Synbiotic Treatment in Crohn's Disease Patients

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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

The purpose of this study is to determine whether administration of a synbiotic, comprised on inulin and a bifidobacterial probiotic will colonise the gut wall and down-regulate TNF-alpha and other pro-inflammatory cytokines in the mucosa of Crohn's patients with active disease to reduce mucosal inflammation and induce remission.

Related Clinical Trials

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

Synbiotic Treatment of Ulcerative Colitis Patients

NCT00803829

Ulcerative Colitis

COMPLETED NA

Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery

NCT00688636

Crohn's Disease

COMPLETED PHASE4

Synbiotics and Post-op Crohn's Disease

NCT04804046

Crohn's Disease

TERMINATED NA

Safety and Efficacy of EcoActive on Intestinal Adherent Invasive E. Coli in Patients With Inactive Crohn's Disease

NCT03808103

Crohn Disease

ACTIVE_NOT_RECRUITING PHASE1/PHASE2

Observational, Real World Study Of Inflectra In Patients With Inflammatory Bowel Disease

NCT03801928

Inflammatory Bowel Disease (IBD) Crohn's Disease (CD) Ulcerative Colitis (UC)

COMPLETED

Detailed Description

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

Crohn's disease is one of the two main forms of idiopathic inflammatory bowel disease. The Th1-mediated inflammatory response in Crohn's disease is characterised by increased IL-18 and INF-gamma and especially TNF-alpha, which are formed by lamina propria mononuclear cells. The aim of this investigation is to determine whether a synbiotic comprised of inulin and a bifidobacterial probiotic, that we have previously shown to down-regulate TNF-alpha and other proinflammatory cytokines in the gut mucosa in ulcerative colitis patients with active disease, can colonise the bowel wall, reduce mucosal inflammation and induce remission in Crohn's disease patients with active disease, in a randomised controlled trial. Crohn's disease is associated with high mortality and incurs significant social, commercial and NHS costs. Many patients are refractile to standard treatments, which often have undesirable side effects. An inexpensive, effective and non-toxic treatment based on the synbiotic concept would contribute greatly to relieving the clinical and financial burdens of the disease.

Conditions

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

Crohn's Disease

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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

Synbiotic (Synergy I / B.longum)

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* Crohn's disease of large bowel (+/- small bowel disease)
* 18-79 years old
* stable doses of medications
* CDAI \>150, \<450

Exclusion Criteria

* short gut syndrome
* pregnancy
* lactation
* antibiotic therapy in last 3 months
* probiotic therapy in last 1 month
* \<18, \>79 years old
* CDAI \<150 or \>450
* indeterminate colitis, ulcerative colitis
* alterations to medications in last 3 months

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No