Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2028-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. To this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (IBD) with and without associated primary sclerosing cholangitis (PSC-IBD).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Inflammatory Bowel Disease - Anti-Inflammatory Diet (IBD-AID)

NCT04757181

Inflammatory Bowel Diseases

COMPLETED NA

Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease

NCT06719778

Crohn's Disease

RECRUITING NA

Prebiotics and Diet to Reduce "Leaky" Gut in First Degree Relatives of Crohn's Disease Patients

NCT03950336

Healthy First Degree Relatives of Crohn's Disease Patients

COMPLETED NA

Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease

NCT03058679

Crohn Disease

COMPLETED NA

Prebiotic Effect on Metabolites in Crohn's Disease

NCT01487759

Crohn Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reduction of Intestinal Inflammatory Activity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gluten-free diet in Crohn disease

Group Type ACTIVE_COMPARATOR

Gluten-free diet

Intervention Type DIETARY_SUPPLEMENT

Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Gluten-free diet in ulcerative colitis

Group Type ACTIVE_COMPARATOR

Gluten-free diet

Intervention Type DIETARY_SUPPLEMENT

Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Gluten-free diet in Primary sclerosing cholangitis

Group Type ACTIVE_COMPARATOR

Gluten-free diet

Intervention Type DIETARY_SUPPLEMENT

Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gluten-free diet

Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed diagnosis of UC, CD or PSC-IBD
* Willingness, to follow a gluten-free diet for 78 weeks
* Stable therapeutic treatment for more 8 weeks
* For CD: Harvey Bradshaw index (HBI) of more 5 points, corresponding to a minimum of mild intestinal inflammation in CD
* For UC: Mayo Score of more 2 points, corresponding to a minimum of mild intestinal inflammation in UC
* Patient signed informed consent

Exclusion Criteria

* Antibiotics during last 4 weeks
* Intake of probiotics
* Gluten-free diet is already practiced
* Concomitant diagnosis of celiac disease
* Positive serology for transglutaminase IgA / IgG antibody or deamidated gliadin IgA / IgG
* Breast feeding
* Pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes