Crohn's Disease Clinical Trial
Official title:
Treatment With Lactobacillus Rhamnosus and Lactobacillus Acidophilus for Patients With Active Colonic Crohn’s Disease.
The purpose of this study is to determine whether a probiotic containing Lactobacillus Acidophilus and Lactobacillus Rhamnosus is effective as treatment for patients with active colonic Crohn's disease
The aetiology of Crohn’s disease is still not known. In the recent years there has been an
increasing interest in the relationship between the gastrointestinal flora and gut function.
Several studies have shown promising results for the use of probiotics in patient with
inflammatory bowel disease.
Aim: The aim of the current study is to evaluate the effect of a probiotic suspension in
patients with active colonic Crohn’s disease.
Methods: The study is a two-centre, randomised placebo-controlled, and double-blind trial.
Patients above the age of 18 years, attending our out-patient clinic, can be included if
they have Crohn’s disease in the colon or colon and small bowel and have active disease with
a CDAI: 220-400. Patients are not included if they have undergone larger bowel resections,
have been treated with antibiotics within the last two months, if dose of prednisolone has
been changed within the last 4 weeks, or dose of immunosuppressives has been changed within
the last 2 months. During the study period no changes in medication is allowed. During an 8
week period patients are treated with a combination of lactobacillus rhamnosus strain
19070-2 and lactobacillus acidophilus strain 18911-2 (10EE9 colony forming unit/ml).
Freeze-dried probiotics are dissolved in sterile water to a volume of 1 ml which is ingested
once daily, in the evening.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03815851 -
Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery
|
N/A | |
| Not yet recruiting |
NCT06100289 -
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
|
Phase 3 | |
| Completed |
NCT02883452 -
A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
|
Phase 1 | |
| Recruiting |
NCT04777656 -
Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.
|
Phase 3 | |
| Terminated |
NCT03017014 -
A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
|
||
| Recruiting |
NCT05428345 -
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
|
||
| Recruiting |
NCT06053424 -
Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease
|
Phase 1 | |
| Completed |
NCT02508012 -
Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases
|
N/A | |
| Terminated |
NCT02882841 -
MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients
|
N/A | |
| Not yet recruiting |
NCT02858557 -
The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases
|
N/A | |
| Completed |
NCT02542917 -
Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
|
||
| Completed |
NCT03010787 -
A First Time in Human Study in Healthy Volunteers and Patients
|
Phase 1 | |
| Terminated |
NCT02417974 -
Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)
|
Phase 2 | |
| Active, not recruiting |
NCT02316678 -
Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics
|
N/A | |
| Completed |
NCT02193048 -
Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
|
||
| Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
| Completed |
NCT02154425 -
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
|
Phase 1 | |
| Completed |
NCT02265588 -
Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).
|
N/A | |
| Recruiting |
NCT02395354 -
Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease
|
N/A | |
| Completed |
NCT01951326 -
Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease
|
Phase 3 |