome Composition During Dietary Intervention
Changes in fecal microbiome composition at baseline and at weeks 2, 4, 6, and 11 using 16S ribosomal RNA sequencing
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start1 Sep 2016
- Primary completion10 Dec 2016
- Study completion10 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn DiseaseStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gauree G. Konijeti, Scripps Health
- Investigators
- Gauree G Konijeti, MD, MPH, Principal investigator, Gastroenterologist, Clinical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03512327
- Sponsor's protocol ID
- 16-6774
- Status last verified
- Dec 2024
- First submitted
- 26 Feb 2018
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Autoimmune Protocol Diet for Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT03512327
- Acronym / sponsor ID
- 16-6774
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 10 Dec 2016 (actual)
- Study completion
- 10 Dec 2016 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is limited data to guide the use of dietary change in the management of IBD, and it can prove challenging to implement in the setting of altered anatomy, comorbid conditions, and patient compliance. Therefore there is an important need to study diet as a therapy for IBD. Here, the investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune protocol (AIP) diet in patients with active Crohn's disease (CD) and ulcerative colitis (UC).
Detailed description
The investigators propose a novel study to evaluate the feasibility and efficacy of the autoimmune paleo (AIP) diet in patients with Crohn's disease (CD) and ulcerative colitis (UC).
Specific aims:
- To evaluate the effect of the AIP diet on clinical and endoscopic disease activity for CD and UC,
- To examine changes in inflammatory biomarkers during AIP diet
- To characterize changes in RNA expression from intestinal mucosal biopsy specimens from prior to diet initiation to end of the study.
- To characterize changes in fecal microbiome during diet intervention
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autoimmune protocol (AIP) diet | Experimental | Other: Autoimmune protocol (AIP) dietAdult patients with active Crohn's disease or ulcerative colitis, undergoing 11 week autoimmune protocol diet, to examine therapeutic efficacy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age
- Able to provide written informed consent prior to screening and to comply with the requirements of the study protocol.
- Established diagnosis of small bowel CD or colonic CD or ulcerative colitis
- Confirmation of active CD or UC with recent (within 6 months of consent or prior to study start) objective evidence of endoscopically active disease on colonoscopy or computed tomography/magnetic resonance enterography or video capsule endoscopy
- Any medications being currently used for IBD must remain stable during the study period with the exception of tapering of corticosteroids.
Key exclusion criteria (7 listed)
- If female, is pregnant or is breast feeding
- Known celiac disease or subjects with a positive screen for celiac disease (elevated tissue transglutaminase antibodies)
- Inability to provide informed consent or unwilling to participate
- Evidence of untreated infection (e.g. Clostridium difficile)
- Presence of stoma or J pouch
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 |
|---|---|---|
| Autoimmune protocol (AIP) dietAutoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase. | Other | Autoimmune protocol (AIP) diet |
Primary outcome
Number of Participants With Clinical Remission for Crohn's Disease
Time frame: 11 weeks
Clinical disease activity scores will be measured by Harvey Bradshaw Index for patients with Crohn's Disease (CD). The Harvey Bradshaw Index measures general well being, abdominal pain severity, number of stools daily, presence of abdominal mass, and complications. The Harvey Bradshaw Index ranges from 0-16, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Harvey Bradshaw Index <5 for CD.
Number of Participants With Clinical Remission for Ulcerative Colitis
Time frame: 11 weeks
Clinical disease activity scores will be measured by Mayo score for patients with ulcerative colitis (UC). The Mayo score includes measures of stool frequency, rectal bleeding, physician global assessment, and endoscopic assessment. The Mayo score ranges from 0-12, with lower values representing better outcome and higher values representing more disease activity. Clinical remission is defined as Mayo score 2 or less for UC.
5 secondary outcomes
Number of Participants With Mucosal Healing for Crohn's Disease or Ulcerative Colitis
Time frame: 11 weeks
Changes in Inflammatory Biomarkers, Including C-reactive Protein (CRP), During Dietary Intervention
Time frame: 11 weeks
Changes in Inflammatory Biomarkers, Including Fecal Calprotectin (FC), During Dietary Intervention
Time frame: 11 weeks
Major Biological Processes Gene Ontology Terms Enriched in Downregulated and Upregulated Genes
Time frame: 11 weeks
Changes in Fecal Microbiome Composition During Dietary Intervention
Time frame: 11 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool
Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis), Inflammatory Bowel Syndrome
RecruitingPhase 3
Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011)
Crohn Disease, Colitis, Ulcerative
Active, not recruitingPhase 4
Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) and Diet in Inflammatory Bowel Disease (IBD) Patients
Crohn Disease
RecruitingPhase 2
NOV-ERA - A Clinical Trial to Assess the Efficacy and Safety of Ontunisertib Compared to Placebo in Patients With Fibrostenosing Crohn's Disease
Fibrostenotic Crohn's Disease
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.
Gauree G Konijeti, MD, MPH principal investigator
Gastroenterologist, Clinical Investigator
Questions about this trial
What is this clinical trial studying?
A study testing Autoimmune protocol (AIP) diet in people with Crohn Disease and Ulcerative Colitis, run by Scripps Health.
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 8 inclusion and 7 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Clinical Remission for Crohn's Disease (time frame: 11 weeks). The study lists 2 primary outcomes in all. 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 9 Jan 2025.